PharmaNet Development Group, Inc.
Industry: Company
DescriptionHeadquarters: Princeton, NJ Founded: 1984 Subsidiaries: PharmaNet LLC, Taylor Technology Inc, Parent organization: Syneos Health
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PharmaNet Development Group, Inc. Employees
Employee
Years
Job
Industry
Thomas Newman Thomas Newman's PharmaNet Development Group, Inc. Experience 2010 - October 2011
Job Advisory Board of Directors
Industry Pharmaceuticals
Experience
Veristat LLC April 2013 - Present
BioStorage Technologies, Inc. November 2011 - Present
PharmaNet Development Group, Inc. 2010 - October 2011
PharmaNet Development Group, Inc. 1998 - 2010
Covance 1992 - 1998
Bristol-Myers Squibb, Princeton, New Jersey 1980 - 1992
Skills
Clinical Development, CTMS, Clinical Research, Clinical Trials, Pharmaceutical Industry, Biotechnology, CRO, GCP, Oncology, Drug Development, FDA, Lifesciences, Therapeutic Areas, Regulatory Affairs, Infectious Diseases, EDC, Regulatory Submissions, Biopharmaceuticals, ICH-GCP, Immunology, Drug Discovery, Clinical Data Management, Protocol, Pharmacovigilance, Pharmacology, Neurology, Cardiology, Medical Writing, Sop, Vaccines, Clinical Monitoring, IND, Medical Affairs, Clinical Operations, Validation, GLP
Education
Tufts University School of Medicine 1970 — 1974
M.D.
Cornell University 1966 — 1970
A.B., biology
Veristat LLC April 2013 - Present
BioStorage Technologies, Inc. November 2011 - Present
PharmaNet Development Group, Inc. 2010 - October 2011
PharmaNet Development Group, Inc. 1998 - 2010
Covance 1992 - 1998
Bristol-Myers Squibb, Princeton, New Jersey 1980 - 1992
Skills
Clinical Development, CTMS, Clinical Research, Clinical Trials, Pharmaceutical Industry, Biotechnology, CRO, GCP, Oncology, Drug Development, FDA, Lifesciences, Therapeutic Areas, Regulatory Affairs, Infectious Diseases, EDC, Regulatory Submissions, Biopharmaceuticals, ICH-GCP, Immunology, Drug Discovery, Clinical Data Management, Protocol, Pharmacovigilance, Pharmacology, Neurology, Cardiology, Medical Writing, Sop, Vaccines, Clinical Monitoring, IND, Medical Affairs, Clinical Operations, Validation, GLP
Education
Tufts University School of Medicine 1970 — 1974
M.D.
Cornell University 1966 — 1970
A.B., biology
Ashley Stiles Ashley Stiles's PharmaNet Development Group, Inc. Experience July 2010 - February 2012
Job Project Manager, eClinical, ePRO at Bracket
Industry Pharmaceuticals
Experience
Bracket July 2015 - Present
Bracket August 2014 - Present
Bracket October 2012 - July 2014
ICON plc April 2012 - June 2012
PharmaNet/i3 January 2011 - April 2012
PharmaNet Development Group, Inc. July 2010 - February 2012
PharmaNet Development Group, Inc. February 2009 - June 2010
PharmaNet Development Group, Inc. November 2008 - February 2010
PharmaNet Development Group, Inc. October 2006 - November 2008
PharmaNet Development Group, Inc. January 2006 - October 2006
Skills
CRO, Clinical Data Management, EDC, Clinical Trials, GCP, Oracle Clinical, Sop, CTMS, Oncology, ICH-GCP, Data Management, Pharmaceutical Industry, Clinical Research, Regulatory Submissions, FDA, 21 CFR Part 11, Validation, Clinical Development, Protocol, Clinical Monitoring, Software Documentation, Computer System..., Project Management, SOP
Education
Burlington County College 2001 — 2004
Associate of Science (A.S.), Physcology
Bracket July 2015 - Present
Bracket August 2014 - Present
Bracket October 2012 - July 2014
ICON plc April 2012 - June 2012
PharmaNet/i3 January 2011 - April 2012
PharmaNet Development Group, Inc. July 2010 - February 2012
PharmaNet Development Group, Inc. February 2009 - June 2010
PharmaNet Development Group, Inc. November 2008 - February 2010
PharmaNet Development Group, Inc. October 2006 - November 2008
PharmaNet Development Group, Inc. January 2006 - October 2006
Skills
CRO, Clinical Data Management, EDC, Clinical Trials, GCP, Oracle Clinical, Sop, CTMS, Oncology, ICH-GCP, Data Management, Pharmaceutical Industry, Clinical Research, Regulatory Submissions, FDA, 21 CFR Part 11, Validation, Clinical Development, Protocol, Clinical Monitoring, Software Documentation, Computer System..., Project Management, SOP
Education
Burlington County College 2001 — 2004
Associate of Science (A.S.), Physcology
Michael Schmitt Michael Schmitt's PharmaNet Development Group, Inc. Experience July 2008 - June 2011
Job Corporate Controller
Industry Pharmaceuticals
Experience
Heritage Pharmaceuticals Inc. January 2015 - Present
Dialogic July 2012 - January 2015
Dialogic June 2013 - March 2014
PharmaNet/i3 June 2011 - July 2012
Pharmanet Development Group, Inc. July 2008 - June 2011
PharmaNet Development Group, Inc. June 2007 - June 2008
KPMG LLP June 2002 - June 2007
Arthur Andersen September 2000 - June 2002
Skills
Financial Reporting, Auditing, SEC filings, Consolidation, US GAAP, Cash Flow, General Ledger, Financial Statements, Accounting, Internal Controls, Revenue Recognition, Financial Accounting, GAAP, Big 4, External Audit, Cost Accounting, SOX 404, Variance Analysis, Managerial Finance, Account Reconciliation, Statutory Accounting, Personnel Management, Financial Audits, Consolidated Financial..., Due Diligence, Finance, Financial Analysis
Education
Monmouth University 1996 — 2000
BSBA, Accounting
Heritage Pharmaceuticals Inc. January 2015 - Present
Dialogic July 2012 - January 2015
Dialogic June 2013 - March 2014
PharmaNet/i3 June 2011 - July 2012
Pharmanet Development Group, Inc. July 2008 - June 2011
PharmaNet Development Group, Inc. June 2007 - June 2008
KPMG LLP June 2002 - June 2007
Arthur Andersen September 2000 - June 2002
Skills
Financial Reporting, Auditing, SEC filings, Consolidation, US GAAP, Cash Flow, General Ledger, Financial Statements, Accounting, Internal Controls, Revenue Recognition, Financial Accounting, GAAP, Big 4, External Audit, Cost Accounting, SOX 404, Variance Analysis, Managerial Finance, Account Reconciliation, Statutory Accounting, Personnel Management, Financial Audits, Consolidated Financial..., Due Diligence, Finance, Financial Analysis
Education
Monmouth University 1996 — 2000
BSBA, Accounting
Jason Allen Williams Jason Allen Williams's PharmaNet Development Group, Inc. Experience July 2002 - August 2007
Job Chief Financial Officer at ForceField Energy Inc.
Industry Accounting
Experience
ForceField Energy Inc. October 2011 - Present
WM Consulting, LLC August 2010 - Present
Protective Products Enterprises, Inc. August 2007 - August 2010
PharmaNet Development Group, Inc. July 2002 - August 2007
Patagon.com October 2001 - August 2002
vFinance, Inc July 2001 - October 2001
BISYS Professional Services September 1995 - July 2001
Skills
Accounting, Acquisitions, Compliance, Corporate Finance, Corporate Governance, Financial Analysis, Financial Modeling, Financial Reporting, FINRA, Investor Relations, Mergers, SEC filings, Strategic Planning, Treasury Management, Mergers & Acquisitions, Due Diligence, Finance, Forecasting, Management, SEC Filings, Start-ups
Education
Florida Atlantic University 1991 — 1995
BS, Accounting
ForceField Energy Inc. October 2011 - Present
WM Consulting, LLC August 2010 - Present
Protective Products Enterprises, Inc. August 2007 - August 2010
PharmaNet Development Group, Inc. July 2002 - August 2007
Patagon.com October 2001 - August 2002
vFinance, Inc July 2001 - October 2001
BISYS Professional Services September 1995 - July 2001
Skills
Accounting, Acquisitions, Compliance, Corporate Finance, Corporate Governance, Financial Analysis, Financial Modeling, Financial Reporting, FINRA, Investor Relations, Mergers, SEC filings, Strategic Planning, Treasury Management, Mergers & Acquisitions, Due Diligence, Finance, Forecasting, Management, SEC Filings, Start-ups
Education
Florida Atlantic University 1991 — 1995
BS, Accounting
Russell Royzman, MBA Russell Royzman, MBA's PharmaNet Development Group, Inc. Experience December 2009 - May 2011
Job Experienced Finance Professional
Industry Financial Services
Experience
Freedom Mortgage March 2014 - Present
WyzAnt Tutoring February 2011 - Present
Celerion May 2011 - October 2013
PharmaNet Development Group, Inc. December 2009 - May 2011
PharmaNet Development Group, Inc. May 2009 - December 2009
Gezign LLC November 2008 - May 2009
Yellow Book USA April 2006 - November 2008
GE March 2004 - April 2006
Hay Group April 2003 - November 2003
RCN March 2000 - December 2002
Skills
Budgeting, Forecasting, Financial Modeling, Financial Analysis, Excel, CRO, PowerPoint, Microsoft Office, Microsoft Excel, Analysis, Cross-functional Team..., Budgets, Accounting, Training, Management, Process Improvement, Leadership
Education
Northeastern University 2011 — 2013
MBA, Finance, 3.8
Temple University - Fox School of Business and Management 1995 — 1999
Bachelor of Business Administration (BBA), Finance & Economics, 3.3
Freedom Mortgage March 2014 - Present
WyzAnt Tutoring February 2011 - Present
Celerion May 2011 - October 2013
PharmaNet Development Group, Inc. December 2009 - May 2011
PharmaNet Development Group, Inc. May 2009 - December 2009
Gezign LLC November 2008 - May 2009
Yellow Book USA April 2006 - November 2008
GE March 2004 - April 2006
Hay Group April 2003 - November 2003
RCN March 2000 - December 2002
Skills
Budgeting, Forecasting, Financial Modeling, Financial Analysis, Excel, CRO, PowerPoint, Microsoft Office, Microsoft Excel, Analysis, Cross-functional Team..., Budgets, Accounting, Training, Management, Process Improvement, Leadership
Education
Northeastern University 2011 — 2013
MBA, Finance, 3.8
Temple University - Fox School of Business and Management 1995 — 1999
Bachelor of Business Administration (BBA), Finance & Economics, 3.3
Samah Ismail Samah Ismail's PharmaNet Development Group, Inc. Experience September 2006 - January 2012
Job Manager Regulatory Compliance
Industry Pharmaceuticals
Experience
Novartis April 2012 - Present
PharmaNet Development Group, Inc. September 2006 - January 2012
Bristol-Myers Squibb January 2004 - September 2006
sanofi-aventis February 2003 - April 2004
Schering-Plough Pharmaceutical March 2002 - August 2003
Ortho Clinical Diagnostics January 2000 - October 2002
Skills
Computer System..., FDA, CAPA, Clinical Trials, GLP, GCP, GMP, Software Documentation, Quality System, Quality Assurance, Quality Control, Management, CRO, Medical Devices, Pharmaceutical Industry
Education
University of Medicine and Dentistry of New Jersey 2000 — 2006
Master of Science (MS), Biomedical Informatics
Alexandria University
Bachelor of Applied Science (BASc), Biochemistry
Novartis April 2012 - Present
PharmaNet Development Group, Inc. September 2006 - January 2012
Bristol-Myers Squibb January 2004 - September 2006
sanofi-aventis February 2003 - April 2004
Schering-Plough Pharmaceutical March 2002 - August 2003
Ortho Clinical Diagnostics January 2000 - October 2002
Skills
Computer System..., FDA, CAPA, Clinical Trials, GLP, GCP, GMP, Software Documentation, Quality System, Quality Assurance, Quality Control, Management, CRO, Medical Devices, Pharmaceutical Industry
Education
University of Medicine and Dentistry of New Jersey 2000 — 2006
Master of Science (MS), Biomedical Informatics
Alexandria University
Bachelor of Applied Science (BASc), Biochemistry
![James Harmon [LION]](https://cdn.bearsofficialsstore.com/li/webp/69321882.webp)
James Harmon [LION] James Harmon [LION]'s PharmaNet Development Group, Inc. Experience May 2010 - December 2010
Job Study Start Up Associate II at ICON plc
Industry Pharmaceuticals
Experience
ICON plc April 2011 - Present
PharmaNet Development Group, Inc. May 2010 - December 2010
Smith Hanley Consulting Group December 2009 - March 2010
ClinForce February 2008 - April 2009
Smith Hanley Consulting Group May 2007 - December 2007
ClinForce 2006 - 2007
Skills
Clinical Trials, CTMS, Clinical Monitoring, Pharmaceutical Industry, GCP, Regulatory Submissions, Inform, CRO, Clinical Operations, ICH-GCP, SOP, Clinical Research
Education
Drexel University College of Medicine
Clinical Research
University of Redlands
BA
ICON plc April 2011 - Present
PharmaNet Development Group, Inc. May 2010 - December 2010
Smith Hanley Consulting Group December 2009 - March 2010
ClinForce February 2008 - April 2009
Smith Hanley Consulting Group May 2007 - December 2007
ClinForce 2006 - 2007
Skills
Clinical Trials, CTMS, Clinical Monitoring, Pharmaceutical Industry, GCP, Regulatory Submissions, Inform, CRO, Clinical Operations, ICH-GCP, SOP, Clinical Research
Education
Drexel University College of Medicine
Clinical Research
University of Redlands
BA
Mary Brickner Mary Brickner's PharmaNet Development Group, Inc. Experience October 2009 - January 2011
Job Executive/HR Administrative Assistant
Industry Pharmaceuticals
Experience
PharmaNet Resource Solutions February 2011 - January 2012
PharmaNet Development Group, Inc. October 2009 - January 2011
PharmaNet Development Group, Inc. January 2008 - October 2009
PharmaNet Development Group, Inc. October 2006 - January 2008
Action International December 2005 - October 2006
Bank Financial Services 2004 - 2004
Mercer County Community College January 2003 - November 2003
Northwestern Benefit Services 2002 - 2003
Mellon Bank 1983 - 1986
Rockwell International 1979 - 1983
Education
Duquesne University 1981 — 1985
Bachelor of Science, Business Administration; Human Resources Management
Indiana University of Pennsylvania 1971 — 1973
Theatre
PharmaNet Resource Solutions February 2011 - January 2012
PharmaNet Development Group, Inc. October 2009 - January 2011
PharmaNet Development Group, Inc. January 2008 - October 2009
PharmaNet Development Group, Inc. October 2006 - January 2008
Action International December 2005 - October 2006
Bank Financial Services 2004 - 2004
Mercer County Community College January 2003 - November 2003
Northwestern Benefit Services 2002 - 2003
Mellon Bank 1983 - 1986
Rockwell International 1979 - 1983
Education
Duquesne University 1981 — 1985
Bachelor of Science, Business Administration; Human Resources Management
Indiana University of Pennsylvania 1971 — 1973
Theatre
Christopher Cavallaro, MS, CSM Christopher Cavallaro, MS, CSM's PharmaNet Development Group, Inc. Experience August 2002 - August 2003
Job Sr. Project Manager at ACI Clinical
Industry Pharmaceuticals
Experience
ACI Clinical April 2011 - Present
AstraZeneca January 2010 - April 2011
AstraZeneca October 2003 - December 2009
PharmaNet Development Group, Inc. August 2002 - August 2003
PharmaNet Development Group, Inc. October 2001 - August 2002
PharmaNet Development Group, Inc. March 2001 - October 2001
Wyeth Pharmaceuticals October 2000 - March 2001
Skills
Clinical Research, CRO, Clinical Trials, Clinical Data Management, EDC, CTMS, GCP, Clinical Development, Clinical Operations, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, 21 CFR Part 11, Pharmacovigilance, Protocol, Validation, Cardiology, Neuroscience, Computer System..., Data Management, Patient Safety, Regulatory Submissions, Therapeutic Areas, Sop, Drug Development, Cancer, Dermatology, Drug Safety, Patient Recruitment, Certified Scrum Master..., Software Development, SDLC, Test Scripts, User Acceptance Testing, User Requirements, Functional Requirements, Clinical Study Design
Education
Philadelphia College of Osteopathic Medicine 1998 — 2001
MS, Biomedical Sciences
La Salle University 1994 — 1998
BA, Biology
St. Joseph's Prep 1990 — 1994
HS Diploma
ACI Clinical April 2011 - Present
AstraZeneca January 2010 - April 2011
AstraZeneca October 2003 - December 2009
PharmaNet Development Group, Inc. August 2002 - August 2003
PharmaNet Development Group, Inc. October 2001 - August 2002
PharmaNet Development Group, Inc. March 2001 - October 2001
Wyeth Pharmaceuticals October 2000 - March 2001
Skills
Clinical Research, CRO, Clinical Trials, Clinical Data Management, EDC, CTMS, GCP, Clinical Development, Clinical Operations, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, 21 CFR Part 11, Pharmacovigilance, Protocol, Validation, Cardiology, Neuroscience, Computer System..., Data Management, Patient Safety, Regulatory Submissions, Therapeutic Areas, Sop, Drug Development, Cancer, Dermatology, Drug Safety, Patient Recruitment, Certified Scrum Master..., Software Development, SDLC, Test Scripts, User Acceptance Testing, User Requirements, Functional Requirements, Clinical Study Design
Education
Philadelphia College of Osteopathic Medicine 1998 — 2001
MS, Biomedical Sciences
La Salle University 1994 — 1998
BA, Biology
St. Joseph's Prep 1990 — 1994
HS Diploma
Kristen Richardson Kristen Richardson's PharmaNet Development Group, Inc. Experience August 2010 - August 2011
Job Associate Director, Business Development at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical October 2014 - Present
Duke Clinical Research Institute July 2012 - October 2014
PharmaNet/i3 August 2011 - July 2012
PharmaNet Development Group, Inc. August 2010 - August 2011
PharmaNet Development Group, Inc. March 2009 - August 2010
Cato Research September 2006 - March 2009
Island Training Solutions June 2005 - September 2006
Skills
Clinical Trials, Strategy, CRM, Proposal Writing, Analysis, Program Management, Management, Project Management, Business Development, Budgets, CRO, Market Research, Clinical Development, Pharmaceutical Industry, Contract Negotiation, GCP, EDC, Clinical Data Management, Oncology, Biotechnology
Education
Wake Forest University 2001 — 2005
BA, Communication, Statistical Math
Campbell University
Master of Business Administration (MBA)
inVentiv Health Clinical October 2014 - Present
Duke Clinical Research Institute July 2012 - October 2014
PharmaNet/i3 August 2011 - July 2012
PharmaNet Development Group, Inc. August 2010 - August 2011
PharmaNet Development Group, Inc. March 2009 - August 2010
Cato Research September 2006 - March 2009
Island Training Solutions June 2005 - September 2006
Skills
Clinical Trials, Strategy, CRM, Proposal Writing, Analysis, Program Management, Management, Project Management, Business Development, Budgets, CRO, Market Research, Clinical Development, Pharmaceutical Industry, Contract Negotiation, GCP, EDC, Clinical Data Management, Oncology, Biotechnology
Education
Wake Forest University 2001 — 2005
BA, Communication, Statistical Math
Campbell University
Master of Business Administration (MBA)
Liz Dean Liz Dean's PharmaNet Development Group, Inc. Experience August 2009 - August 2011
Job Clinical Research Professional
Industry Pharmaceuticals
Experience
inVentiv Health Clinical July 2015 - Present
Consultant July 2014 - April 2015
PAREXEL August 2012 - June 2014
PharmaNet/i3 April 2012 - August 2012
Kforce Clinical Research, Inc. August 2011 - April 2012
PharmaNet Development Group, Inc. August 2009 - August 2011
Discovery Labs April 2009 - August 2009
Discovery Labs January 2008 - April 2009
MedConference August 2007 - January 2008
Telerx May 2005 - August 2007
Skills
Microsoft Office, Interpersonal..., Team Problem Solving, Multiple Projects..., Open to New Ideas, Relationship Management, Clinical Research, Clinical Site Monitoring, Document Management, ICH-GCP, Regulatory Documentation, TMF, ISF, Drug Accountability, Medical Affairs, CTMS, EDC, Therapeutic Areas, Contract Management, GCP, CRO, Clinical Trials, CRF design, Clinical Monitoring
Education
Penn State University 2001 — 2005
Telecommunications, Communications
inVentiv Health Clinical July 2015 - Present
Consultant July 2014 - April 2015
PAREXEL August 2012 - June 2014
PharmaNet/i3 April 2012 - August 2012
Kforce Clinical Research, Inc. August 2011 - April 2012
PharmaNet Development Group, Inc. August 2009 - August 2011
Discovery Labs April 2009 - August 2009
Discovery Labs January 2008 - April 2009
MedConference August 2007 - January 2008
Telerx May 2005 - August 2007
Skills
Microsoft Office, Interpersonal..., Team Problem Solving, Multiple Projects..., Open to New Ideas, Relationship Management, Clinical Research, Clinical Site Monitoring, Document Management, ICH-GCP, Regulatory Documentation, TMF, ISF, Drug Accountability, Medical Affairs, CTMS, EDC, Therapeutic Areas, Contract Management, GCP, CRO, Clinical Trials, CRF design, Clinical Monitoring
Education
Penn State University 2001 — 2005
Telecommunications, Communications
Robin Cushman Robin Cushman's PharmaNet Development Group, Inc. Experience October 2010 - January 2011
Job Clinical Research Associate at Luitpold Pharmaceuticals
Industry Pharmaceuticals
Experience
Luitpold Pharmaceuticals June 2014 - Present
Phlexglobal June 2013 - March 2014
Astra Zeneca Pharmaceuticals February 2012 - June 2013
Iroko Pharmaceuticals July 2012 - December 2012
Astra Zeneca 2012 - July 2012
PharmaNet Development Group, Inc. October 2010 - January 2011
PSI Pharma Support America December 2007 - March 2010
ICON Clinical Research May 2006 - June 2007
Skills
Clinical Trials, CRO, ICH-GCP, GCP, TMF, Clinical Operations, FDA, CTMS, Oncology, Clinical Monitoring, Pharmaceutical Industry, Clinical Data Management, Clinical Development, Sop, EDC, Clinical Research, Oracle Clinical, Regulatory Submissions, Therapeutic Areas, Protocol, Regulatory Affairs, Pharmacovigilance, Infectious Diseases, Patient Recruitment, Vaccines, SOP
Education
Rosemont College 1995 — 2001
BA, Sociology
Rosemont College 1989 — 1993
Bachelor's degree, Sociology
Luitpold Pharmaceuticals June 2014 - Present
Phlexglobal June 2013 - March 2014
Astra Zeneca Pharmaceuticals February 2012 - June 2013
Iroko Pharmaceuticals July 2012 - December 2012
Astra Zeneca 2012 - July 2012
PharmaNet Development Group, Inc. October 2010 - January 2011
PSI Pharma Support America December 2007 - March 2010
ICON Clinical Research May 2006 - June 2007
Skills
Clinical Trials, CRO, ICH-GCP, GCP, TMF, Clinical Operations, FDA, CTMS, Oncology, Clinical Monitoring, Pharmaceutical Industry, Clinical Data Management, Clinical Development, Sop, EDC, Clinical Research, Oracle Clinical, Regulatory Submissions, Therapeutic Areas, Protocol, Regulatory Affairs, Pharmacovigilance, Infectious Diseases, Patient Recruitment, Vaccines, SOP
Education
Rosemont College 1995 — 2001
BA, Sociology
Rosemont College 1989 — 1993
Bachelor's degree, Sociology
Ram Ranjan Ram Ranjan's PharmaNet Development Group, Inc. Experience May 2000 - January 2012
Job Software Consultant
Industry Pharmaceuticals
Experience
PharmaNet Development Group, Inc. May 2000 - January 2012
Covance March 1999 - April 2000
Skills
SDLC, 21 CFR Part 11, Software Development, Clinical Trials, Oracle, PL/SQL, Software Project..., SQL, Microsoft SQL Server, Database Design
Education
Concordia University
Bs, Computer Science
PharmaNet Development Group, Inc. May 2000 - January 2012
Covance March 1999 - April 2000
Skills
SDLC, 21 CFR Part 11, Software Development, Clinical Trials, Oracle, PL/SQL, Software Project..., SQL, Microsoft SQL Server, Database Design
Education
Concordia University
Bs, Computer Science
Melanie (Stern) Goldstein Melanie (Stern) Goldstein's PharmaNet Development Group, Inc. Experience October 2010 - December 2010
Job Clinical Data Coordinator at Covance
Industry Pharmaceuticals
Experience
Covance April 2013 - Present
Covance August 2011 - April 2013
Merck/ClinForce March 2011 - July 2011
PharmaNet Development Group, Inc. October 2010 - December 2010
American SciTech Research International January 2010 - September 2010
American SciTech Research Institute February 2009 - January 2010
Riverview Medical Center September 1999 - December 2000
Cytogen Corporation September 1996 - November 1998
Children's Hospital Boston September 1986 - August 1993
Skills
Clinical Trials, GCP, CTMS, Oncology, Sop, Protocol, Immunology, Cardiology, Medical Affairs, Pharmaceutical Industry, CRO, CRF design, Clinical Development, Regulatory Affairs, Biotechnology, Clinical Monitoring, Clinical Research, Clinical Data Management, ICH-GCP, EDC, Regulatory Submissions, Pharmacovigilance
Education
American Scitech Research International 2009 — 2009
certificate, Clinical Research Associate
Massachusetts College of Pharmacy and Health Sciences 1995 — 1997
Associates, Nuclear Medicine Technology
Rochester Institute of Technology 1982 — 1984
BS, Biomedical Photography
Covance April 2013 - Present
Covance August 2011 - April 2013
Merck/ClinForce March 2011 - July 2011
PharmaNet Development Group, Inc. October 2010 - December 2010
American SciTech Research International January 2010 - September 2010
American SciTech Research Institute February 2009 - January 2010
Riverview Medical Center September 1999 - December 2000
Cytogen Corporation September 1996 - November 1998
Children's Hospital Boston September 1986 - August 1993
Skills
Clinical Trials, GCP, CTMS, Oncology, Sop, Protocol, Immunology, Cardiology, Medical Affairs, Pharmaceutical Industry, CRO, CRF design, Clinical Development, Regulatory Affairs, Biotechnology, Clinical Monitoring, Clinical Research, Clinical Data Management, ICH-GCP, EDC, Regulatory Submissions, Pharmacovigilance
Education
American Scitech Research International 2009 — 2009
certificate, Clinical Research Associate
Massachusetts College of Pharmacy and Health Sciences 1995 — 1997
Associates, Nuclear Medicine Technology
Rochester Institute of Technology 1982 — 1984
BS, Biomedical Photography
Dan Amato Dan Amato's PharmaNet Development Group, Inc. Experience November 2007 - April 2011
Job Application Support Engineer at TRex Corporation
Industry Pharmaceuticals
Experience
T-Rex Corporation March 2014 - Present
Integra LifeSciences April 2011 - September 2012
PharmaNet Development Group, Inc. November 2007 - April 2011
NRG December 2005 - October 2007
Abbott POC 2004 - 2005
sanofi-aventis August 2002 - November 2004
Bristol-Myers Squibb April 1999 - January 2002
Skills
Leadership, Team Leadership, ITIL, Management, Process Improvement, Vendor Management, Change Management, Quality Assurance, Program Management, Outsourcing, IT Management, Governance, CRM, Integration, Cross-functional Team..., Business Process..., SDLC, Service Delivery, Business Analysis, Business Process, IT Service Management, IT Strategy, PMP, SharePoint, IT Operations, Resource Management, Disaster Recovery
Education
County College of Morris
A.S.
Multnomah Bible College
B.S., Education
Nyack Graduate School
Master's, Academics
PC AGE Computer Training School
T-Rex Corporation March 2014 - Present
Integra LifeSciences April 2011 - September 2012
PharmaNet Development Group, Inc. November 2007 - April 2011
NRG December 2005 - October 2007
Abbott POC 2004 - 2005
sanofi-aventis August 2002 - November 2004
Bristol-Myers Squibb April 1999 - January 2002
Skills
Leadership, Team Leadership, ITIL, Management, Process Improvement, Vendor Management, Change Management, Quality Assurance, Program Management, Outsourcing, IT Management, Governance, CRM, Integration, Cross-functional Team..., Business Process..., SDLC, Service Delivery, Business Analysis, Business Process, IT Service Management, IT Strategy, PMP, SharePoint, IT Operations, Resource Management, Disaster Recovery
Education
County College of Morris
A.S.
Multnomah Bible College
B.S., Education
Nyack Graduate School
Master's, Academics
PC AGE Computer Training School
Maria Fassano, MM, CCDM Maria Fassano, MM, CCDM's PharmaNet Development Group, Inc. Experience February 2006 - March 2011
Job Clinical Informatics Manager at PRA Health Sciences | Pennsylvania Conference for Women Ambassador
Industry Pharmaceuticals
Experience
PRA Health Sciences June 2013 - Present
PRA Health Sciences April 2011 - June 2013
PharmaNet Development Group, Inc. February 2006 - March 2011
PharmaNet Development Group, Inc. May 2004 - February 2006
PharmaNet Development Group, Inc. May 2002 - May 2004
PharmaNet Development Group, Inc. December 2001 - May 2002
PharmaNet Development Group, Inc. May 1999 - December 2001
Recording for the Blind & Dyslexic March 1997 - April 1999
Clarke American September 1990 - March 1996
The Wood Schools July 1989 - September 1990
Skills
Management, Leadership, Mentoring, Budgeting, Budgets, Project Management, Protocol, Pharmaceutical Industry, Clinical Research, Clinical Data Management, Data Management, Clinical Monitoring, CRO, Clinical Trials, ICH-GCP, GCP, 21 CFR Part 11, Sop, EDC, CRF design, Therapeutic Areas, Oncology, Software Documentation, Biomedical Informatics, Oracle Clinical, CTMS, Inform, Data Entry, CDISC, SOP
Education
University of Phoenix 2007 — 2009
Masters, Management
Peirce College 2004 — 2006
BS, Business Administration with a concentration in Management
Thomas Edison State College 2002 — 2004
AS, Business Administration
Bishop Conwell 1985 — 1989
Academic Degree with a concentration in Management/Accounting
PRA Health Sciences June 2013 - Present
PRA Health Sciences April 2011 - June 2013
PharmaNet Development Group, Inc. February 2006 - March 2011
PharmaNet Development Group, Inc. May 2004 - February 2006
PharmaNet Development Group, Inc. May 2002 - May 2004
PharmaNet Development Group, Inc. December 2001 - May 2002
PharmaNet Development Group, Inc. May 1999 - December 2001
Recording for the Blind & Dyslexic March 1997 - April 1999
Clarke American September 1990 - March 1996
The Wood Schools July 1989 - September 1990
Skills
Management, Leadership, Mentoring, Budgeting, Budgets, Project Management, Protocol, Pharmaceutical Industry, Clinical Research, Clinical Data Management, Data Management, Clinical Monitoring, CRO, Clinical Trials, ICH-GCP, GCP, 21 CFR Part 11, Sop, EDC, CRF design, Therapeutic Areas, Oncology, Software Documentation, Biomedical Informatics, Oracle Clinical, CTMS, Inform, Data Entry, CDISC, SOP
Education
University of Phoenix 2007 — 2009
Masters, Management
Peirce College 2004 — 2006
BS, Business Administration with a concentration in Management
Thomas Edison State College 2002 — 2004
AS, Business Administration
Bishop Conwell 1985 — 1989
Academic Degree with a concentration in Management/Accounting
W. Todd Kays, PhD W. Todd Kays, PhD's PharmaNet Development Group, Inc. Experience April 2010 - February 2011
Job Vice President, Biopharmaceutics at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Amneal Pharmaceuticals April 2011 - April 2014
PharmaNet Development Group, Inc. April 2010 - February 2011
Symbio, LLC February 2006 - March 2010
ABD Pharmaceuticals June 2005 - January 2006
Clay-Park Labs, Inc./Agis Industries (now Perrigo) August 2002 - June 2005
Clay-Park Labs/Agis Group November 2000 - August 2002
SFBC/Pharmaceutical Development Associates (now PharmaNet) 1999 - 2000
ClinSites/Pharmaceutical Development Associates 1998 - 1999
National Eye Institute, National Institutes of Health April 1993 - August 1998
Skills
Ophthalmology, Respiration, Pharmaceutical Industry, Clinical Trials, Clinical Development, Regulatory Affairs, GCP, Drug Development, FDA, Regulatory Submissions, CRO, CTMS, IND, Pharmaceutics, Therapeutic Areas, Medical Writing, Clinical Research, Dermatology, ICH-GCP, Protocol, Formulation, Pharmacovigilance, R&D, GLP, Sop, Technology Transfer, Biotechnology, Regulatory Requirements, Drug Delivery, NDA, Pharmacology, Biopharmaceuticals, Generic Programming, 21 CFR Part 11, SOP
Education
University of Virginia School of Medicine 1986 — 1993
Ph.D., Anatomy and Cell Biology
Louisiana State University
M.S., Physiology
University of Richmond 1977 — 1982
B.A., Biology
Amneal Pharmaceuticals April 2011 - April 2014
PharmaNet Development Group, Inc. April 2010 - February 2011
Symbio, LLC February 2006 - March 2010
ABD Pharmaceuticals June 2005 - January 2006
Clay-Park Labs, Inc./Agis Industries (now Perrigo) August 2002 - June 2005
Clay-Park Labs/Agis Group November 2000 - August 2002
SFBC/Pharmaceutical Development Associates (now PharmaNet) 1999 - 2000
ClinSites/Pharmaceutical Development Associates 1998 - 1999
National Eye Institute, National Institutes of Health April 1993 - August 1998
Skills
Ophthalmology, Respiration, Pharmaceutical Industry, Clinical Trials, Clinical Development, Regulatory Affairs, GCP, Drug Development, FDA, Regulatory Submissions, CRO, CTMS, IND, Pharmaceutics, Therapeutic Areas, Medical Writing, Clinical Research, Dermatology, ICH-GCP, Protocol, Formulation, Pharmacovigilance, R&D, GLP, Sop, Technology Transfer, Biotechnology, Regulatory Requirements, Drug Delivery, NDA, Pharmacology, Biopharmaceuticals, Generic Programming, 21 CFR Part 11, SOP
Education
University of Virginia School of Medicine 1986 — 1993
Ph.D., Anatomy and Cell Biology
Louisiana State University
M.S., Physiology
University of Richmond 1977 — 1982
B.A., Biology
Brandon Atkinson Brandon Atkinson's PharmaNet Development Group, Inc. Experience May 2010 - January 2012
Job Senior Project Associate
Industry Pharmaceuticals
Experience
Premier Research May 2014 - Present
Quintiles December 2012 - May 2014
INC Research April 2011 - December 2012
PharmaNet Development Group, Inc. May 2010 - January 2012
Novella Clinical Resourcing August 2009 - December 2009
Abraxis BioScience July 2008 - July 2009
PPD April 2007 - June 2008
PAREXEL February 2005 - March 2007
GlaxoSmithKline August 1999 - January 2004
Skills
Clinical Trials, CTMS, FDA, CRO, Clinical Data Management, Clinical Development, GCP, Oncology, Lifesciences, ICH-GCP, Clinical Research, EDC, Clinical Monitoring, Regulatory Submissions, Protocol, Life Sciences, Pharmaceutical Industry, Therapeutic Areas, Regulatory Affairs, SOP, Biotechnology, Infectious Diseases
Education
North Carolina Central University 1994 — 1997
BA
Premier Research May 2014 - Present
Quintiles December 2012 - May 2014
INC Research April 2011 - December 2012
PharmaNet Development Group, Inc. May 2010 - January 2012
Novella Clinical Resourcing August 2009 - December 2009
Abraxis BioScience July 2008 - July 2009
PPD April 2007 - June 2008
PAREXEL February 2005 - March 2007
GlaxoSmithKline August 1999 - January 2004
Skills
Clinical Trials, CTMS, FDA, CRO, Clinical Data Management, Clinical Development, GCP, Oncology, Lifesciences, ICH-GCP, Clinical Research, EDC, Clinical Monitoring, Regulatory Submissions, Protocol, Life Sciences, Pharmaceutical Industry, Therapeutic Areas, Regulatory Affairs, SOP, Biotechnology, Infectious Diseases
Education
North Carolina Central University 1994 — 1997
BA
Brogden Timothy Brogden Timothy's PharmaNet Development Group, Inc. Experience February 2006 - March 2008
Job Assoc Records Management Specialist 1 IT Operational System Support at Quintiles
Industry Research
Experience
Quintiles September 2013 - Present
Quintiles September 2011 - August 2013
Premier Research April 2010 - September 2011
PharmaNet Development Group, Inc. February 2006 - March 2008
I3 Statprobe September 2004 - January 2006
Quintiles July 2000 - September 2004
Skills
EDC, Oracle Clinical, Clinical Data Management, CRO, Data Management, GCP, ICH-GCP, eTMF, Inform, Fortis, OC RDC, Microsoft Excel, Microsoft Word, Outlook, Automotive Parts, Computer Repair, Software Installation, Basketball Coaching, Service Focused, Therapeutic Areas, Research, Process Improvement, Database Administration, Protocol, Databases, Training, Software Documentation, Quality Assurance, Healthcare, Clinical Research, SharePoint, Data Analysis, FDA, Pharmaceutical Industry, Biotechnology, Microsoft Office, Validation, CRF design, Project Management, Program Management, Management, Clinical Trials, Sop, Troubleshooting, Medidata, Access, Data Entry, 21 CFR Part 11, Data Validation, Leadership
Education
Mycomputercareer.com 2006 — 2007
A+, MCP, MCTS, IT Support and Networking
Campbell University 1983 — 1986
Physical Education
Swansboro High School
Quintiles September 2013 - Present
Quintiles September 2011 - August 2013
Premier Research April 2010 - September 2011
PharmaNet Development Group, Inc. February 2006 - March 2008
I3 Statprobe September 2004 - January 2006
Quintiles July 2000 - September 2004
Skills
EDC, Oracle Clinical, Clinical Data Management, CRO, Data Management, GCP, ICH-GCP, eTMF, Inform, Fortis, OC RDC, Microsoft Excel, Microsoft Word, Outlook, Automotive Parts, Computer Repair, Software Installation, Basketball Coaching, Service Focused, Therapeutic Areas, Research, Process Improvement, Database Administration, Protocol, Databases, Training, Software Documentation, Quality Assurance, Healthcare, Clinical Research, SharePoint, Data Analysis, FDA, Pharmaceutical Industry, Biotechnology, Microsoft Office, Validation, CRF design, Project Management, Program Management, Management, Clinical Trials, Sop, Troubleshooting, Medidata, Access, Data Entry, 21 CFR Part 11, Data Validation, Leadership
Education
Mycomputercareer.com 2006 — 2007
A+, MCP, MCTS, IT Support and Networking
Campbell University 1983 — 1986
Physical Education
Swansboro High School
Ron Weishaar Ron Weishaar's PharmaNet Development Group, Inc. Experience March 2010 - April 2011
Job Executive Vice President, Observational Research and Registries at Continuum Clinical
Industry Pharmaceuticals
Experience
Continuum Clinical July 2014 - Present
J Trotter Research and Consulting February 2014 - June 2014
inVentiv Health Clinical (formerly PharmaNet and PharmaNet/i3) April 2011 - January 2014
PharmaNet Development Group, Inc. March 2010 - April 2011
Omnicare Clinical Research June 2000 - November 2009
Coromed, Inc. (which later became Omnicare Clinical Research) February 1990 - May 2000
Parke-Davis Pharmaceutical Research Division, Warner−Lambert Company April 1980 - January 1990
Huntington Research Institute January 1976 - March 1980
Skills
Regulatory Affairs, CRO, Medical Devices, Clinical Trials, Clinical Development, Drug Development, Clinical Research, Proposal Writing, Therapeutic Areas, CTMS, Biotechnology, Training, Cross-functional Team..., GCP, Pharmaceutical Industry, FDA, EDC, Management, Lifesciences, Drug Discovery, Pharmacology, Oncology
Education
Eastern Michigan University
B.S., Chemistry
University of Arizona
M.A., Chemistry
University of Michigan
Ph.D., Pharmacology
Continuum Clinical July 2014 - Present
J Trotter Research and Consulting February 2014 - June 2014
inVentiv Health Clinical (formerly PharmaNet and PharmaNet/i3) April 2011 - January 2014
PharmaNet Development Group, Inc. March 2010 - April 2011
Omnicare Clinical Research June 2000 - November 2009
Coromed, Inc. (which later became Omnicare Clinical Research) February 1990 - May 2000
Parke-Davis Pharmaceutical Research Division, Warner−Lambert Company April 1980 - January 1990
Huntington Research Institute January 1976 - March 1980
Skills
Regulatory Affairs, CRO, Medical Devices, Clinical Trials, Clinical Development, Drug Development, Clinical Research, Proposal Writing, Therapeutic Areas, CTMS, Biotechnology, Training, Cross-functional Team..., GCP, Pharmaceutical Industry, FDA, EDC, Management, Lifesciences, Drug Discovery, Pharmacology, Oncology
Education
Eastern Michigan University
B.S., Chemistry
University of Arizona
M.A., Chemistry
University of Michigan
Ph.D., Pharmacology
Jodie Sinclair Jodie Sinclair's PharmaNet Development Group, Inc. Experience June 2010 - June 2012
Job Project Leader, Clinical Research at ApoPharma Inc.
Industry Pharmaceuticals
Experience
ApoPharma Inc. January 2014 - Present
ApoPharma Inc. January 2013 - December 2013
PharmaNet Development Group, Inc. June 2010 - June 2012
ICON Clinical Research April 2008 - May 2010
Novo Nordisk A/S February 2007 - April 2008
Skills
Osteoarthritis, Diabetology, Clinical Research, Biochemistry, System Monitoring, Clinical Monitoring, ICH-GCP, EDC, CTMS, CRF design, GCP, CRO, Patient Recruitment, Oracle Clinical, Hematology, Clinical Operations, Clinical Data Management, Clinical Trials, Medical Writing, Therapeutic Areas
Education
ICRI, Cranfield University 2005 — 2007
M.Sc in Clinical Research, Clinical Research
Avinashilingam Institute for Home Science and Higher Education for Women 2003 — 2005
U.G.Diploma in Bio-Informatics, Bio-informatics
Avinashilingam Institute for Home Science and Higher Education for Women 2002 — 2005
B.Sc, Biochemistry and Biotechnology
ApoPharma Inc. January 2014 - Present
ApoPharma Inc. January 2013 - December 2013
PharmaNet Development Group, Inc. June 2010 - June 2012
ICON Clinical Research April 2008 - May 2010
Novo Nordisk A/S February 2007 - April 2008
Skills
Osteoarthritis, Diabetology, Clinical Research, Biochemistry, System Monitoring, Clinical Monitoring, ICH-GCP, EDC, CTMS, CRF design, GCP, CRO, Patient Recruitment, Oracle Clinical, Hematology, Clinical Operations, Clinical Data Management, Clinical Trials, Medical Writing, Therapeutic Areas
Education
ICRI, Cranfield University 2005 — 2007
M.Sc in Clinical Research, Clinical Research
Avinashilingam Institute for Home Science and Higher Education for Women 2003 — 2005
U.G.Diploma in Bio-Informatics, Bio-informatics
Avinashilingam Institute for Home Science and Higher Education for Women 2002 — 2005
B.Sc, Biochemistry and Biotechnology
Dora Ding Dora Ding's PharmaNet Development Group, Inc. Experience June 2008 - February 2010
Job Principal Statistician at PharmaNet/i3
Industry Pharmaceuticals
Experience
inVentiv Health Clinical November 2012 - Present
Cato Research March 2010 - November 2012
PharmaNet Development Group, Inc. June 2008 - February 2010
Quintiles May 2005 - June 2008
MedFocus March 2004 - May 2005
MedFocus September 2002 - March 2004
Skills
CRO, Biostatistics, Clinical Trials, CDISC, Clinical Development, EDC, Clinical Data Management, GCP, Clinical Research, Clinical Study Design, Oncology, SAS, SAS programming
Education
University of California, Los Angeles - Fielding School of Public Health 2000 — 2002
MS, Biostatistics
University of California, Los Angeles 1998 — 2000
MS, Human Genetics
Peking University 1992 — 1997
BS, Medicine
inVentiv Health Clinical November 2012 - Present
Cato Research March 2010 - November 2012
PharmaNet Development Group, Inc. June 2008 - February 2010
Quintiles May 2005 - June 2008
MedFocus March 2004 - May 2005
MedFocus September 2002 - March 2004
Skills
CRO, Biostatistics, Clinical Trials, CDISC, Clinical Development, EDC, Clinical Data Management, GCP, Clinical Research, Clinical Study Design, Oncology, SAS, SAS programming
Education
University of California, Los Angeles - Fielding School of Public Health 2000 — 2002
MS, Biostatistics
University of California, Los Angeles 1998 — 2000
MS, Human Genetics
Peking University 1992 — 1997
BS, Medicine
Busa Ponalo, MS, PMP Busa Ponalo, MS, PMP's PharmaNet Development Group, Inc. Experience March 2000 - June 2006
Job IT Project Manager | System Architect | Systems Analyst
Industry Information Technology and Services
Experience
Cato Research April 2013 - Present
PharmaNet/i3 January 2010 - January 2013
PharmaNet/i3 July 2006 - January 2010
PharmaNet Development Group, Inc. March 2000 - June 2006
Quintiles Transnational January 1995 - March 2000
Skills
Data Management, EDC, Sop, CTMS, Databases, Clinical Trials, Software Development, Clinical Data Management, 21 CFR Part 11, SQL, Enterprise Architecture, Testing, System Architecture, Java, GCP, Clinical Research, Clinical Development, Pharmaceutical Industry, Oracle, CRO, CDISC, Crystal Reports, Project Management, JavaScript, SDLC, Integration, Cross-functional Team..., Protocol, Web Applications, Computer System..., Quality Assurance, SOP, SharePoint, Oracle Clinical
Education
North Carolina State University
MS
North Carolina Central University
BSc
Cato Research April 2013 - Present
PharmaNet/i3 January 2010 - January 2013
PharmaNet/i3 July 2006 - January 2010
PharmaNet Development Group, Inc. March 2000 - June 2006
Quintiles Transnational January 1995 - March 2000
Skills
Data Management, EDC, Sop, CTMS, Databases, Clinical Trials, Software Development, Clinical Data Management, 21 CFR Part 11, SQL, Enterprise Architecture, Testing, System Architecture, Java, GCP, Clinical Research, Clinical Development, Pharmaceutical Industry, Oracle, CRO, CDISC, Crystal Reports, Project Management, JavaScript, SDLC, Integration, Cross-functional Team..., Protocol, Web Applications, Computer System..., Quality Assurance, SOP, SharePoint, Oracle Clinical
Education
North Carolina State University
MS
North Carolina Central University
BSc
John Spellman, DC John Spellman, DC's PharmaNet Development Group, Inc. Experience April 2005 - August 2006
Job Senior CRA at PRA International
Industry Research
Experience
PRA International January 2013 - Present
Atlantis Physicians Group January 2012 - Present
Amicus Therapeutics October 2010 - January 2012
Beardsworth Consulting Group January 2007 - February 2010
PharmaNet Development Group, Inc. April 2005 - August 2006
MetPath January 1984 - December 1987
Skills
Oncology, Clinical Research, CRO, CTMS, Clinical Monitoring, GCP, Clinical Trials, Vaccines, Infectious Diseases
Education
New York Chiropractic College 1987 — 1990
DC
Seton Hall University 1979 — 1984
BS, Biology
PRA International January 2013 - Present
Atlantis Physicians Group January 2012 - Present
Amicus Therapeutics October 2010 - January 2012
Beardsworth Consulting Group January 2007 - February 2010
PharmaNet Development Group, Inc. April 2005 - August 2006
MetPath January 1984 - December 1987
Skills
Oncology, Clinical Research, CRO, CTMS, Clinical Monitoring, GCP, Clinical Trials, Vaccines, Infectious Diseases
Education
New York Chiropractic College 1987 — 1990
DC
Seton Hall University 1979 — 1984
BS, Biology
Vijaya Voleti Vijaya Voleti's PharmaNet Development Group, Inc. Experience January 2007 - August 2010
Job IT Consultant
Industry Information Technology and Services
Experience
Princeton Information July 2014 - Present
Good Stripe January 2011 - July 2014
Rutgers University 2011 - 2011
PharmaNet Development Group, Inc. January 2007 - August 2010
Pharmanet April 2006 - December 2006
PharmaNet Development Group, Inc. February 2005 - March 2006
PharmaNet Development Group, Inc. October 2002 - January 2005
PharmaNet Development Group, Inc. September 2000 - September 2002
PharmaNet Development Group, Inc. September 1999 - August 2000
Covance March 1998 - September 1999
Skills
IVRS, IWRS, Clinical Trials, Software Project..., Software Quality..., Business Process..., Vendor Management, SDLC Process, Computer System..., Software Documentation, Business Process..., Lean and Six Sigma, Team Leadership, Cross-functional Team..., Strategic Planning, People Development, Drug Development, Manage Client..., GxPs, SDLC, Requirements Analysis, Quality Assurance, Resource Management, 21 CFR Part 11, Strategy, EDC, Management, Agile Methodologies, Project Management, Validation, Clinical Development, CRO, Data Management, IVR, Pharmaceutical Industry, Biotechnology, Oncology, GCP
Education
Rugers University 2011 — 2011
Certificate, Lean and Six Sigma Green Belt and Black Belt
CE Tech
Advanced Diploma in Computer Programming
New Jersey Institute of Technology
BS, Chemical Engineering
New Jersey Institute of Technology
MS, Environmental Engineering
Princeton Information July 2014 - Present
Good Stripe January 2011 - July 2014
Rutgers University 2011 - 2011
PharmaNet Development Group, Inc. January 2007 - August 2010
Pharmanet April 2006 - December 2006
PharmaNet Development Group, Inc. February 2005 - March 2006
PharmaNet Development Group, Inc. October 2002 - January 2005
PharmaNet Development Group, Inc. September 2000 - September 2002
PharmaNet Development Group, Inc. September 1999 - August 2000
Covance March 1998 - September 1999
Skills
IVRS, IWRS, Clinical Trials, Software Project..., Software Quality..., Business Process..., Vendor Management, SDLC Process, Computer System..., Software Documentation, Business Process..., Lean and Six Sigma, Team Leadership, Cross-functional Team..., Strategic Planning, People Development, Drug Development, Manage Client..., GxPs, SDLC, Requirements Analysis, Quality Assurance, Resource Management, 21 CFR Part 11, Strategy, EDC, Management, Agile Methodologies, Project Management, Validation, Clinical Development, CRO, Data Management, IVR, Pharmaceutical Industry, Biotechnology, Oncology, GCP
Education
Rugers University 2011 — 2011
Certificate, Lean and Six Sigma Green Belt and Black Belt
CE Tech
Advanced Diploma in Computer Programming
New Jersey Institute of Technology
BS, Chemical Engineering
New Jersey Institute of Technology
MS, Environmental Engineering
Apurva Bidja's PharmaNet Development Group, Inc. Experience June 2007 - June 2014
Job Clinical Data Manager at Incyte
Industry Pharmaceuticals
Experience
Incyte June 2014 - Present
PharmaNet Development Group, Inc. June 2007 - June 2014
Centocor June 2006 - June 2007
Skills
Data Analysis, Oracle Clinical, EDC, Data Management, CRF design, Vaccines
Education
West Chester University of Pennsylvania 2007 — 2009
MPH, Master in Public Health
West Chester University of Pennsylvania 2003 — 2007
BSc, Pharmacutical Product Development
HACC, Central Pennsylvania's Community College 2001 — 2003
2003, Life Science
I.C. Gandhi High School
Incyte June 2014 - Present
PharmaNet Development Group, Inc. June 2007 - June 2014
Centocor June 2006 - June 2007
Skills
Data Analysis, Oracle Clinical, EDC, Data Management, CRF design, Vaccines
Education
West Chester University of Pennsylvania 2007 — 2009
MPH, Master in Public Health
West Chester University of Pennsylvania 2003 — 2007
BSc, Pharmacutical Product Development
HACC, Central Pennsylvania's Community College 2001 — 2003
2003, Life Science
I.C. Gandhi High School
Nicholas LaBella Nicholas LaBella's PharmaNet Development Group, Inc. Experience 2001 - 2004
Job NL Consulting Services, LLC
Industry Pharmaceuticals
Experience
NL Consulting Services, LLC 2002 - Present
Insmed, Inc March 2010 - October 2012
Cardiokine 2004 - 2009
PharmaNet Development Group, Inc. 2001 - 2004
Medex Clinical Trial Services 1997 - 2001
Watson Pharmaceuticals 1995 - 1997
Circa Pharmaceuticals 1993 - 1995
Lorex Pharmaceuticals 1986 - 1989
Sandoz Research Institute 1980 - 1986
Skills
CRO, GCP, Regulatory Affairs, Drug Development, Clinical Trials, Clinical Development, Pharmaceutical Industry, cGMP practices
Education
LIU Brooklyn 1978 — 1981
MS
University of Connecticut 1973 — 1978
BS
NL Consulting Services, LLC 2002 - Present
Insmed, Inc March 2010 - October 2012
Cardiokine 2004 - 2009
PharmaNet Development Group, Inc. 2001 - 2004
Medex Clinical Trial Services 1997 - 2001
Watson Pharmaceuticals 1995 - 1997
Circa Pharmaceuticals 1993 - 1995
Lorex Pharmaceuticals 1986 - 1989
Sandoz Research Institute 1980 - 1986
Skills
CRO, GCP, Regulatory Affairs, Drug Development, Clinical Trials, Clinical Development, Pharmaceutical Industry, cGMP practices
Education
LIU Brooklyn 1978 — 1981
MS
University of Connecticut 1973 — 1978
BS
Allison Harper Allison Harper's PharmaNet Development Group, Inc. Experience February 2004 - May 2005
Job President at Harper Clinical Research Services LLC
Industry Pharmaceuticals
Experience
Harper Clinical Research Services LLC November 2012 - Present
Appian International Research February 2011 - December 2013
Angiotech April 2008 - February 2011
Angiotech December 2006 - April 2008
Angiotech May 2005 - December 2006
Various Clerkships June 2005 - November 2005
PharmaNet Development Group, Inc. February 2004 - May 2005
PharmaNet Development Group, Inc. August 2003 - February 2004
PharmaNet Development Group, Inc. January 2003 - July 2003
PharmaNet Development Group, Inc. July 2001 - December 2002
Skills
HIPAA, Team Leadership, Clinical Trials..., Clinical Trials..., ICH/GCP, 21 CFR Parts 11, 50,..., CRO and Sponsor..., Excellent Interpersonal..., Leading by Example, Clinical Development, Clinical Trials, Management, Trial Management, Clinical Research, CRO, Leadership, Drug Development, Clinical Monitoring, 21 CFR Part 11, CTMS, Cardiology, FDA, GCP, Infectious Diseases, Pharmaceutical Industry, Protocol, Sop, CRF design, SOP
Education
University of North Carolina at Chapel Hill 2003 — 2005
PharmD, Pharmacy
University of North Carolina at Chapel Hill 1992 — 1995
BS, Pharmacy
Appalachian State University 1990 — 1992
Pre-pharmacy
Harper Clinical Research Services LLC November 2012 - Present
Appian International Research February 2011 - December 2013
Angiotech April 2008 - February 2011
Angiotech December 2006 - April 2008
Angiotech May 2005 - December 2006
Various Clerkships June 2005 - November 2005
PharmaNet Development Group, Inc. February 2004 - May 2005
PharmaNet Development Group, Inc. August 2003 - February 2004
PharmaNet Development Group, Inc. January 2003 - July 2003
PharmaNet Development Group, Inc. July 2001 - December 2002
Skills
HIPAA, Team Leadership, Clinical Trials..., Clinical Trials..., ICH/GCP, 21 CFR Parts 11, 50,..., CRO and Sponsor..., Excellent Interpersonal..., Leading by Example, Clinical Development, Clinical Trials, Management, Trial Management, Clinical Research, CRO, Leadership, Drug Development, Clinical Monitoring, 21 CFR Part 11, CTMS, Cardiology, FDA, GCP, Infectious Diseases, Pharmaceutical Industry, Protocol, Sop, CRF design, SOP
Education
University of North Carolina at Chapel Hill 2003 — 2005
PharmD, Pharmacy
University of North Carolina at Chapel Hill 1992 — 1995
BS, Pharmacy
Appalachian State University 1990 — 1992
Pre-pharmacy
David Hauser's PharmaNet Development Group, Inc. Experience 1998 - 2002
Job High School Science Teacher
Industry Education Management
Experience
Princeton International School of Math and Science July 2014 - Present
The Pennington School August 2013 - June 2014
The Pennington School August 2009 - July 2013
NovaQuest (Quintiles) 2004 - 2008
Discovery Laboratories 2002 - 2004
PharmaNet Development Group, Inc. 1998 - 2002
Education
Cardiff University / Prifysgol Caerdydd 1993 — 1996
PhD, Medical Bioscience
University of Pennsylvania 1990 — 1993
M.A. Biology, Evolutionary Biology
San Diego State University-California State University 1984 — 1987
Bachelor of Science (BSc), Zoology/Animal Biology
Princeton International School of Math and Science July 2014 - Present
The Pennington School August 2013 - June 2014
The Pennington School August 2009 - July 2013
NovaQuest (Quintiles) 2004 - 2008
Discovery Laboratories 2002 - 2004
PharmaNet Development Group, Inc. 1998 - 2002
Education
Cardiff University / Prifysgol Caerdydd 1993 — 1996
PhD, Medical Bioscience
University of Pennsylvania 1990 — 1993
M.A. Biology, Evolutionary Biology
San Diego State University-California State University 1984 — 1987
Bachelor of Science (BSc), Zoology/Animal Biology
Anna Calamita Anna Calamita's PharmaNet Development Group, Inc. Experience June 2010 - March 2011
Job HR Vital Capabilities Design Manager at Johnson & Johnson
Industry Pharmaceuticals
Experience
Johnson & Johnson January 2015 - Present
Johnson & Johnson January 2014 - January 2015
PharmaNet/i3 April 2012 - January 2014
PharmaNet/i3 April 2011 - March 2012
PharmaNet Development Group, Inc. June 2010 - March 2011
PharmaNet Development Group, Inc. December 2009 - May 2010
PharmaNet Development Group, Inc. December 2007 - December 2009
Nordstrom February 1996 - December 2007
Community National Bank 1988 - 1990
Skills
Recruiting, HRIS, Human Resources, Business Process..., Management, Employee Relations, Analysis, Performance Management, Leadership, Training, Customer Service, CRM, Personnel Management, Employee Benefits, Onboarding, New Hire Orientations, Software Documentation, Project Management, Time Management, Employment Law, Talent Management, Administration, PeopleSoft, UltiPro, OrgPlus, SuccessFactors
Education
Baruch College, City University of New York (CUNY)
BBA, Finance and Investments, Management
Kingsborough Community College
AAS, Business Administration
Johnson & Johnson January 2015 - Present
Johnson & Johnson January 2014 - January 2015
PharmaNet/i3 April 2012 - January 2014
PharmaNet/i3 April 2011 - March 2012
PharmaNet Development Group, Inc. June 2010 - March 2011
PharmaNet Development Group, Inc. December 2009 - May 2010
PharmaNet Development Group, Inc. December 2007 - December 2009
Nordstrom February 1996 - December 2007
Community National Bank 1988 - 1990
Skills
Recruiting, HRIS, Human Resources, Business Process..., Management, Employee Relations, Analysis, Performance Management, Leadership, Training, Customer Service, CRM, Personnel Management, Employee Benefits, Onboarding, New Hire Orientations, Software Documentation, Project Management, Time Management, Employment Law, Talent Management, Administration, PeopleSoft, UltiPro, OrgPlus, SuccessFactors
Education
Baruch College, City University of New York (CUNY)
BBA, Finance and Investments, Management
Kingsborough Community College
AAS, Business Administration
Christina Corso Christina Corso's PharmaNet Development Group, Inc. Experience November 2009 - November 2010
Job Senior Human Resources Representative at Roche
Industry Human Resources
Experience
Roche Molecular Systems June 2015 - Present
PVH Corp. October 2014 - June 2015
PVH Corp June 2012 - October 2014
PVH Corp. November 2010 - June 2012
PharmaNet Development Group, Inc. November 2009 - November 2010
BJK Entertainment October 2004 - October 2009
First Investors Corporation December 2008 - May 2009
Skills
Recruiting, Human Resources, Onboarding, HRIS, Employee Relations, Employee Benefits, Talent Management, Applicant Tracking..., Talent Acquisition, Sourcing, College Recruiting, Benefits Administration, PeopleSoft, Interviews, New Hire Orientations, Performance Management, HR Policies, Succession Planning, Employee Engagement, FMLA, Leadership
Education
University of Scranton 2011 — 2015
Master's Degree, Human Resources Management
Rider University 2005 — 2009
Bachelor of Science Business Administration, Human Resources
Roche Molecular Systems June 2015 - Present
PVH Corp. October 2014 - June 2015
PVH Corp June 2012 - October 2014
PVH Corp. November 2010 - June 2012
PharmaNet Development Group, Inc. November 2009 - November 2010
BJK Entertainment October 2004 - October 2009
First Investors Corporation December 2008 - May 2009
Skills
Recruiting, Human Resources, Onboarding, HRIS, Employee Relations, Employee Benefits, Talent Management, Applicant Tracking..., Talent Acquisition, Sourcing, College Recruiting, Benefits Administration, PeopleSoft, Interviews, New Hire Orientations, Performance Management, HR Policies, Succession Planning, Employee Engagement, FMLA, Leadership
Education
University of Scranton 2011 — 2015
Master's Degree, Human Resources Management
Rider University 2005 — 2009
Bachelor of Science Business Administration, Human Resources
Alison Espinoza's PharmaNet Development Group, Inc. Experience May 2010 - December 2010
Job Real Estate Broker
Industry Real Estate
Experience
Phelps Realty December 2013 - Present
Only Way Realty, LLC April 2013 - December 2013
PharmaNet Development Group, Inc. May 2010 - December 2010
Vistakon March 2010 - June 2010
Centocor August 2003 - October 2009
Morphotek, Inc. January 2007 - December 2007
Johnson & Johnson September 2005 - September 2006
Santarus, Inc. May 2003 - August 2003
FeRx, Inc. August 2002 - February 2003
Centocor April 2001 - August 2002
Skills
Clinical Research, Clinical Monitoring, GCP, CTMS, EDC, CRO, Clinical Development, ICH-GCP, Clinical Trials, Clinical Data Management, Oncology, Biotechnology, Quality Assurance, Pharmaceutical Industry, Therapeutic Areas, Sop, Infectious Diseases, Regulatory Submissions, Drug Development
Education
Penn State University 1995 — 1999
B.S., Biotechnology
Phelps Realty December 2013 - Present
Only Way Realty, LLC April 2013 - December 2013
PharmaNet Development Group, Inc. May 2010 - December 2010
Vistakon March 2010 - June 2010
Centocor August 2003 - October 2009
Morphotek, Inc. January 2007 - December 2007
Johnson & Johnson September 2005 - September 2006
Santarus, Inc. May 2003 - August 2003
FeRx, Inc. August 2002 - February 2003
Centocor April 2001 - August 2002
Skills
Clinical Research, Clinical Monitoring, GCP, CTMS, EDC, CRO, Clinical Development, ICH-GCP, Clinical Trials, Clinical Data Management, Oncology, Biotechnology, Quality Assurance, Pharmaceutical Industry, Therapeutic Areas, Sop, Infectious Diseases, Regulatory Submissions, Drug Development
Education
Penn State University 1995 — 1999
B.S., Biotechnology
Syamala Schoemperlen Syamala Schoemperlen's PharmaNet Development Group, Inc. Experience January 2004 - July 2007
Job Head, Statistical Programming at Alcon, a Novartis company
Industry Pharmaceuticals
Experience
Alcon, a Novartis company January 2014 - Present
PharmaSUG 2008 - Present
ICON Clinical Research July 2007 - January 2014
ICON Clinical Research July 2007 - March 2012
PharmaSUG 2009 - 2009
PharmaNet Development Group, Inc. January 2004 - July 2007
PharmaNet Development Group, Inc. June 2001 - January 2004
PharmaNet Development Group, Inc. June 2000 - June 2001
Quintiles, Inc April 2000 - June 2000
Quintiles November 1998 - April 2000
Skills
CDISC, Statistics, Drug Development, SAS programming, CRO, Biostatistics, SAS, Clinical Trials, Data Management, EDC, Clinical Data Management, Pharmaceutical Industry, Clinical Development, Databases, Statistical Programming, Programming, Clinical Research, SDTM, FDA, Biotechnology, Protocol, Oncology, Therapeutic Areas, GCP, Sop, CTMS, Clinical Study Design, ICH-GCP, Regulatory Submissions, 21 CFR Part 11, Inform, Regulatory Affairs, Pharmacovigilance, Validation, Lifesciences, Infectious Diseases, Vaccines, Cardiology, Medical Writing, Oracle Clinical, Data Validation, SAS Programming, SOP
Education
North Carolina State University 1990 — 1992
M.S., Applied Mathematics with Minor in Statistics
Andhra Christian College, Guntur, Andhra Pradesh
B.A., Mathematics, Economics, and Political Sciences
North Carolina State University
B.S., Mathematics
Alcon, a Novartis company January 2014 - Present
PharmaSUG 2008 - Present
ICON Clinical Research July 2007 - January 2014
ICON Clinical Research July 2007 - March 2012
PharmaSUG 2009 - 2009
PharmaNet Development Group, Inc. January 2004 - July 2007
PharmaNet Development Group, Inc. June 2001 - January 2004
PharmaNet Development Group, Inc. June 2000 - June 2001
Quintiles, Inc April 2000 - June 2000
Quintiles November 1998 - April 2000
Skills
CDISC, Statistics, Drug Development, SAS programming, CRO, Biostatistics, SAS, Clinical Trials, Data Management, EDC, Clinical Data Management, Pharmaceutical Industry, Clinical Development, Databases, Statistical Programming, Programming, Clinical Research, SDTM, FDA, Biotechnology, Protocol, Oncology, Therapeutic Areas, GCP, Sop, CTMS, Clinical Study Design, ICH-GCP, Regulatory Submissions, 21 CFR Part 11, Inform, Regulatory Affairs, Pharmacovigilance, Validation, Lifesciences, Infectious Diseases, Vaccines, Cardiology, Medical Writing, Oracle Clinical, Data Validation, SAS Programming, SOP
Education
North Carolina State University 1990 — 1992
M.S., Applied Mathematics with Minor in Statistics
Andhra Christian College, Guntur, Andhra Pradesh
B.A., Mathematics, Economics, and Political Sciences
North Carolina State University
B.S., Mathematics
Sabrina Peterson Sabrina Peterson's PharmaNet Development Group, Inc. Experience November 2010 - November 2011
Job Accounting Specialist 2 at PRA Health Sciences
Industry Accounting
Experience
PRA Health Sciences June 2012 - Present
Lumeta Corporation November 2011 - June 2012
PharmaNet Development Group, Inc. November 2010 - November 2011
Ajilon Finance Solutions June 2009 - July 2010
Sills Cummis & Gross P.C. March 2007 - November 2008
Skills
Accounts Payable, Accounting, Accounts Receivable, Time Management, General Ledger, Spreadsheets, Bookkeeping, Cash Flow, Retail, Journal Entries, Telephone Skills, Outlook, Financial Analysis, Budgets, Microsoft Office, Microsoft Excel, Training, Analysis, Account Reconciliation, Microsoft Word, Invoicing
Education
Ramapo College of New Jersey 2002 — 2007
Bachelors, Business Administration with a concentration in Finance
PRA Health Sciences June 2012 - Present
Lumeta Corporation November 2011 - June 2012
PharmaNet Development Group, Inc. November 2010 - November 2011
Ajilon Finance Solutions June 2009 - July 2010
Sills Cummis & Gross P.C. March 2007 - November 2008
Skills
Accounts Payable, Accounting, Accounts Receivable, Time Management, General Ledger, Spreadsheets, Bookkeeping, Cash Flow, Retail, Journal Entries, Telephone Skills, Outlook, Financial Analysis, Budgets, Microsoft Office, Microsoft Excel, Training, Analysis, Account Reconciliation, Microsoft Word, Invoicing
Education
Ramapo College of New Jersey 2002 — 2007
Bachelors, Business Administration with a concentration in Finance
David Natan's PharmaNet Development Group, Inc. Experience 2002 - 2007
Job Chief Executive Officer at ForceField Energy Inc.
Industry Accounting
Experience
ForceField Energy February 2010 - Present
Natan & Associates, LLC. January 2008 - Present
PharmaNet Development Group, Inc. 2002 - 2007
Skills
Financial Reporting, Mergers, Financial Analysis, SEC filings, Corporate Finance, Private Equity, Public Companies
Education
Boston University 1971 — 1975
Bachelor's degree, Economics and Accounting
Boston University
B.A Economics, Economics, Accounting
ForceField Energy February 2010 - Present
Natan & Associates, LLC. January 2008 - Present
PharmaNet Development Group, Inc. 2002 - 2007
Skills
Financial Reporting, Mergers, Financial Analysis, SEC filings, Corporate Finance, Private Equity, Public Companies
Education
Boston University 1971 — 1975
Bachelor's degree, Economics and Accounting
Boston University
B.A Economics, Economics, Accounting
Heather Brooks Heather Brooks's PharmaNet Development Group, Inc. Experience March 2009 - August 2010
Job Biopharma Advocate Providing Global Clinical Development Solutions to West Coast Biopharma
Industry Biotechnology
Experience
Quintiles January 2014 - Present
ICON plc 2011 - December 2013
Charles River Laboratories August 2010 - May 2011
PharmaNet Development Group, Inc. March 2009 - August 2010
Calypte Biomedical October 2007 - November 2008
Oregon Health & Science University June 1998 - October 2007
Skills
Drug Development, Business Development, Clinical Development, Pharmaceutical Industry, Business Planning
Education
Portland State University 1996 — 1998
BS, Psychology
Quintiles January 2014 - Present
ICON plc 2011 - December 2013
Charles River Laboratories August 2010 - May 2011
PharmaNet Development Group, Inc. March 2009 - August 2010
Calypte Biomedical October 2007 - November 2008
Oregon Health & Science University June 1998 - October 2007
Skills
Drug Development, Business Development, Clinical Development, Pharmaceutical Industry, Business Planning
Education
Portland State University 1996 — 1998
BS, Psychology
Nicole (Barlics) Cohen, LPN Nicole (Barlics) Cohen, LPN's PharmaNet Development Group, Inc. Experience August 2004 - December 2011
Job Manager, Pharmacovigilance at UBC
Industry Pharmaceuticals
Experience
UBC - An Express Scripts Company January 2015 - Present
inVentiv Health Clinical, (formally PharmaNet) July 2012 - January 2015
Homecare Assistance of Red Bank September 2011 - September 2012
Covance December 2011 - July 2012
PharmaNet Development Group, Inc. August 2004 - December 2011
PharmaNet November 2008 - November 2009
PharmaNet November 2006 - November 2008
PharmaNet August 2004 - November 2006
Skills
File Management, Inventory Management, Sales, Customer Service, Vendor Relationships, Data Entry, Outlook, Retail, Vendor Management, Training, Pricing, Employee Management, Business Meetings, Leading Meetings, SAE Reconciliation, Data Reconciliation, Project Plans, Microsoft Office, Nursing Care, Health Education, Computer Science, Clinical Trials, Post Market Surveillance, Clinical Research, ARISg, Argus Safety, EDC, Process Improvement, Process Control, Multi Tasking, Quality Control, Pharmacovigilance, Narrative, FDA, GCP, IND, Medical Writing, Oracle Clinical, Protocol Design, Clinical Development, CRO, CTMS, SOP, Pharmaceutical Industry
Education
Brookdale Community College 2012 — 2013
Associate of Science (A.S.) RN, Registered Nursing/Registered Nurse
Middlesex County Vocational & Technical School 2007 — 2010
AAS, Nursing-LPN
DeVry College of Technology 2001 — 2003
AAS, Computer Programming
UBC - An Express Scripts Company January 2015 - Present
inVentiv Health Clinical, (formally PharmaNet) July 2012 - January 2015
Homecare Assistance of Red Bank September 2011 - September 2012
Covance December 2011 - July 2012
PharmaNet Development Group, Inc. August 2004 - December 2011
PharmaNet November 2008 - November 2009
PharmaNet November 2006 - November 2008
PharmaNet August 2004 - November 2006
Skills
File Management, Inventory Management, Sales, Customer Service, Vendor Relationships, Data Entry, Outlook, Retail, Vendor Management, Training, Pricing, Employee Management, Business Meetings, Leading Meetings, SAE Reconciliation, Data Reconciliation, Project Plans, Microsoft Office, Nursing Care, Health Education, Computer Science, Clinical Trials, Post Market Surveillance, Clinical Research, ARISg, Argus Safety, EDC, Process Improvement, Process Control, Multi Tasking, Quality Control, Pharmacovigilance, Narrative, FDA, GCP, IND, Medical Writing, Oracle Clinical, Protocol Design, Clinical Development, CRO, CTMS, SOP, Pharmaceutical Industry
Education
Brookdale Community College 2012 — 2013
Associate of Science (A.S.) RN, Registered Nursing/Registered Nurse
Middlesex County Vocational & Technical School 2007 — 2010
AAS, Nursing-LPN
DeVry College of Technology 2001 — 2003
AAS, Computer Programming
Christopher Brennan Christopher Brennan's PharmaNet Development Group, Inc. Experience September 2009 - March 2012
Job Senior Vice President & General Counsel at NBTY
Industry Consumer Goods
Experience
NBTY March 2012 - Present
PharmaNet Development Group, Inc. September 2009 - March 2012
Quinnova Pharmaceuticals Inc August 2005 - August 2009
Cravath, Swaine & Moore LLP / Dechert LLP September 2000 - August 2005
Skills
Mergers, Corporate Law, Corporate Governance, Intellectual Property, Contract Negotiation, Licensing, Compliance, Joint Ventures, Securities, Private Equity, Securities Law, Corporate Finance, International Law, Negotiation, Due Diligence, Employment Law, FCPA, Legal Writing, Mergers, Pharmaceutical Industry, Privacy Law, Regulatory Affairs, Securities Regulation
Education
Fordham University School of Law 1997 — 2000
Juris Doctorate, Law
Syracuse University 1993 — 1995
MSSc.
Fordham University 1988 — 1992
Bachelor of Arts
NBTY March 2012 - Present
PharmaNet Development Group, Inc. September 2009 - March 2012
Quinnova Pharmaceuticals Inc August 2005 - August 2009
Cravath, Swaine & Moore LLP / Dechert LLP September 2000 - August 2005
Skills
Mergers, Corporate Law, Corporate Governance, Intellectual Property, Contract Negotiation, Licensing, Compliance, Joint Ventures, Securities, Private Equity, Securities Law, Corporate Finance, International Law, Negotiation, Due Diligence, Employment Law, FCPA, Legal Writing, Mergers, Pharmaceutical Industry, Privacy Law, Regulatory Affairs, Securities Regulation
Education
Fordham University School of Law 1997 — 2000
Juris Doctorate, Law
Syracuse University 1993 — 1995
MSSc.
Fordham University 1988 — 1992
Bachelor of Arts
Richard J. Lazauskas, DC Richard J. Lazauskas, DC's PharmaNet Development Group, Inc. Experience November 2004 - January 2007
Job Associate Director Clinical Operations at Amicus Therapeutics
Industry Pharmaceuticals
Experience
Amicus Therapeutics January 2013 - Present
Amicus Therapeutics October 2008 - December 2012
Amicus Therapeutics January 2007 - October 2008
PharmaNet Development Group, Inc. November 2004 - January 2007
Skills
Clinical Development, CTMS, Clinical Trials, CRO, GCP, EDC, ICH-GCP, Oncology, IND, Regulatory Submissions, Biotechnology, Pharmaceutical Industry, Clinical Monitoring, Clinical Research, Pharmacovigilance, Sop
Education
New York Chiropractic College 1987 — 1990
Doctor of Chiropractic, Chiropractic Medicine
Kean University 1984 — 1987
BA, Biology
Amicus Therapeutics January 2013 - Present
Amicus Therapeutics October 2008 - December 2012
Amicus Therapeutics January 2007 - October 2008
PharmaNet Development Group, Inc. November 2004 - January 2007
Skills
Clinical Development, CTMS, Clinical Trials, CRO, GCP, EDC, ICH-GCP, Oncology, IND, Regulatory Submissions, Biotechnology, Pharmaceutical Industry, Clinical Monitoring, Clinical Research, Pharmacovigilance, Sop
Education
New York Chiropractic College 1987 — 1990
Doctor of Chiropractic, Chiropractic Medicine
Kean University 1984 — 1987
BA, Biology
Shannon David Shannon David's PharmaNet Development Group, Inc. Experience April 2004 - July 2005
Job Director of Corporate Development
Industry Biotechnology
Experience
Waterfront Group July 2005 - Present
Harrison Hayes, LLC December 2010 - October 2012
Adkins Pet Center June 2006 - November 2008
PharmaNet Development Group, Inc. April 2004 - July 2005
Reproductive Endocrinology Associates July 2000 - July 2002
Skills
GCP, FDA, Clinical Research, Lifesciences, Clinical Trials, Analysis, Pharmaceutical Industry, Market Research, Biotechnology, Protocol, Product Launch, Cross-functional Team..., Strategic Planning, Medical Devices, Market Analysis, Business Development, Due Diligence
Education
Mesa Community College 1990 — 1998
EMT-RN, Emergency Medicine
Arizona State University 1990 — 1996
BS, Psychology
Waterfront Group July 2005 - Present
Harrison Hayes, LLC December 2010 - October 2012
Adkins Pet Center June 2006 - November 2008
PharmaNet Development Group, Inc. April 2004 - July 2005
Reproductive Endocrinology Associates July 2000 - July 2002
Skills
GCP, FDA, Clinical Research, Lifesciences, Clinical Trials, Analysis, Pharmaceutical Industry, Market Research, Biotechnology, Protocol, Product Launch, Cross-functional Team..., Strategic Planning, Medical Devices, Market Analysis, Business Development, Due Diligence
Education
Mesa Community College 1990 — 1998
EMT-RN, Emergency Medicine
Arizona State University 1990 — 1996
BS, Psychology
George Tkhinvaleli Ph.D. George Tkhinvaleli Ph.D.'s PharmaNet Development Group, Inc. Experience January 2005 - December 2006
Job GCP/PV QA & QMS Consultant at Nova Eastern GCP Consulting
Industry Pharmaceuticals
Experience
Nova Eastern GCP Consulting August 2015 - Present
Vertex Pharmaceuticals March 2015 - August 2015
Synta Pharmaceuticals September 2014 - March 2015
Pearl Therapeutics (AstraZeneca Group of Companies) May 2011 - September 2014
Forest Laboratories December 2006 - May 2011
PharmaNet Development Group, Inc. January 2005 - December 2006
PAREXEL February 2003 - January 2005
Skills
SOP development, Process Improvement, Gap Analysis, Operational Planning, GCP, Clinical Research, Auditing, Clinical Trials, Pharmaceutical Industry, GxP, 21 CFR Part 11, Regulatory Submissions, Computer System..., Clinical Development, Regulatory Affairs, FDA, CAPA, GLP, Biotechnology, Trackwise, PAI readiness, Six Sigma, IND, Sop, CRO, CTMS, Regulatory Requirements, Clinical Data Management, Quality System, Change Control, SOP, Validation, ICH-GCP, Oncology, Quality Assurance, Drug Development, Therapeutic Areas
Education
Moscow University 1981 — 1987
Master’s Degree, Zoological Engineering
Université catholique de Louvain
Business Management
Russian State Agrarian University - Moscow Timiryazev Agrarian Academy
Doctor of Philosophy (Ph.D.), Biology
Nova Eastern GCP Consulting August 2015 - Present
Vertex Pharmaceuticals March 2015 - August 2015
Synta Pharmaceuticals September 2014 - March 2015
Pearl Therapeutics (AstraZeneca Group of Companies) May 2011 - September 2014
Forest Laboratories December 2006 - May 2011
PharmaNet Development Group, Inc. January 2005 - December 2006
PAREXEL February 2003 - January 2005
Skills
SOP development, Process Improvement, Gap Analysis, Operational Planning, GCP, Clinical Research, Auditing, Clinical Trials, Pharmaceutical Industry, GxP, 21 CFR Part 11, Regulatory Submissions, Computer System..., Clinical Development, Regulatory Affairs, FDA, CAPA, GLP, Biotechnology, Trackwise, PAI readiness, Six Sigma, IND, Sop, CRO, CTMS, Regulatory Requirements, Clinical Data Management, Quality System, Change Control, SOP, Validation, ICH-GCP, Oncology, Quality Assurance, Drug Development, Therapeutic Areas
Education
Moscow University 1981 — 1987
Master’s Degree, Zoological Engineering
Université catholique de Louvain
Business Management
Russian State Agrarian University - Moscow Timiryazev Agrarian Academy
Doctor of Philosophy (Ph.D.), Biology
Steven DiPersio Steven DiPersio's PharmaNet Development Group, Inc. Experience 2007 - 2010
Job Systems Analyst Consultant Bank of America / Merrill Lynch at Icon Information Consultants
Industry Information Technology and Services
Experience
Icon Information Consultants May 2015 - Present
Insight Global February 2015 - Present
Matrix Resources March 2013 - September 2014
Oracle March 2011 - 2013
CBHNP PerformCare an Amerihealth Mercy Company October 2010 - April 2011
PharmaNet Development Group, Inc. 2007 - 2010
PharmaNet Development Group, Inc. 2006 - 2007
PharmaNet Development Group, Inc. 2004 - 2006
MetLife 2001 - 2004
MetLife 2001 - 2004
Skills
SDLC, PL/SQL, Disaster Recovery, Team Building, Mentoring, Risk Management, Stored Procedures, Clinical Trials, Production Support, SQL, SQL Server, Software Development, MS Project, Integration, Team Management, Process Improvement, Requirements Analysis, Team Leadership, Visio, Change Management, Business Intelligence, Programming, Testing, SharePoint, Quality Assurance, Business Analysis, Technical Writing, Resource Management, Microsoft SQL Server, Program Management, Cross-functional Team..., martial arts, Visual Basic, Management, vegan, Fitness, MMA, Black Belt, Leadership, Project Management, Crystal Reports, Troubleshooting, Software Project..., Training, Creative Strategy, Strategy, Vendor Management, Martial Arts, C#, Data Analysis
Education
Rider University 1994 — 1998
B.S., Computer Information Systems, Business
Rider University
BS, Computer Information Systems
Icon Information Consultants May 2015 - Present
Insight Global February 2015 - Present
Matrix Resources March 2013 - September 2014
Oracle March 2011 - 2013
CBHNP PerformCare an Amerihealth Mercy Company October 2010 - April 2011
PharmaNet Development Group, Inc. 2007 - 2010
PharmaNet Development Group, Inc. 2006 - 2007
PharmaNet Development Group, Inc. 2004 - 2006
MetLife 2001 - 2004
MetLife 2001 - 2004
Skills
SDLC, PL/SQL, Disaster Recovery, Team Building, Mentoring, Risk Management, Stored Procedures, Clinical Trials, Production Support, SQL, SQL Server, Software Development, MS Project, Integration, Team Management, Process Improvement, Requirements Analysis, Team Leadership, Visio, Change Management, Business Intelligence, Programming, Testing, SharePoint, Quality Assurance, Business Analysis, Technical Writing, Resource Management, Microsoft SQL Server, Program Management, Cross-functional Team..., martial arts, Visual Basic, Management, vegan, Fitness, MMA, Black Belt, Leadership, Project Management, Crystal Reports, Troubleshooting, Software Project..., Training, Creative Strategy, Strategy, Vendor Management, Martial Arts, C#, Data Analysis
Education
Rider University 1994 — 1998
B.S., Computer Information Systems, Business
Rider University
BS, Computer Information Systems
LaTanya Andrews's PharmaNet Development Group, Inc. Experience December 2009 - March 2010
Job Research Professional
Industry Pharmaceuticals
Experience
UBC - An Express Scripts Company February 2014 - Present
Premier Research January 2013 - June 2014
Premier Research September 2012 - December 2012
ReSearch Pharmaceutical Services April 2011 - September 2012
ReSearch Pharmaceutical Services March 2010 - April 2011
PharmaNet Development Group, Inc. December 2009 - March 2010
PharmaNet/i3 October 2007 - March 2010
Devon Family Practice, LLC January 2004 - March 2007
Skills
Clinical Research, Regulatory Affairs, Pharmaceuticals, GCP, Clinical Trials, FDA, ICH-GCP, Regulatory Submissions, PowerPoint, Word, Excel, Customer Service, Marketing, Self-starter, Business, Entrepreneurship, Training, Sop, Pharmaceutical Industry, Software Documentation
Education
Saint Joseph's University 2010 — 2014
Bachelor, Professional and Liberal Studies, Minor in Health Administration, Junior
Community College of Philadelphia 2007 — 2009
Paralegal Studies, Legal Studies
Cittone Institute 2007 — 2008
Certificate of Pharmacy Technician, Pharmacy
UBC - An Express Scripts Company February 2014 - Present
Premier Research January 2013 - June 2014
Premier Research September 2012 - December 2012
ReSearch Pharmaceutical Services April 2011 - September 2012
ReSearch Pharmaceutical Services March 2010 - April 2011
PharmaNet Development Group, Inc. December 2009 - March 2010
PharmaNet/i3 October 2007 - March 2010
Devon Family Practice, LLC January 2004 - March 2007
Skills
Clinical Research, Regulatory Affairs, Pharmaceuticals, GCP, Clinical Trials, FDA, ICH-GCP, Regulatory Submissions, PowerPoint, Word, Excel, Customer Service, Marketing, Self-starter, Business, Entrepreneurship, Training, Sop, Pharmaceutical Industry, Software Documentation
Education
Saint Joseph's University 2010 — 2014
Bachelor, Professional and Liberal Studies, Minor in Health Administration, Junior
Community College of Philadelphia 2007 — 2009
Paralegal Studies, Legal Studies
Cittone Institute 2007 — 2008
Certificate of Pharmacy Technician, Pharmacy
Emily Mitchell, CCDM Emily Mitchell, CCDM's PharmaNet Development Group, Inc. Experience November 2009 - November 2010
Job Project Manager, Data Optimization
Industry Pharmaceuticals
Experience
PRA Health Sciences August 2015 - Present
PRA Health Sciences September 2014 - August 2015
PRA International August 2013 - September 2014
inVentiv Health Clinical November 2010 - August 2013
PharmaNet Development Group, Inc. November 2009 - November 2010
PharmaNet Development Group, Inc. May 2005 - November 2009
Skills
Clinical Data Management, EDC, Oracle Clinical, GCP, Clinical Trials, Data Collection, CTMS, CDISC, CRO, ICH-GCP, Data Analysis, Therapeutic Areas, Clinical Development, Data Validation, Vaccines, Data Cleaning, SOP development, Inform, Software Project..., 21 CFR Part 11, Pharmaceutical Industry, Medical Coding, Data Entry, Phase I, Oncology, Clinical Research, Biotechnology, Product Development, Late Phase
Education
Penn State University
BSc, Science
PRA Health Sciences August 2015 - Present
PRA Health Sciences September 2014 - August 2015
PRA International August 2013 - September 2014
inVentiv Health Clinical November 2010 - August 2013
PharmaNet Development Group, Inc. November 2009 - November 2010
PharmaNet Development Group, Inc. May 2005 - November 2009
Skills
Clinical Data Management, EDC, Oracle Clinical, GCP, Clinical Trials, Data Collection, CTMS, CDISC, CRO, ICH-GCP, Data Analysis, Therapeutic Areas, Clinical Development, Data Validation, Vaccines, Data Cleaning, SOP development, Inform, Software Project..., 21 CFR Part 11, Pharmaceutical Industry, Medical Coding, Data Entry, Phase I, Oncology, Clinical Research, Biotechnology, Product Development, Late Phase
Education
Penn State University
BSc, Science
Tom Masnaghetti Tom Masnaghetti's PharmaNet Development Group, Inc. Experience May 2011 - August 2011
Job Chief Financial Officer/Exec. VP at Hudson Community Enterprises
Industry Nonprofit Organization Management
Experience
Hudson Community Enterprises July 2012 - Present
Hudson Community Enterprises September 2011 - July 2012
PharmaNet Development Group, Inc. May 2011 - August 2011
inVentiv Health January 2007 - December 2010
inVentiv Health October 2005 - January 2007
inVentiv Health - Franklin Group December 2004 - October 2005
Mobius Investments December 1989 - December 2004
Skills
Strategic Financial..., Forecasting, Financial Reporting, Financial Analysis, Budgets, Process Improvement, Accounting, Corporate Finance, Strategic Planning, Mergers, Business Planning, Auditing, Mergers & Acquisitions, Financial Accounting, Due Diligence, Operations Management, Cash Management, Cash Flow, Risk Management, Coaching, Internal Audit, Leadership, Access, Payroll, Finance, Accounts Payable, Strategy, Executive Management, Analysis, Sarbanes-Oxley Act, General Ledger, Management, Human Resources, Business Process, Financial Statements, Managerial Finance, Financial Modeling, Financial Forecasting, Analytics, Cost Accounting, Consolidation, Internal Controls, Variance Analysis, Pricing, US GAAP, Valuation
Education
California State University-Hayward - School of Business and Economics 1978 — 1981
MBA, Finance
California State University-East Bay 1972 — 1977
BS, Business Administration
Hudson Community Enterprises July 2012 - Present
Hudson Community Enterprises September 2011 - July 2012
PharmaNet Development Group, Inc. May 2011 - August 2011
inVentiv Health January 2007 - December 2010
inVentiv Health October 2005 - January 2007
inVentiv Health - Franklin Group December 2004 - October 2005
Mobius Investments December 1989 - December 2004
Skills
Strategic Financial..., Forecasting, Financial Reporting, Financial Analysis, Budgets, Process Improvement, Accounting, Corporate Finance, Strategic Planning, Mergers, Business Planning, Auditing, Mergers & Acquisitions, Financial Accounting, Due Diligence, Operations Management, Cash Management, Cash Flow, Risk Management, Coaching, Internal Audit, Leadership, Access, Payroll, Finance, Accounts Payable, Strategy, Executive Management, Analysis, Sarbanes-Oxley Act, General Ledger, Management, Human Resources, Business Process, Financial Statements, Managerial Finance, Financial Modeling, Financial Forecasting, Analytics, Cost Accounting, Consolidation, Internal Controls, Variance Analysis, Pricing, US GAAP, Valuation
Education
California State University-Hayward - School of Business and Economics 1978 — 1981
MBA, Finance
California State University-East Bay 1972 — 1977
BS, Business Administration
Bill O'Mara Bill O'Mara's PharmaNet Development Group, Inc. Experience 2005 - 2006
Job Independent Clinical Data Management Consultant
Industry Biotechnology
Experience
DATATRAK International, Inc. November 2010 - November 2013
Gilead Sciences January 2009 - October 2010
Gilead Sciences 2006 - 2008
PharmaNet Development Group, Inc. 2005 - 2006
PharmaNet December 2001 - 2006
Bristol-Myers Squibb May 2001 - November 2001
Quintiles March 2000 - May 2001
Skills
Clinical Research, CRF design, Biostatistics, EDC, CDISC, Clinical Trials, Data Management, CRO, GCP, Oncology, Oracle Clinical, Clinical Development, Validation, CTMS
Education
East Carolina University 1995 — 1999
Bachelor's of Science, Exercise and Sport Sciences
DATATRAK International, Inc. November 2010 - November 2013
Gilead Sciences January 2009 - October 2010
Gilead Sciences 2006 - 2008
PharmaNet Development Group, Inc. 2005 - 2006
PharmaNet December 2001 - 2006
Bristol-Myers Squibb May 2001 - November 2001
Quintiles March 2000 - May 2001
Skills
Clinical Research, CRF design, Biostatistics, EDC, CDISC, Clinical Trials, Data Management, CRO, GCP, Oncology, Oracle Clinical, Clinical Development, Validation, CTMS
Education
East Carolina University 1995 — 1999
Bachelor's of Science, Exercise and Sport Sciences
David Fenske's PharmaNet Development Group, Inc. Experience December 2009 - May 2010
Job
Industry Pharmaceuticals
Experience
DFF Consulting, LLC June 2010 - Present
PharmaNet Development Group, Inc. December 2009 - May 2010
Novartis January 2009 - November 2009
MDS Pharma Services April 2008 - January 2009
ICON Clinical Research April 2006 - April 2008
ICON Clinical Research February 2004 - April 2006
ICON Clinical Research May 2002 - January 2004
PAREXEL GmbH, Berlin Germany February 2000 - May 2002
PAREXEL International April 1999 - April 2001
PAREXEL International January 1997 - April 1999
Skills
Outsourcing, International Management, Financial Control, Contract Negotiation, Proposal Writing, Clinical Research, Clinical Trials, Pharmaceuticals, Strategic Planning, Negotiation, Budgeting, Process Engineering, Pharmaceutical Industry, Cross-functional Team..., CRO, Clinical Development, EDC, Oncology, Project Management, Project Planning, Budgets, Biotechnology, CTMS, Strategy, Regulatory Affairs, Lifesciences, Sop, GCP, FDA, Medical Devices, Infectious Diseases, Vaccines, Life Sciences
Education
Lafayette College 1976 — 1980
BA
DFF Consulting, LLC June 2010 - Present
PharmaNet Development Group, Inc. December 2009 - May 2010
Novartis January 2009 - November 2009
MDS Pharma Services April 2008 - January 2009
ICON Clinical Research April 2006 - April 2008
ICON Clinical Research February 2004 - April 2006
ICON Clinical Research May 2002 - January 2004
PAREXEL GmbH, Berlin Germany February 2000 - May 2002
PAREXEL International April 1999 - April 2001
PAREXEL International January 1997 - April 1999
Skills
Outsourcing, International Management, Financial Control, Contract Negotiation, Proposal Writing, Clinical Research, Clinical Trials, Pharmaceuticals, Strategic Planning, Negotiation, Budgeting, Process Engineering, Pharmaceutical Industry, Cross-functional Team..., CRO, Clinical Development, EDC, Oncology, Project Management, Project Planning, Budgets, Biotechnology, CTMS, Strategy, Regulatory Affairs, Lifesciences, Sop, GCP, FDA, Medical Devices, Infectious Diseases, Vaccines, Life Sciences
Education
Lafayette College 1976 — 1980
BA
Hongyan Xu's PharmaNet Development Group, Inc. Experience October 2010 - November 2014
Job Sr Biostatistician at PPD
Industry Research
Experience
PPD November 2014 - Present
PharmaNet Development Group, Inc. October 2010 - November 2014
Pharmanet Development Group December 2008 - October 2010
Symbiance Inc January 2006 - December 2007
University of Medicine & Dentistry of NJ May 2005 - December 2006
Princeton University April 2002 - June 2003
Dalian Zhongshan General Hospital January 1995 - October 1999
Dalian Merro Pharmaceutical Inc. September 1993 - January 1995
Skills
CRO, Oncology, SAS Programming, Statistics
Education
Rutgers University-New Brunswick 2003 — 2004
MS, Statistics
Liaoning University of Traditional Chinese Medicine 1988 — 1993
MD, Pharmacy
PPD November 2014 - Present
PharmaNet Development Group, Inc. October 2010 - November 2014
Pharmanet Development Group December 2008 - October 2010
Symbiance Inc January 2006 - December 2007
University of Medicine & Dentistry of NJ May 2005 - December 2006
Princeton University April 2002 - June 2003
Dalian Zhongshan General Hospital January 1995 - October 1999
Dalian Merro Pharmaceutical Inc. September 1993 - January 1995
Skills
CRO, Oncology, SAS Programming, Statistics
Education
Rutgers University-New Brunswick 2003 — 2004
MS, Statistics
Liaoning University of Traditional Chinese Medicine 1988 — 1993
MD, Pharmacy
Andrew Chang's PharmaNet Development Group, Inc. Experience June 2006 - November 2010
Job Vice President, Quality and Regulatory Compliance, Product Supply Quality at Novo Nordisk
Industry Pharmaceuticals
Experience
Novo Nordisk September 2014 - Present
Novo Nordisk November 2010 - August 2014
PharmaNet Development Group, Inc. June 2006 - November 2010
FDA CBER, Office of Blood 2002 - 2006
U.S. Department of Health & Human Services 1995 - 2004
Skills
Immunogenicity, Combination Products, Pharmaceutics, Auditing, Drug Development, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, IND, Clinical Trials, Lifesciences, Clinical Development, FDA, GMP, Regulatory Submissions, CRO, Sop, Clinical Research, R&D, Technology Transfer, Biopharmaceuticals, Biochemistry, CMC, Assay Development, GCP, Protein Chemistry, GLP, Biologics, Drug Discovery, Regulatory Requirements, Life Sciences
Education
National Institutes of Health 1991 — 1995
Post-Doc Fellow, Immunology
State University of New York Health Science Center at Brooklyn 1986 — 1991
Ph.D., Biochemistry
China Pharmaceutical University 1978 — 1982
BSc, Pharmaceutical Chemistry
Novo Nordisk September 2014 - Present
Novo Nordisk November 2010 - August 2014
PharmaNet Development Group, Inc. June 2006 - November 2010
FDA CBER, Office of Blood 2002 - 2006
U.S. Department of Health & Human Services 1995 - 2004
Skills
Immunogenicity, Combination Products, Pharmaceutics, Auditing, Drug Development, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, IND, Clinical Trials, Lifesciences, Clinical Development, FDA, GMP, Regulatory Submissions, CRO, Sop, Clinical Research, R&D, Technology Transfer, Biopharmaceuticals, Biochemistry, CMC, Assay Development, GCP, Protein Chemistry, GLP, Biologics, Drug Discovery, Regulatory Requirements, Life Sciences
Education
National Institutes of Health 1991 — 1995
Post-Doc Fellow, Immunology
State University of New York Health Science Center at Brooklyn 1986 — 1991
Ph.D., Biochemistry
China Pharmaceutical University 1978 — 1982
BSc, Pharmaceutical Chemistry
Kelly Rendino's PharmaNet Development Group, Inc. Experience November 2001 - September 2002
Job Local Study Leader at AstraZenece
Industry Pharmaceuticals
Experience
AstraZeneca September 2014 - Present
Theorem Clinical Research January 2014 - September 2014
AstraZeneca October 2011 - December 2013
AstraZeneca April 2007 - February 2012
AstraZeneca September 2003 - April 2007
Hesperion April 2000 - November 2002
PharmaNet Development Group, Inc. November 2001 - September 2002
ICON Clinical Research January 1998 - April 2000
Skills
Clinical Trial..., Clinical Development, Clinical Research, People Management, Change Management, International Project..., CTMS, Clinical Trials, CRO, Management, Leadership, GCP, Cross-functional Team..., Gastroenterology, Pharmaceutical Industry, Clinical Monitoring, Clinical Operations, ICH-GCP, Protocol, Therapeutic Areas
Education
Villanova University 2011 — 2011
Master Certificate in Applied Project Management
Middle Tennessee State University 1996 — 1997
Bachelor of Science (B.S.), Biology/Chemistry
Rutgers University 1993 — 1996
AstraZeneca September 2014 - Present
Theorem Clinical Research January 2014 - September 2014
AstraZeneca October 2011 - December 2013
AstraZeneca April 2007 - February 2012
AstraZeneca September 2003 - April 2007
Hesperion April 2000 - November 2002
PharmaNet Development Group, Inc. November 2001 - September 2002
ICON Clinical Research January 1998 - April 2000
Skills
Clinical Trial..., Clinical Development, Clinical Research, People Management, Change Management, International Project..., CTMS, Clinical Trials, CRO, Management, Leadership, GCP, Cross-functional Team..., Gastroenterology, Pharmaceutical Industry, Clinical Monitoring, Clinical Operations, ICH-GCP, Protocol, Therapeutic Areas
Education
Villanova University 2011 — 2011
Master Certificate in Applied Project Management
Middle Tennessee State University 1996 — 1997
Bachelor of Science (B.S.), Biology/Chemistry
Rutgers University 1993 — 1996
Nan Pham's PharmaNet Development Group, Inc. Experience May 2009 - Present
Job Hospital & Health Care Professional
Industry Hospital & Health Care
Experience
PharmaNet Development Group, Inc. May 2009 - Present
LeMaitre Vascular 2007 - 2009
ArQule 2002 - 2006
Education
MGH Institute of Health Professions 2004 — 2007
PharmaNet Development Group, Inc. May 2009 - Present
LeMaitre Vascular 2007 - 2009
ArQule 2002 - 2006
Education
MGH Institute of Health Professions 2004 — 2007
Jack Van Loon's PharmaNet Development Group, Inc. Experience April 2011 - March 2012
Job Clinical Research ProfessionalConsulting
Industry Pharmaceuticals
Experience
Clinical Research Professional March 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) July 2012 - March 2014
Optimer Pharmaceuticals, Inc. March 2012 - July 2012
PharmaNet Development Group, Inc. April 2011 - March 2012
Biogen Idec, Inc. 2006 - 2011
Quintiles July 1995 - February 2005
Skills
ICH-GCP, Clinical Trials, Regulatory Submissions, Clinical Development, CRO, FDA, Oncology, Drug Development, Lifesciences, Regulatory Affairs, EDC, Clinical Research, Sop, CTMS, Pharmaceutical Industry, GCP
Education
Indiana University-Northwest
Bachelor, Arts & Sciences
Clinical Research Professional March 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) July 2012 - March 2014
Optimer Pharmaceuticals, Inc. March 2012 - July 2012
PharmaNet Development Group, Inc. April 2011 - March 2012
Biogen Idec, Inc. 2006 - 2011
Quintiles July 1995 - February 2005
Skills
ICH-GCP, Clinical Trials, Regulatory Submissions, Clinical Development, CRO, FDA, Oncology, Drug Development, Lifesciences, Regulatory Affairs, EDC, Clinical Research, Sop, CTMS, Pharmaceutical Industry, GCP
Education
Indiana University-Northwest
Bachelor, Arts & Sciences
Ashley McNulty's PharmaNet Development Group, Inc. Experience April 2010 - January 2013
Job Clinical Research Associate at Cato Research
Industry Pharmaceuticals
Experience
Cato Research January 2013 - Present
PharmaNet Development Group, Inc. April 2010 - January 2013
Rite Aid Pharmacy February 2005 - March 2011
Novella Clinical May 2009 - July 2009
Skills
Clinical Trials, ICH-GCP, Pharmaceutical Industry, Clinical Research, EDC, CRO, Lifesciences, Microsoft Office, Sop, Clinical Development, Regulatory Affairs, SOP
Education
Campbell University 2005 — 2009
BSCR, Clinical Research, Minor in Biology
Cato Research January 2013 - Present
PharmaNet Development Group, Inc. April 2010 - January 2013
Rite Aid Pharmacy February 2005 - March 2011
Novella Clinical May 2009 - July 2009
Skills
Clinical Trials, ICH-GCP, Pharmaceutical Industry, Clinical Research, EDC, CRO, Lifesciences, Microsoft Office, Sop, Clinical Development, Regulatory Affairs, SOP
Education
Campbell University 2005 — 2009
BSCR, Clinical Research, Minor in Biology
Devina Forrest's PharmaNet Development Group, Inc. Experience 2004 - 2004
Job Business Development Manager at Almac Clinical Technologies
Industry Pharmaceuticals
Experience
Almac Clinical Technologies October 2008 - Present
PAREXEL September 2004 - October 2008
PharmaNet Development Group, Inc. 2004 - 2004
Quintiles 2003 - 2004
Skills
CRO, Pharmaceutical Industry, Clinical Development, CTMS, Clinical Research, GCP, Biotechnology, Oncology, Sop, Clinical Data Management, Lifesciences, Data Management, Cross-functional Team..., FDA, Regulatory Affairs, Medical Devices, Drug Development, Clinical Trials, EDC, Validation, Pharmacovigilance, Regulatory Submissions, GMP, Pharmaceutics, Infectious Diseases
Education
Rutgers University-New Brunswick 1998 — 2000
M.Ed., English
Howard University 1991 — 1996
Bachelor of Science
Almac Clinical Technologies October 2008 - Present
PAREXEL September 2004 - October 2008
PharmaNet Development Group, Inc. 2004 - 2004
Quintiles 2003 - 2004
Skills
CRO, Pharmaceutical Industry, Clinical Development, CTMS, Clinical Research, GCP, Biotechnology, Oncology, Sop, Clinical Data Management, Lifesciences, Data Management, Cross-functional Team..., FDA, Regulatory Affairs, Medical Devices, Drug Development, Clinical Trials, EDC, Validation, Pharmacovigilance, Regulatory Submissions, GMP, Pharmaceutics, Infectious Diseases
Education
Rutgers University-New Brunswick 1998 — 2000
M.Ed., English
Howard University 1991 — 1996
Bachelor of Science
Collins Owens's PharmaNet Development Group, Inc. Experience January 2008 - October 2009
Job Program Manager at GSK
Industry Pharmaceuticals
Experience
GSK December 2010 - Present
Gilead Sciences November 2009 - January 2011
PharmaNet Development Group, Inc. January 2008 - October 2009
Duke Clinical Research Institute February 2005 - January 2008
Education
North Carolina State University 1993 — 1998
North Carolina Central University
MBA, 2009
GSK December 2010 - Present
Gilead Sciences November 2009 - January 2011
PharmaNet Development Group, Inc. January 2008 - October 2009
Duke Clinical Research Institute February 2005 - January 2008
Education
North Carolina State University 1993 — 1998
North Carolina Central University
MBA, 2009
Peidi Gu's PharmaNet Development Group, Inc. Experience August 2008 - September 2011
Job Project Leader at DCRI, Duke
Industry Pharmaceuticals
Experience
DCRI, Duke April 2014 - Present
Quintiles October 2011 - April 2014
PharmaNet Development Group, Inc. August 2008 - September 2011
PPD October 2002 - July 2008
Skills
Clinical Trials, Oncology, CRO, Clinical Research, Clinical Development, EDC
Education
Peking Union Medical College 1990 — 1998
MD, Medicine
DCRI, Duke April 2014 - Present
Quintiles October 2011 - April 2014
PharmaNet Development Group, Inc. August 2008 - September 2011
PPD October 2002 - July 2008
Skills
Clinical Trials, Oncology, CRO, Clinical Research, Clinical Development, EDC
Education
Peking Union Medical College 1990 — 1998
MD, Medicine
Ann McKeon's PharmaNet Development Group, Inc. Experience February 1999 - September 2011
Job Director, Clinical Trial Management at ICON Clinical Research
Industry Pharmaceuticals
Experience
ICON Clinical Research September 2013 - Present
Worldwide Clinical Trials, Inc December 2011 - June 2013
PharmaNet Development Group, Inc. February 1999 - September 2011
Phoenix International (merged with MDS Pharma) June 1998 - February 1999
Sanofi Pharmaceuticals, Inc October 1992 - June 1998
Skills
CRO, CTMS, Clinical Development, Oncology, Clinical Trials, Therapeutic Areas, Pharmaceutical Industry, ICH-GCP, Clinical Monitoring, Clinical Data Management, EDC, GCP, Clinical Operations, Drug Development, Clinical Research, FDA, 21 CFR Part 11, Sop, Biotechnology, Pharmacovigilance, Clinical Study Design, Medical Devices, Regulatory Affairs, Vaccines, Biopharmaceuticals, Medical Writing, Lifesciences, Immunology, Regulatory Submissions, GLP, Pharmacology, Protocol, Drug Discovery, Diabetes
Education
University College Dublin, Graduate Business School 2014 — 2014
Certificate International Business Management
Boston College
BS, Biology/Chemistry
University of Chicago
Virology
ICON Clinical Research September 2013 - Present
Worldwide Clinical Trials, Inc December 2011 - June 2013
PharmaNet Development Group, Inc. February 1999 - September 2011
Phoenix International (merged with MDS Pharma) June 1998 - February 1999
Sanofi Pharmaceuticals, Inc October 1992 - June 1998
Skills
CRO, CTMS, Clinical Development, Oncology, Clinical Trials, Therapeutic Areas, Pharmaceutical Industry, ICH-GCP, Clinical Monitoring, Clinical Data Management, EDC, GCP, Clinical Operations, Drug Development, Clinical Research, FDA, 21 CFR Part 11, Sop, Biotechnology, Pharmacovigilance, Clinical Study Design, Medical Devices, Regulatory Affairs, Vaccines, Biopharmaceuticals, Medical Writing, Lifesciences, Immunology, Regulatory Submissions, GLP, Pharmacology, Protocol, Drug Discovery, Diabetes
Education
University College Dublin, Graduate Business School 2014 — 2014
Certificate International Business Management
Boston College
BS, Biology/Chemistry
University of Chicago
Virology
Jackie Brenner, SPHR's PharmaNet Development Group, Inc. Experience 2002 - 2007
Job Human Resources Manager at INVISTA
Industry Pharmaceuticals
Experience
INVISTA March 2015 - Present
WuXi AppTec November 2012 - March 2015
Gilead Sciences, Inc. (formerly Pharmasset, Inc.) 2011 - 2012
PharmaNet 2002 - 2011
PharmaNet Development Group, Inc. 2002 - 2007
Skills
Change Management, Performance Management, Employee Relations, Acquisition Integration, HRIS, Executive Coaching, Strategic Planning, Resource Management, Human Resources, Employee Engagement, Recruiting, Deferred Compensation, Training, Vendor Management, Leadership, Pharmaceutical Industry, Applicant Tracking..., Mergers & Acquisitions, Strategy, Employee Benefits, Management, Personnel Management, Team Building, Talent Acquisition, Talent Management, Policy, Project Management, Sourcing, Compensation & Benefit, Onboarding, College Recruiting, Workforce Planning, Organizational..., Technical Recruiting, Taleo, Interviews, Internet Recruiting, Temporary Placement, Succession Planning, Employer Branding, HR Policies, HR Consulting, Executive Search, Employee Training, Screening, Employment Law
Education
Villanova University 2007 — 2007
PHR/SPHR Prep Class
Drexel University 1995 — 2000
INVISTA March 2015 - Present
WuXi AppTec November 2012 - March 2015
Gilead Sciences, Inc. (formerly Pharmasset, Inc.) 2011 - 2012
PharmaNet 2002 - 2011
PharmaNet Development Group, Inc. 2002 - 2007
Skills
Change Management, Performance Management, Employee Relations, Acquisition Integration, HRIS, Executive Coaching, Strategic Planning, Resource Management, Human Resources, Employee Engagement, Recruiting, Deferred Compensation, Training, Vendor Management, Leadership, Pharmaceutical Industry, Applicant Tracking..., Mergers & Acquisitions, Strategy, Employee Benefits, Management, Personnel Management, Team Building, Talent Acquisition, Talent Management, Policy, Project Management, Sourcing, Compensation & Benefit, Onboarding, College Recruiting, Workforce Planning, Organizational..., Technical Recruiting, Taleo, Interviews, Internet Recruiting, Temporary Placement, Succession Planning, Employer Branding, HR Policies, HR Consulting, Executive Search, Employee Training, Screening, Employment Law
Education
Villanova University 2007 — 2007
PHR/SPHR Prep Class
Drexel University 1995 — 2000
Lenny Sorin's PharmaNet Development Group, Inc. Experience 2004 - 2009
Job Controller at ForceField Energy
Industry Financial Services
Experience
ForceField Energy February 2014 - Present
Vycor Medical Inc (VYCO) February 2012 - 2014
Summit Brokerage Services, Inc. 2009 - February 2012
PharmaNet Development Group, Inc. 2004 - 2009
Skills
Financial Analysis, US GAAP, Payroll, Auditing, Financial Reporting, SEC filings, Corporate Finance, Budgets, GAAP, Financial Modeling, QuickBooks, Internal Controls, Finance, Accounting, Strategic Financial..., SEC Filings
Education
Florida Atlantic University 1996 — 2001
ForceField Energy February 2014 - Present
Vycor Medical Inc (VYCO) February 2012 - 2014
Summit Brokerage Services, Inc. 2009 - February 2012
PharmaNet Development Group, Inc. 2004 - 2009
Skills
Financial Analysis, US GAAP, Payroll, Auditing, Financial Reporting, SEC filings, Corporate Finance, Budgets, GAAP, Financial Modeling, QuickBooks, Internal Controls, Finance, Accounting, Strategic Financial..., SEC Filings
Education
Florida Atlantic University 1996 — 2001
Yves Grenon's PharmaNet Development Group, Inc. Experience 2004 - 2007
Job VicePresident/Worldwide Head, Business Development, Clinical Pharmacology, PAREXEL
Industry Biotechnology
Experience
PAREXEL October 2008 - Present
West Coast Clinical Trials July 2007 - October 2008
PharmaNet January 2004 - July 2007
Anapharm 2004 - 2007
PharmaNet Development Group, Inc. 2004 - 2007
MDS Pharma Services 1999 - 2004
MDS 1999 - 2004
MDS Pharma Services 1994 - 2004
Skills
Clinical Development, Biotechnology, Pharmaceutical Industry, GCP, CRO, Clinical Research, Drug Development, Clinical Trials, GMP, Regulatory Affairs, GLP, Sop, Regulatory Submissions, EDC, Direct Sales, FDA, Lifesciences, Drug Discovery, CTMS, Biopharmaceuticals, Bioanalysis, ICH-GCP, 21 CFR Part 11, Oncology, Medical Devices, Pharmacokinetics, Sales Management, International Sales, Business Development, Technology Transfer, Strategy, Validation, Vaccines, Pharmacovigilance, Therapeutic Areas, Medical Writing, Infectious Diseases, IND, Pharmacology, Clinical Data Management, Life Sciences
Education
Concordia University 1984 — 1994
PAREXEL October 2008 - Present
West Coast Clinical Trials July 2007 - October 2008
PharmaNet January 2004 - July 2007
Anapharm 2004 - 2007
PharmaNet Development Group, Inc. 2004 - 2007
MDS Pharma Services 1999 - 2004
MDS 1999 - 2004
MDS Pharma Services 1994 - 2004
Skills
Clinical Development, Biotechnology, Pharmaceutical Industry, GCP, CRO, Clinical Research, Drug Development, Clinical Trials, GMP, Regulatory Affairs, GLP, Sop, Regulatory Submissions, EDC, Direct Sales, FDA, Lifesciences, Drug Discovery, CTMS, Biopharmaceuticals, Bioanalysis, ICH-GCP, 21 CFR Part 11, Oncology, Medical Devices, Pharmacokinetics, Sales Management, International Sales, Business Development, Technology Transfer, Strategy, Validation, Vaccines, Pharmacovigilance, Therapeutic Areas, Medical Writing, Infectious Diseases, IND, Pharmacology, Clinical Data Management, Life Sciences
Education
Concordia University 1984 — 1994
Timothy McKinlay's PharmaNet Development Group, Inc. Experience 2000 - 2000
Job Portfolio Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL January 2011 - Present
INC Research June 2008 - 2011
Locus Pharmaceuticals April 2007 - June 2008
RPS April 2004 - April 2007
Protarga April 2002 - April 2004
AstraZeneca 2001 - 2002
PharmaNet Development Group, Inc. 2000 - 2000
Skills
Drug Development, Business Development, Clinical Operations, Biotechnology, Clinical Development, CRO, Project Management, Clinical Trials, Pharmaceutics, Oncology, Chemistry, R&D, ICH-GCP, Pharmaceutical Industry, Therapeutic Areas, Regulatory Affairs, GCP, CTMS
Education
Arcadia University 1996 — 1997
BA, Biology
PAREXEL January 2011 - Present
INC Research June 2008 - 2011
Locus Pharmaceuticals April 2007 - June 2008
RPS April 2004 - April 2007
Protarga April 2002 - April 2004
AstraZeneca 2001 - 2002
PharmaNet Development Group, Inc. 2000 - 2000
Skills
Drug Development, Business Development, Clinical Operations, Biotechnology, Clinical Development, CRO, Project Management, Clinical Trials, Pharmaceutics, Oncology, Chemistry, R&D, ICH-GCP, Pharmaceutical Industry, Therapeutic Areas, Regulatory Affairs, GCP, CTMS
Education
Arcadia University 1996 — 1997
BA, Biology
Kristyn Karas's PharmaNet Development Group, Inc. Experience 2007 - Present
Job Associate Director, Global Safety & Pharmacovigilance at PharmaNet Development Group, Inc.
Industry Pharmaceuticals
Experience
PharmaNet Associate Director, Global Safety & PharmacovigilancePharmaNet Development Group, Inc.May 2011 - Present
PharmaNet Development Group, Inc. 2007 - Present
Hoffmann-La Roche 1998 - 2005
Education
Clemson University 1994 — 1998
PharmaNet Associate Director, Global Safety & PharmacovigilancePharmaNet Development Group, Inc.May 2011 - Present
PharmaNet Development Group, Inc. 2007 - Present
Hoffmann-La Roche 1998 - 2005
Education
Clemson University 1994 — 1998
Claire Bransfield's PharmaNet Development Group, Inc. Experience February 2006 - December 2006
Job Vendor Management Analyst at Bioclinica
Industry Pharmaceuticals
Experience
BioClinica 2012 - 2012
Merck 2011 - 2012
Novartis December 2006 - January 2011
Novartis Pharmaceutical Corporation 2006 - January 2011
PharmaNet Development Group, Inc. February 2006 - December 2006
ClinPhone April 2001 - January 2006
Novo Nordisk A/S July 1996 - April 2001
Novo Nordisk A/S March 1995 - June 1996
Church & Dwight, Co., Inc. February 1991 - March 1995
Schoor and Canger Municipal Engineers July 1989 - September 1990
Skills
Sop, Clinical Research, Protocol, CTMS, Training, Vendor Management, IVR, Clinical Trials, Oncology, CRO, FDA, EDC, SOP
Education
Georgian Court University 1984 — 1988
BioClinica 2012 - 2012
Merck 2011 - 2012
Novartis December 2006 - January 2011
Novartis Pharmaceutical Corporation 2006 - January 2011
PharmaNet Development Group, Inc. February 2006 - December 2006
ClinPhone April 2001 - January 2006
Novo Nordisk A/S July 1996 - April 2001
Novo Nordisk A/S March 1995 - June 1996
Church & Dwight, Co., Inc. February 1991 - March 1995
Schoor and Canger Municipal Engineers July 1989 - September 1990
Skills
Sop, Clinical Research, Protocol, CTMS, Training, Vendor Management, IVR, Clinical Trials, Oncology, CRO, FDA, EDC, SOP
Education
Georgian Court University 1984 — 1988
Debbie Mobilio's PharmaNet Development Group, Inc. Experience May 2010 - February 2011
Job Senior Associate Project Manager at Amicus Therapeutics
Industry Pharmaceuticals
Experience
Amicus Therapeutics April 2015 - Present
Amicus Therapeutics February 2013 - March 2015
Amicus Therapeutics September 2011 - January 2013
sanofi aventis February 2011 - August 2011
PharmaNet Development Group, Inc. May 2010 - February 2011
ALMAC Clinical Technologies May 2009 - April 2010
Bristol-Myers Squibb May 2008 - April 2009
Novo Nordisk November 2006 - April 2008
Bristol-Myers Squibb September 2003 - October 2006
Bristol-Myers Squibb June 2000 - August 2003
Skills
Biotechnology, CRO, CTMS, Clinical Research, Clinical Trials, Diabetes, GCP, Oncology, Pharmaceutical Industry, Process Improvement, Project Management, Quality Assurance
Education
Montclair State University
BA
Cittone Institute
Programming, President's Award
Amicus Therapeutics April 2015 - Present
Amicus Therapeutics February 2013 - March 2015
Amicus Therapeutics September 2011 - January 2013
sanofi aventis February 2011 - August 2011
PharmaNet Development Group, Inc. May 2010 - February 2011
ALMAC Clinical Technologies May 2009 - April 2010
Bristol-Myers Squibb May 2008 - April 2009
Novo Nordisk November 2006 - April 2008
Bristol-Myers Squibb September 2003 - October 2006
Bristol-Myers Squibb June 2000 - August 2003
Skills
Biotechnology, CRO, CTMS, Clinical Research, Clinical Trials, Diabetes, GCP, Oncology, Pharmaceutical Industry, Process Improvement, Project Management, Quality Assurance
Education
Montclair State University
BA
Cittone Institute
Programming, President's Award
Elaine O'Donnell's PharmaNet Development Group, Inc. Experience May 1999 - January 2010
Job Disciple & Entrepreneur
Industry Pharmaceuticals
Experience
Alive in Christ Lutheran Church August 2010 - April 2013
PharmaNet Development Group, Inc. May 1999 - January 2010
Skills
Operations Management, Grant Writing, Bible Study, Advocacy, Creative Writing, Outsourcing, Project Management, Operations Process...
Education
Lutheran Theological Seminary at Gettysburg 2009 — 2012
Certificate in Leadership of Faith Based Organizations
Eastern University 2003 — 2005
MBA
Fairleigh Dickinson University
B.A.
Westchester Community College
A.A.S.
Alive in Christ Lutheran Church August 2010 - April 2013
PharmaNet Development Group, Inc. May 1999 - January 2010
Skills
Operations Management, Grant Writing, Bible Study, Advocacy, Creative Writing, Outsourcing, Project Management, Operations Process...
Education
Lutheran Theological Seminary at Gettysburg 2009 — 2012
Certificate in Leadership of Faith Based Organizations
Eastern University 2003 — 2005
MBA
Fairleigh Dickinson University
B.A.
Westchester Community College
A.A.S.
Glenn Schuessler's PharmaNet Development Group, Inc. Experience 2000 - 2003
Job
Industry Pharmaceuticals
Experience
BioClinica, Inc. February 2010 - Present
Cephalon, Inc. 2004 - 2010
PharmaNet Development Group, Inc. 2000 - 2003
Rhone-Poulenc Rorer/Aventis 1992 - 1999
Rhone-Poulenc Rorer Pharmaceuticals, Inc. 1985 - 1992
American Health Foundation, Naylor Dana Institute for Disease Prevention 1982 - 1985
American Health Foundation, Naylor Dana Institute for Disease Prevention 1979 - 1982
Skills
EDC, Clinical Data Management, Oncology, Infectious Diseases, CRF design, Data Validation, Process Improvement, Research, Drug Discovery, Life Sciences, Pain Management, Allergy, Asthma, Metabolic Diseases, Pharmacokinetics, Phase1 - Phase 4, ICH-GCP, SOP, DMP, eCCG, Laboratory Medicine, Pharmacovigilance, Protocol
Education
New York Medical College 1983 — 1988
M.P.H., Public Health
Pace University 1974 — 1979
B.S., Biology
Villanova University
Graduate Healthcare
BioClinica, Inc. February 2010 - Present
Cephalon, Inc. 2004 - 2010
PharmaNet Development Group, Inc. 2000 - 2003
Rhone-Poulenc Rorer/Aventis 1992 - 1999
Rhone-Poulenc Rorer Pharmaceuticals, Inc. 1985 - 1992
American Health Foundation, Naylor Dana Institute for Disease Prevention 1982 - 1985
American Health Foundation, Naylor Dana Institute for Disease Prevention 1979 - 1982
Skills
EDC, Clinical Data Management, Oncology, Infectious Diseases, CRF design, Data Validation, Process Improvement, Research, Drug Discovery, Life Sciences, Pain Management, Allergy, Asthma, Metabolic Diseases, Pharmacokinetics, Phase1 - Phase 4, ICH-GCP, SOP, DMP, eCCG, Laboratory Medicine, Pharmacovigilance, Protocol
Education
New York Medical College 1983 — 1988
M.P.H., Public Health
Pace University 1974 — 1979
B.S., Biology
Villanova University
Graduate Healthcare
Lenore Burnham's PharmaNet Development Group, Inc. Experience October 2010 - April 2012
Job Senior Consultant, Global Strategic Outsourcing, Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals April 2012 - Present
PharmaNet Development Group, Inc. October 2010 - April 2012
RH Bouchard & Associates, Inc. August 2009 - 2010
ICON Development Solutions October 2006 - May 2009
sanofi-aventis June 2004 - January 2006
sanofi-aventis March 2002 - June 2004
Covance October 2000 - March 2002
ClinTrials Research June 1999 - October 2000
ClinTrials Research June 1998 - June 1999
GlaxoWellcome January 1997 - June 1998
Skills
Cost negotiation, Employee Relations, Outsourcing, Negotiation, CRO, Pharmaceutical Industry, Clinical Trials, Biotechnology, CTMS, Clinical Data Management, Clinical Development, Clinical Research, Drug Development, EDC, GCP, Management, Oncology, Phase I, Regulatory Affairs, Strategy, Therapeutic Areas
Education
Mount Holyoke College 1990 — 1994
BA, History, Biology, Chemistry
Takeda Pharmaceuticals April 2012 - Present
PharmaNet Development Group, Inc. October 2010 - April 2012
RH Bouchard & Associates, Inc. August 2009 - 2010
ICON Development Solutions October 2006 - May 2009
sanofi-aventis June 2004 - January 2006
sanofi-aventis March 2002 - June 2004
Covance October 2000 - March 2002
ClinTrials Research June 1999 - October 2000
ClinTrials Research June 1998 - June 1999
GlaxoWellcome January 1997 - June 1998
Skills
Cost negotiation, Employee Relations, Outsourcing, Negotiation, CRO, Pharmaceutical Industry, Clinical Trials, Biotechnology, CTMS, Clinical Data Management, Clinical Development, Clinical Research, Drug Development, EDC, GCP, Management, Oncology, Phase I, Regulatory Affairs, Strategy, Therapeutic Areas
Education
Mount Holyoke College 1990 — 1994
BA, History, Biology, Chemistry
Sarah Ferrie's PharmaNet Development Group, Inc. Experience September 2009 - May 2012
Job Associate Director; Financial Project Management at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical November 2013 - Present
inVentiv Health Clinical June 2012 - Present
PharmaNet Development Group, Inc. September 2009 - May 2012
PharmaNet March 2007 - August 2009
PRA International May 2004 - May 2007
CONI-SEAL INC 1998 - 2004
Skills
CTMS, Sop, CRO, Clinical Development, Clinical Trials, Regulatory Affairs, ICH-GCP, Pharmaceutical Industry, Regulatory Requirements, Oncology, Clinical Data Management, EDC, Analysis, Clinical Research, Financial Analysis, GCP, Budgets, Regulatory Submissions, Data Management, Management
Education
Georgian Court College 1996 — 1997
Bachalor of Science
The College of New Jersey 1993 — 1996
inVentiv Health Clinical November 2013 - Present
inVentiv Health Clinical June 2012 - Present
PharmaNet Development Group, Inc. September 2009 - May 2012
PharmaNet March 2007 - August 2009
PRA International May 2004 - May 2007
CONI-SEAL INC 1998 - 2004
Skills
CTMS, Sop, CRO, Clinical Development, Clinical Trials, Regulatory Affairs, ICH-GCP, Pharmaceutical Industry, Regulatory Requirements, Oncology, Clinical Data Management, EDC, Analysis, Clinical Research, Financial Analysis, GCP, Budgets, Regulatory Submissions, Data Management, Management
Education
Georgian Court College 1996 — 1997
Bachalor of Science
The College of New Jersey 1993 — 1996
Jennifer Henrick's PharmaNet Development Group, Inc. Experience 2004 - 2005
Job Associate Director, Biopharmaceutics at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Duramed Pharmaceuticals 2007 - 2009
Duramed Pharmaceuticals 2005 - 2007
PharmaNet Development Group, Inc. 2004 - 2005
Wyeth 2000 - 2004
Omnicare 1998 - 2000
Skills
Management of 50 +..., IND, Regulatory Submissions, Dermatology, Clinical Operations, Cardiology, Drug Development, Rheumatology, Diabetes, Protocol, Gastroenterology, Medical Devices, 21 CFR Part 11, Regulatory Requirements, Neuroscience, Oracle Clinical, Immunology, Clinical Study Design, Inform, Pharmaceutics
Education
Temple University 2004 — 2007
Masters of Science, Quality Assurance/Regulatory Affairs
Gwynedd-Mercy College 1992 — 1996
RN, BSN, Registered Nursing/Registered Nurse
Duramed Pharmaceuticals 2007 - 2009
Duramed Pharmaceuticals 2005 - 2007
PharmaNet Development Group, Inc. 2004 - 2005
Wyeth 2000 - 2004
Omnicare 1998 - 2000
Skills
Management of 50 +..., IND, Regulatory Submissions, Dermatology, Clinical Operations, Cardiology, Drug Development, Rheumatology, Diabetes, Protocol, Gastroenterology, Medical Devices, 21 CFR Part 11, Regulatory Requirements, Neuroscience, Oracle Clinical, Immunology, Clinical Study Design, Inform, Pharmaceutics
Education
Temple University 2004 — 2007
Masters of Science, Quality Assurance/Regulatory Affairs
Gwynedd-Mercy College 1992 — 1996
RN, BSN, Registered Nursing/Registered Nurse
Kim Sheleheda's PharmaNet Development Group, Inc. Experience August 2009 - September 2012
Job Director, Program Delivery at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical November 2014 - Present
inVentiv Health Clinical September 2012 - November 2014
PharmaNet Development Group, Inc. August 2009 - September 2012
Centocor Orthobiotech Services LLC August 2008 - August 2009
Scala Avanti Clinical Consulting April 2008 - August 2009
Radpharm January 2008 - April 2008
Novartis February 2007 - January 2008
Novo Nordisk March 2004 - February 2007
PPD 2004 - 2004
ITC 1998 - 2002
Skills
Clinical Trials, ICH-GCP, Clinical Monitoring, Clinical Research, GCP, EDC, CRO, CTMS, Clinical Development, Oncology, Drug Development
Education
Kean University 1997 — 2001
B.S., Chemistry, ACS Certified
inVentiv Health Clinical November 2014 - Present
inVentiv Health Clinical September 2012 - November 2014
PharmaNet Development Group, Inc. August 2009 - September 2012
Centocor Orthobiotech Services LLC August 2008 - August 2009
Scala Avanti Clinical Consulting April 2008 - August 2009
Radpharm January 2008 - April 2008
Novartis February 2007 - January 2008
Novo Nordisk March 2004 - February 2007
PPD 2004 - 2004
ITC 1998 - 2002
Skills
Clinical Trials, ICH-GCP, Clinical Monitoring, Clinical Research, GCP, EDC, CRO, CTMS, Clinical Development, Oncology, Drug Development
Education
Kean University 1997 — 2001
B.S., Chemistry, ACS Certified
Colleen Darcy Donahue's PharmaNet Development Group, Inc. Experience October 2008 - July 2010
Job Site Implementation Lead
Industry Research
Experience
PRA Health Sciences July 2010 - Present
PharmaNet Development Group, Inc. October 2008 - July 2010
MDS Pharma Services 2006 - 2008
Pharmaceutical Resource Corporation 2001 - 2006
Skills
Grants
Education
La Salle University
B.S., Business Administration
PRA Health Sciences July 2010 - Present
PharmaNet Development Group, Inc. October 2008 - July 2010
MDS Pharma Services 2006 - 2008
Pharmaceutical Resource Corporation 2001 - 2006
Skills
Grants
Education
La Salle University
B.S., Business Administration
Bryan Ballog's PharmaNet Development Group, Inc. Experience December 2003 - February 2005
Job Country Manager US/PR HCV Site Operations at AbbVie
Industry Pharmaceuticals
Experience
AbbVie(formerly Abbott Labs) June 2012 - Present
Abbott Laboratories February 2011 - June 2012
Abbott Laboratories July 2008 - February 2011
Takeda Global Research And Development May 2007 - July 2008
PRA International February 2005 - May 2007
PharmaNet Development Group, Inc. December 2003 - February 2005
CareStat (Battelle CRO) March 2003 - December 2003
WorldCare Clinical, LLC 2002 - 2003
Perceptive Informatics 2001 - 2002
Skills
CTMS, Clinical Trials, Clinical Monitoring, EDC, HCV, Clinical Operations, Oncology, Therapeutic Areas, Clinical Research, Protocol, Central Nervous System, Clinical Research..., CRO, Immunology, Clinical Development, ICH-GCP, Infectious Diseases, Rheumatology, Drug Development, Neurology, Gastroenterology, Vaccines, Endocrinology
Education
Colorado State University
BS, Biological Sciences
AbbVie(formerly Abbott Labs) June 2012 - Present
Abbott Laboratories February 2011 - June 2012
Abbott Laboratories July 2008 - February 2011
Takeda Global Research And Development May 2007 - July 2008
PRA International February 2005 - May 2007
PharmaNet Development Group, Inc. December 2003 - February 2005
CareStat (Battelle CRO) March 2003 - December 2003
WorldCare Clinical, LLC 2002 - 2003
Perceptive Informatics 2001 - 2002
Skills
CTMS, Clinical Trials, Clinical Monitoring, EDC, HCV, Clinical Operations, Oncology, Therapeutic Areas, Clinical Research, Protocol, Central Nervous System, Clinical Research..., CRO, Immunology, Clinical Development, ICH-GCP, Infectious Diseases, Rheumatology, Drug Development, Neurology, Gastroenterology, Vaccines, Endocrinology
Education
Colorado State University
BS, Biological Sciences
Janet Siani's PharmaNet Development Group, Inc. Experience 2002 - 2003
Job Sr. Coding & Standards Specialist, Shire
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals June 2011 - Present
Octagon Research Solutions 2005 - 2011
PharmaNet Development Group, Inc. 2002 - 2003
IBAH 1988 - 2000
Skills
Clinical Trials, Clinical Data Management, Pharmaceutical Industry
Education
La Salle University
Bachelor's degree, Computer and Information Science
Shire Pharmaceuticals June 2011 - Present
Octagon Research Solutions 2005 - 2011
PharmaNet Development Group, Inc. 2002 - 2003
IBAH 1988 - 2000
Skills
Clinical Trials, Clinical Data Management, Pharmaceutical Industry
Education
La Salle University
Bachelor's degree, Computer and Information Science
Jeffrey Freitag, MD's PharmaNet Development Group, Inc. Experience 2006 - Present
Job Executive VP, PharmaNet Consulting, & Chief Medical Officer
Industry Pharmaceuticals
Experience
PharmaNet Development Group 2006 - Present
PharmaNet Development Group, Inc. 2006 - Present
Bone Care International, Inc. 2003 - 2005
Education
Washington University in St. Louis 1976 — 1978
Renal Fellowship, Nephrology/Internal Medicine
Medical College of Wisconsin 1968 — 1972
M.D., Nephrology/Internal Medicine
PharmaNet Development Group 2006 - Present
PharmaNet Development Group, Inc. 2006 - Present
Bone Care International, Inc. 2003 - 2005
Education
Washington University in St. Louis 1976 — 1978
Renal Fellowship, Nephrology/Internal Medicine
Medical College of Wisconsin 1968 — 1972
M.D., Nephrology/Internal Medicine
Judy Narisi's PharmaNet Development Group, Inc. Experience January 2007 - April 2008
Job Manager, Clinical Outcomes at ICON plc
Industry Medical Practice
Experience
ICON Medical Imaging January 2011 - Present
Johnson & Johnson April 2008 - January 2011
PharmaNet Development Group, Inc. January 2007 - April 2008
Doylestown Hospital November 2000 - January 2007
Skills
Clinical Trials, Regulatory Submissions, Clinical Research, Women's Health, Cardiology, Medicine, Infectious Diseases, Sop, GCP, Nursing, Drug Safety, EDC, Oncology, Events for Adjudication, FDA, MedDRA, SOP
Education
Gwynedd Mercy University 1991 — 1995
BSN, Nursing
Gwyneed Mercy University
ICON Medical Imaging January 2011 - Present
Johnson & Johnson April 2008 - January 2011
PharmaNet Development Group, Inc. January 2007 - April 2008
Doylestown Hospital November 2000 - January 2007
Skills
Clinical Trials, Regulatory Submissions, Clinical Research, Women's Health, Cardiology, Medicine, Infectious Diseases, Sop, GCP, Nursing, Drug Safety, EDC, Oncology, Events for Adjudication, FDA, MedDRA, SOP
Education
Gwynedd Mercy University 1991 — 1995
BSN, Nursing
Gwyneed Mercy University
Christina Lockhart's PharmaNet Development Group, Inc. Experience July 2007 - December 2012
Job Senior Project Manager at Cato Research
Industry Pharmaceuticals
Experience
Cato Research January 2013 - Present
PharmaNet Development Group, Inc. July 2007 - December 2012
United Therapeutics February 2005 - June 2007
Tab Clinical Trials August 2004 - January 2005
Triangle Orthopaedic Associates July 2003 - August 2004
Williams-Sonoma, Inc. 1999 - 2004
Skills
EDC, GCP, Clinical Trials, Protocol, Sop, Clinical Research, CRF design, CRO, CTMS, Clinical Study Design, Clinical Development, Clinical Monitoring, ICH-GCP, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry
Education
University of the Sciences in Philadelphia 2007 — 2009
MBA, Pharmaceutical Business
Durham Technical Community College 2002 — 2004
CTRA, Clinical Research
North Carolina State University - College of Management 1997 — 1999
B.S., Management - Marketing
Wake Forest University 1995 — 1996
Management
Cato Research January 2013 - Present
PharmaNet Development Group, Inc. July 2007 - December 2012
United Therapeutics February 2005 - June 2007
Tab Clinical Trials August 2004 - January 2005
Triangle Orthopaedic Associates July 2003 - August 2004
Williams-Sonoma, Inc. 1999 - 2004
Skills
EDC, GCP, Clinical Trials, Protocol, Sop, Clinical Research, CRF design, CRO, CTMS, Clinical Study Design, Clinical Development, Clinical Monitoring, ICH-GCP, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry
Education
University of the Sciences in Philadelphia 2007 — 2009
MBA, Pharmaceutical Business
Durham Technical Community College 2002 — 2004
CTRA, Clinical Research
North Carolina State University - College of Management 1997 — 1999
B.S., Management - Marketing
Wake Forest University 1995 — 1996
Management
Douglas Wampler's PharmaNet Development Group, Inc. Experience April 2009 - October 2010
Job Sr. Site Manager on Assignment for Sanofi, Inc.
Industry Biotechnology
Experience
PRA Health Sciences January 2012 - Present
INC Research February 2011 - January 2012
PharmaNet Development Group, Inc. April 2009 - October 2010
Telik, Inc. February 2005 - November 2008
BioMarin May 2004 - December 2004
Clinimetrics May 2002 - May 2004
Quintiles Transnational March 1997 - May 2002
Skills
Clinical Trials, Rheumatoid Arthritis
Education
Acalanes
Northern Arizona University
Biology
University of Arizona
BS, General Biology
PRA Health Sciences January 2012 - Present
INC Research February 2011 - January 2012
PharmaNet Development Group, Inc. April 2009 - October 2010
Telik, Inc. February 2005 - November 2008
BioMarin May 2004 - December 2004
Clinimetrics May 2002 - May 2004
Quintiles Transnational March 1997 - May 2002
Skills
Clinical Trials, Rheumatoid Arthritis
Education
Acalanes
Northern Arizona University
Biology
University of Arizona
BS, General Biology
Bettie Neal's PharmaNet Development Group, Inc. Experience January 2001 - April 2009
Job Retired
Industry Pharmaceuticals
Experience
PharmaNet January 2001 - November 2009
PharmaNet Development Group, Inc. January 2001 - April 2009
Skills
Oncology, Inform, Data Management, CRO, Clinical Data Management, GCP, Oracle Clinical, Clinical Research, CDISC, CTMS, EDC, ICH-GCP, CRF design, Clinical Development, Clinical Trials
Education
Drexel University College of Medicine 1993 — 1995
BSN, Nursing
PharmaNet January 2001 - November 2009
PharmaNet Development Group, Inc. January 2001 - April 2009
Skills
Oncology, Inform, Data Management, CRO, Clinical Data Management, GCP, Oracle Clinical, Clinical Research, CDISC, CTMS, EDC, ICH-GCP, CRF design, Clinical Development, Clinical Trials
Education
Drexel University College of Medicine 1993 — 1995
BSN, Nursing
Brook Losh's PharmaNet Development Group, Inc. Experience January 2009 - March 2010
Job Inhouse, regional, and contract monitor
Industry Pharmaceuticals
Experience
pharma/CRO December 1997 - Present
PharmaNet Development Group, Inc. January 2009 - March 2010
Skills
Clinical Research..., Clinical Monitoring, CTMS, CRO, GCP, Clinical Development, EDC, Clinical Data Management
Education
Humboldt State University 1991 — 1994
BA, English
Humboldt State University
BA, English, Spanish
pharma/CRO December 1997 - Present
PharmaNet Development Group, Inc. January 2009 - March 2010
Skills
Clinical Research..., Clinical Monitoring, CTMS, CRO, GCP, Clinical Development, EDC, Clinical Data Management
Education
Humboldt State University 1991 — 1994
BA, English
Humboldt State University
BA, English, Spanish
Cajetan Onuoha, PhD's PharmaNet Development Group, Inc. Experience July 2004 - August 2005
Job Clinical Research Professional.
Industry Pharmaceuticals
Experience
PRA International November 2007 - Present
Quintiles, Inc August 2006 - October 2008
Quintiles August 2005 - October 2007
Quintiles, Inc August 2005 - October 2007
PharmaNet Development Group, Inc. July 2004 - August 2005
Camden City School Board November 2002 - June 2004
Education
Drexel University College of Medicine 2008 — 2010
MS, Clinical Research Organization and Management
Capella University 2002 — 2007
PhD, Education
University of Lagos 1987 — 1990
MSc, Physics
University of Nigeria 1983 — 1986
BSc, Physics/Education
PRA International November 2007 - Present
Quintiles, Inc August 2006 - October 2008
Quintiles August 2005 - October 2007
Quintiles, Inc August 2005 - October 2007
PharmaNet Development Group, Inc. July 2004 - August 2005
Camden City School Board November 2002 - June 2004
Education
Drexel University College of Medicine 2008 — 2010
MS, Clinical Research Organization and Management
Capella University 2002 — 2007
PhD, Education
University of Lagos 1987 — 1990
MSc, Physics
University of Nigeria 1983 — 1986
BSc, Physics/Education
Jill Moody Molek's PharmaNet Development Group, Inc. Experience February 2010 - January 2012
Job Sr. Clinical Project Manager at Quintiles
Industry Research
Experience
Quintiles January 2012 - August 2015
ACRP-RTP Chapter January 2012 - December 2012
PharmaNet Development Group, Inc. February 2010 - January 2012
Clinovative Research Inc. October 2007 - February 2010
PPD November 2000 - September 2007
East Carolina University August 1998 - July 2000
Skills
Clinical Trials, CTMS, Therapeutic Areas, Sop, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Patient Recruitment, Oncology, Infectious Diseases, ICH-GCP, GCP, EDC, Clinical Research..., Clinical Research, Clinical Operations, Clinical Monitoring, Clinical Development, Clinical Data Management, CRO, SOP
Education
East Carolina University 1994 — 2000
Master Degree, Exercise and Sport Science
1
Quintiles January 2012 - August 2015
ACRP-RTP Chapter January 2012 - December 2012
PharmaNet Development Group, Inc. February 2010 - January 2012
Clinovative Research Inc. October 2007 - February 2010
PPD November 2000 - September 2007
East Carolina University August 1998 - July 2000
Skills
Clinical Trials, CTMS, Therapeutic Areas, Sop, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Patient Recruitment, Oncology, Infectious Diseases, ICH-GCP, GCP, EDC, Clinical Research..., Clinical Research, Clinical Operations, Clinical Monitoring, Clinical Development, Clinical Data Management, CRO, SOP
Education
East Carolina University 1994 — 2000
Master Degree, Exercise and Sport Science
1
Haiyan Wang's PharmaNet Development Group, Inc. Experience September 2010 - January 2012
Job Associate Director, Business Development, inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical August 2014 - Present
inVentiv Health Clinical January 2012 - July 2014
PharmaNet Development Group, Inc. September 2010 - January 2012
functionalab Inc. January 2010 - December 2011
Cuccess pharmaceutical Ltd. 2000 - 2005
Shengli Hospital August 1994 - August 1997
Skills
CRO, Clinical Development, Pharmacology, Pharmaceutical Industry, Clinical Trials, Biotechnology, Clinical Research, Pharmaceutics, Oncology
Education
Concordia University 2007 — 2010
MBA
China Pharmaceutical University 1997 — 2000
MSc, Pharmacology
Shandong University 1990 — 1994
BS, Pharmaceutical Science
inVentiv Health Clinical August 2014 - Present
inVentiv Health Clinical January 2012 - July 2014
PharmaNet Development Group, Inc. September 2010 - January 2012
functionalab Inc. January 2010 - December 2011
Cuccess pharmaceutical Ltd. 2000 - 2005
Shengli Hospital August 1994 - August 1997
Skills
CRO, Clinical Development, Pharmacology, Pharmaceutical Industry, Clinical Trials, Biotechnology, Clinical Research, Pharmaceutics, Oncology
Education
Concordia University 2007 — 2010
MBA
China Pharmaceutical University 1997 — 2000
MSc, Pharmacology
Shandong University 1990 — 1994
BS, Pharmaceutical Science
Mariann Best's PharmaNet Development Group, Inc. Experience October 2007 - April 2009
Job Lead Validation Analyst at inVentiv Health Clinical
Industry Information Technology and Services
Experience
inVentiv Health Clinical July 2012 - Present
PharmaNet/i3 April 2009 - August 2012
PharmaNet Development Group, Inc. October 2007 - April 2009
PharmaNet Development Group, Inc. April 2005 - October 2007
PharmaNet Development Group, Inc. September 2004 - April 2005
ClinForce May 2003 - September 2004
Fast Track Systems September 2002 - May 2003
Fast Track Systems January 1999 - September 2002
Fast Track Systems January 1998 - January 1999
Skills
Validation, Documentation, Testing, User Acceptance Testing, 21 CFR Part 11, EDC, Requirements Analysis, Clinical Data Management, Computer System..., SDLC, Databases, SQL, Software Documentation
Education
Albright College 1992 — 1996
B.S., Psycho-biology
inVentiv Health Clinical July 2012 - Present
PharmaNet/i3 April 2009 - August 2012
PharmaNet Development Group, Inc. October 2007 - April 2009
PharmaNet Development Group, Inc. April 2005 - October 2007
PharmaNet Development Group, Inc. September 2004 - April 2005
ClinForce May 2003 - September 2004
Fast Track Systems September 2002 - May 2003
Fast Track Systems January 1999 - September 2002
Fast Track Systems January 1998 - January 1999
Skills
Validation, Documentation, Testing, User Acceptance Testing, 21 CFR Part 11, EDC, Requirements Analysis, Clinical Data Management, Computer System..., SDLC, Databases, SQL, Software Documentation
Education
Albright College 1992 — 1996
B.S., Psycho-biology
Suzanne Fink's PharmaNet Development Group, Inc. Experience August 2000 - September 2005
Job Sr. Project Lead, Clinical Data Management
Industry Pharmaceuticals
Experience
PRA Health Sciences December 2009 - Present
Premier Research Group May 2008 - December 2009
ReSearch Pharmaceutical Services 2007 - 2008
PharmaNet Development Group, Inc. August 2000 - September 2005
Encorium Oy/Ltd September 1999 - August 2000
SmithKline Beecham September 1997 - September 1998
Frankford Hospital 1991 - 1997
Skills
ICH-GCP, GCP, CRF design, Pharmaceutical Industry, Oncology, Oracle Clinical, CTMS, CRO, Clinical Development, EDC, Data Management, Clinical Trials, Clinical Data Management, 21 CFR Part 11, Therapeutic Areas, Infectious Diseases, Sop, Clinical Monitoring, SOP
Education
Arcadia University 1995 — 1998
Bachelor, Biology
Manor Jr. College 1991 — 1993
Associate, Science, Medical Laboratory Technology
PRA Health Sciences December 2009 - Present
Premier Research Group May 2008 - December 2009
ReSearch Pharmaceutical Services 2007 - 2008
PharmaNet Development Group, Inc. August 2000 - September 2005
Encorium Oy/Ltd September 1999 - August 2000
SmithKline Beecham September 1997 - September 1998
Frankford Hospital 1991 - 1997
Skills
ICH-GCP, GCP, CRF design, Pharmaceutical Industry, Oncology, Oracle Clinical, CTMS, CRO, Clinical Development, EDC, Data Management, Clinical Trials, Clinical Data Management, 21 CFR Part 11, Therapeutic Areas, Infectious Diseases, Sop, Clinical Monitoring, SOP
Education
Arcadia University 1995 — 1998
Bachelor, Biology
Manor Jr. College 1991 — 1993
Associate, Science, Medical Laboratory Technology
Ethel Moser's PharmaNet Development Group, Inc. Experience October 2006 - October 2008
Job RN, Sr. CCRA
Industry Research
Experience
PPD February 2013 - July 2014
Jubilant Clinsys October 2008 - February 2012
PharmaNet Development Group, Inc. October 2006 - October 2008
PPD July 2004 - October 2006
Colorado Allergy & Asthma Centers PC 2002 - 2004
Skills
Clinical Trials, Software Documentation, Therapeutic Areas, Clinical Development, CTMS, CRF design, ICH-GCP, CRO, GCP, Clinical Monitoring, Sop, Clinical Research, Infectious Diseases, EDC, Regulatory Submissions, Clinical Study Design, Medidata, Trial Management
Education
Front Range Community College 1992 — 1995
A.A.S, Nursing
PPD February 2013 - July 2014
Jubilant Clinsys October 2008 - February 2012
PharmaNet Development Group, Inc. October 2006 - October 2008
PPD July 2004 - October 2006
Colorado Allergy & Asthma Centers PC 2002 - 2004
Skills
Clinical Trials, Software Documentation, Therapeutic Areas, Clinical Development, CTMS, CRF design, ICH-GCP, CRO, GCP, Clinical Monitoring, Sop, Clinical Research, Infectious Diseases, EDC, Regulatory Submissions, Clinical Study Design, Medidata, Trial Management
Education
Front Range Community College 1992 — 1995
A.A.S, Nursing
Jeannette Snyder's PharmaNet Development Group, Inc. Experience 2001 - 2004
Job Data Team Lead at Quintiles
Industry Pharmaceuticals
Experience
Quintiles August 2009 - Present
PPD January 2007 - July 2009
sanofi-aventis March 2006 - November 2006
sanofi-aventis April 2005 - March 2006
Sanofi-Synthelabo 2004 - April 2005
PharmaNet Development Group, Inc. 2001 - 2004
PharmaNet Development Group, Inc. 2000 - 2001
Aventis (Formerly Rhone Poulenc Rhorer) 1994 - 2000
Merck 1991 - 1994
Skills
GCP, Clinical Trials, Oncology, Clinical Data Management, SOP, EDC, Oracle Applications, C-DISC, CRF Design, CRO, Inform, CTMS, ICH-GCP, MedDRA, 21 CFR Part 11, Data Management, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Sop, Oracle Clinical, CRF design, FDA, Validation, Medidata, Protocol
Education
Mansfield University of Pennsylvania 1972 — 1976
B.S., Music Education
Quintiles August 2009 - Present
PPD January 2007 - July 2009
sanofi-aventis March 2006 - November 2006
sanofi-aventis April 2005 - March 2006
Sanofi-Synthelabo 2004 - April 2005
PharmaNet Development Group, Inc. 2001 - 2004
PharmaNet Development Group, Inc. 2000 - 2001
Aventis (Formerly Rhone Poulenc Rhorer) 1994 - 2000
Merck 1991 - 1994
Skills
GCP, Clinical Trials, Oncology, Clinical Data Management, SOP, EDC, Oracle Applications, C-DISC, CRF Design, CRO, Inform, CTMS, ICH-GCP, MedDRA, 21 CFR Part 11, Data Management, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Sop, Oracle Clinical, CRF design, FDA, Validation, Medidata, Protocol
Education
Mansfield University of Pennsylvania 1972 — 1976
B.S., Music Education
Christina Zahn's PharmaNet Development Group, Inc. Experience November 2009 - July 2011
Job Consultant
Industry Pharmaceuticals
Experience
PharmaNet Development Group, Inc. November 2009 - July 2011
PharmaNet Development Group, Inc. February 2008 - November 2009
Taylor Technology May 2007 - January 2008
NASA Glenn Research Center May 2003 - August 2003
LSU Health Sciences Center 2002 - 2003
Centenary College of Louisiana 2000 - 2001
Skills
Quality Assurance, GLP, Bioanalysis, CRO, FDA, Tax Preparation, LIMS, Tax Accounting, Corporate Tax, Income Tax, SOP, Copywriting, Copy Editing
Education
Centenary College of Louisiana 2000 — 2004
B.S., Chemistry
PharmaNet Development Group, Inc. November 2009 - July 2011
PharmaNet Development Group, Inc. February 2008 - November 2009
Taylor Technology May 2007 - January 2008
NASA Glenn Research Center May 2003 - August 2003
LSU Health Sciences Center 2002 - 2003
Centenary College of Louisiana 2000 - 2001
Skills
Quality Assurance, GLP, Bioanalysis, CRO, FDA, Tax Preparation, LIMS, Tax Accounting, Corporate Tax, Income Tax, SOP, Copywriting, Copy Editing
Education
Centenary College of Louisiana 2000 — 2004
B.S., Chemistry
Joyce (McFarland) Rohrs's PharmaNet Development Group, Inc. Experience 2004 - 2006
Job Clinical Systems Designer at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences October 2014 - Present
Baylor College of Medicine April 2013 - February 2014
CTNeT (Statewide Clinical Trials Network of Texas) February 2012 - January 2013
Accenture January 2009 - September 2010
Merck 2007 - 2009
PharmaNet Development Group, Inc. 2004 - 2006
sanofi-aventis June 2004 - June 2005
Allstates Mortgage Company June 2003 - June 2004
Omnicare Clinical Research January 2000 - January 2003
Skills
Clinical Trials, EDC, Data Management, Oncology, Clinical Research, Oracle Clinical, GCP, CTMS, Pharmaceutical Industry, Data Analysis, Clinical Data Management, Software Documentation, Quality Assurance, Database Administration, Validation, SharePoint, Access, Process Improvement, Biotechnology
Education
Bauder College 1997 — 1999
AS, Fashion Merchandising
Montgomery County Community College
AS, Liberal Sciences
PRA Health Sciences October 2014 - Present
Baylor College of Medicine April 2013 - February 2014
CTNeT (Statewide Clinical Trials Network of Texas) February 2012 - January 2013
Accenture January 2009 - September 2010
Merck 2007 - 2009
PharmaNet Development Group, Inc. 2004 - 2006
sanofi-aventis June 2004 - June 2005
Allstates Mortgage Company June 2003 - June 2004
Omnicare Clinical Research January 2000 - January 2003
Skills
Clinical Trials, EDC, Data Management, Oncology, Clinical Research, Oracle Clinical, GCP, CTMS, Pharmaceutical Industry, Data Analysis, Clinical Data Management, Software Documentation, Quality Assurance, Database Administration, Validation, SharePoint, Access, Process Improvement, Biotechnology
Education
Bauder College 1997 — 1999
AS, Fashion Merchandising
Montgomery County Community College
AS, Liberal Sciences
Erin Malloy, CCRP's PharmaNet Development Group, Inc. Experience July 2010 - December 2010
Job Project Coordinator at Luitpold Pharmaceuticals
Industry Pharmaceuticals
Experience
Luitpold Pharmaceuticals August 2011 - Present
Luitpold Pharmaceuticals January 2011 - August 2011
PharmaNet Development Group, Inc. July 2010 - December 2010
Kelly Scientific Resources October 2009 - April 2010
Adecco/BD-TriPath June 2007 - April 2009
Medsource January 2007 - May 2007
Beardsworth CRO August 2006 - January 2007
Triangle Orthopaedic Associates January 2005 - April 2006
SRG Woolf Group/GSK August 2004 - December 2004
Tedor Pharma, Inc July 2002 - June 2004
Skills
GCP, Clinical Trials, Clinical Research, Auditing, Quality Assurance, Regulatory Affairs, Pharmaceutical Research, Microsoft Office, Regulatory Documentation, Adobe Acrobat, Mac OS, Online Research, SOP authoring, Adjudication, IRB, Animal Health, Customer Service, Microsoft Excel, Microsoft Word, Access, PowerPoint, Supply Management, Shipping Systems, Therapeutic Areas, Veterinary Medicine, CRO, Oncology, Pharmaceutical Industry, Sop, EDC, CTMS, Clinical Development, Clinical Monitoring
Education
Philadelphia University 1992 — 1997
Bachelor of Science, Fashion Design
Luitpold Pharmaceuticals August 2011 - Present
Luitpold Pharmaceuticals January 2011 - August 2011
PharmaNet Development Group, Inc. July 2010 - December 2010
Kelly Scientific Resources October 2009 - April 2010
Adecco/BD-TriPath June 2007 - April 2009
Medsource January 2007 - May 2007
Beardsworth CRO August 2006 - January 2007
Triangle Orthopaedic Associates January 2005 - April 2006
SRG Woolf Group/GSK August 2004 - December 2004
Tedor Pharma, Inc July 2002 - June 2004
Skills
GCP, Clinical Trials, Clinical Research, Auditing, Quality Assurance, Regulatory Affairs, Pharmaceutical Research, Microsoft Office, Regulatory Documentation, Adobe Acrobat, Mac OS, Online Research, SOP authoring, Adjudication, IRB, Animal Health, Customer Service, Microsoft Excel, Microsoft Word, Access, PowerPoint, Supply Management, Shipping Systems, Therapeutic Areas, Veterinary Medicine, CRO, Oncology, Pharmaceutical Industry, Sop, EDC, CTMS, Clinical Development, Clinical Monitoring
Education
Philadelphia University 1992 — 1997
Bachelor of Science, Fashion Design
Ellen Geary's PharmaNet Development Group, Inc. Experience February 2002 - October 2009
Job Sr. Clinical Trial Leader at Novartis Vaccines and Diagnostics
Industry Pharmaceuticals
Experience
Novartis Vaccines and Diagnostics August 2013 - Present
Sanofi September 2011 - July 2013
Kyowa Hakko Kirin Pharma, Inc. January 2011 - June 2011
Johnson & Johnson April 2010 - December 2010
Pharmanet Development Group, Inc. February 2002 - October 2009
Advanced Biomedical Research, Inc. (ABR) 2000 - 2002
Advanced Biologics, Inc. 1999 - 2000
GlaxoSmithKline 1997 - 1999
Merck 1996 - 1997
Skills
Clinical Trials, Clinical Research, Pharmaceutical Industry, Protocol, Endocrinology, Quality Assurance, CTMS, Clinical Study Design, GCP, CRO, Clinical Development, Oncology, EDC, Clinical Monitoring, ICH-GCP, Vaccines
Education
Gwynedd Mercy University 1992 — 1994
Registered Nurse (RN), Nursing
Temple University 1990 — 1992
Graduate School/Criminal Justice
University of New Hampshire 1983 — 1987
BA, Political Science, History, Women's Studies
Novartis Vaccines and Diagnostics August 2013 - Present
Sanofi September 2011 - July 2013
Kyowa Hakko Kirin Pharma, Inc. January 2011 - June 2011
Johnson & Johnson April 2010 - December 2010
Pharmanet Development Group, Inc. February 2002 - October 2009
Advanced Biomedical Research, Inc. (ABR) 2000 - 2002
Advanced Biologics, Inc. 1999 - 2000
GlaxoSmithKline 1997 - 1999
Merck 1996 - 1997
Skills
Clinical Trials, Clinical Research, Pharmaceutical Industry, Protocol, Endocrinology, Quality Assurance, CTMS, Clinical Study Design, GCP, CRO, Clinical Development, Oncology, EDC, Clinical Monitoring, ICH-GCP, Vaccines
Education
Gwynedd Mercy University 1992 — 1994
Registered Nurse (RN), Nursing
Temple University 1990 — 1992
Graduate School/Criminal Justice
University of New Hampshire 1983 — 1987
BA, Political Science, History, Women's Studies
Karen Re's PharmaNet Development Group, Inc. Experience October 2006 - July 2015
Job Project Manager at TFS Trial Form Support
Industry Pharmaceuticals
Experience
TFS Trial Form Support July 2015 - Present
PharmaNet Development Group, Inc. October 2006 - July 2015
Skills
GCP, EDC, CRO, CTMS, Clinical Monitoring, Medical Devices, Clinical Site Monitoring, Clinical Research, GLP
Education
John Jay College of Criminal Justice
BS, Forensic Toxicology
TFS Trial Form Support July 2015 - Present
PharmaNet Development Group, Inc. October 2006 - July 2015
Skills
GCP, EDC, CRO, CTMS, Clinical Monitoring, Medical Devices, Clinical Site Monitoring, Clinical Research, GLP
Education
John Jay College of Criminal Justice
BS, Forensic Toxicology
Jack Levine,CPA's PharmaNet Development Group, Inc. Experience 1999 - 2007
Job Principal at Jack Levine PA CPA's
Industry Accounting
Experience
Biscayne Pharmaceuticals, Inc. January 2013 - Present
Provista Diagnostics, Inc November 2011 - Present
SignPath Pharma, Inc. July 2010 - Present
State of Florida -The Florida Bar : 11th Judicial Circuit 1993 - Present
Jack Levine ,PA, CPA's 1984 - Present
Grant Life Sciences, Inc. 2004 - 2008
PharmaNet Development Group, Inc. 1999 - 2007
Miami-Dade County Public Schools 2004 - 2006
Beach Bank 2000 - 2006
Praire Fund 2000 - 2006
Skills
Accounting, Mergers, Start-ups, Corporate Governance, Auditing, Financial Analysis, Finance, Financial Reporting, Internal Controls, Managerial Finance, Budgets, Due Diligence, Private Equity, Internal Audit, Corporate Finance, SEC filings, Financial Modeling, Business Planning, Mergers & Acquisitions, Risk Management, Strategic Financial..., Strategy, Executive Management, Venture Capital, Tax, Valuation, IPO, Restructuring, Public Companies, Sarbanes-Oxley Act, US GAAP, Audit Committee, Investor Relations, Board of Directors, Acquisition Integration, GAAP, Corporate Development, CPA, M&A experience, Divestitures, Consolidation, Financial Audits, Cash Management, Business Valuation, Project Finance, Cash Flow, Capital, International Tax, Private Placements, Acquisitions
Education
New York University 1971 — 1975
Master of Arts.
City University of New York-Hunter College 1968 — 1971
BA, Economics
Biscayne Pharmaceuticals, Inc. January 2013 - Present
Provista Diagnostics, Inc November 2011 - Present
SignPath Pharma, Inc. July 2010 - Present
State of Florida -The Florida Bar : 11th Judicial Circuit 1993 - Present
Jack Levine ,PA, CPA's 1984 - Present
Grant Life Sciences, Inc. 2004 - 2008
PharmaNet Development Group, Inc. 1999 - 2007
Miami-Dade County Public Schools 2004 - 2006
Beach Bank 2000 - 2006
Praire Fund 2000 - 2006
Skills
Accounting, Mergers, Start-ups, Corporate Governance, Auditing, Financial Analysis, Finance, Financial Reporting, Internal Controls, Managerial Finance, Budgets, Due Diligence, Private Equity, Internal Audit, Corporate Finance, SEC filings, Financial Modeling, Business Planning, Mergers & Acquisitions, Risk Management, Strategic Financial..., Strategy, Executive Management, Venture Capital, Tax, Valuation, IPO, Restructuring, Public Companies, Sarbanes-Oxley Act, US GAAP, Audit Committee, Investor Relations, Board of Directors, Acquisition Integration, GAAP, Corporate Development, CPA, M&A experience, Divestitures, Consolidation, Financial Audits, Cash Management, Business Valuation, Project Finance, Cash Flow, Capital, International Tax, Private Placements, Acquisitions
Education
New York University 1971 — 1975
Master of Arts.
City University of New York-Hunter College 1968 — 1971
BA, Economics
Clarissa Echevarria, CFCM's PharmaNet Development Group, Inc. Experience February 2008 - April 2008
Job Contracts Administrator
Industry Information Technology and Services
Experience
Secure Mission Solutions a Parsons Company December 2012 - Present
GTSI June 2011 - November 2012
Global Telecom and Technology June 2008 - June 2011
PharmaNet Development Group, Inc. February 2008 - April 2008
Skills
Government Contracting, Federal Government, Budgets, PeopleSoft, Procurement, Leadership, DoD, Project Planning, FAR, Negotiation, Business Development, Strategic Planning, Operations Management, VoIP, Cross-functional Team..., Government
Education
George Mason University
BA, Global Affairs
George Mason University
Certificate, Contracting with the Federal Government
Secure Mission Solutions a Parsons Company December 2012 - Present
GTSI June 2011 - November 2012
Global Telecom and Technology June 2008 - June 2011
PharmaNet Development Group, Inc. February 2008 - April 2008
Skills
Government Contracting, Federal Government, Budgets, PeopleSoft, Procurement, Leadership, DoD, Project Planning, FAR, Negotiation, Business Development, Strategic Planning, Operations Management, VoIP, Cross-functional Team..., Government
Education
George Mason University
BA, Global Affairs
George Mason University
Certificate, Contracting with the Federal Government
Kaleo Bullard's PharmaNet Development Group, Inc. Experience August 2004 - July 2005
Job Clinical Team Leader at INC Research
Industry Pharmaceuticals
Experience
INC Research February 2010 - Present
PAREXEL August 2005 - November 2009
PAREXEL September 2007 - February 2009
PAREXEL April 2007 - September 2007
PAREXEL August 2005 - April 2007
PharmaNet Development Group, Inc. August 2004 - July 2005
Rho, Inc. 2003 - 2004
Skills
Protocol, Lotus Notes, GCP, Clinical Trials, Clinical Research, Clinical Monitoring, Clinical Operations, Drug Development, Clinical Development, ICH-GCP
Education
Campbell University 1998 — 2002
BSCR, Clinical Research
INC Research February 2010 - Present
PAREXEL August 2005 - November 2009
PAREXEL September 2007 - February 2009
PAREXEL April 2007 - September 2007
PAREXEL August 2005 - April 2007
PharmaNet Development Group, Inc. August 2004 - July 2005
Rho, Inc. 2003 - 2004
Skills
Protocol, Lotus Notes, GCP, Clinical Trials, Clinical Research, Clinical Monitoring, Clinical Operations, Drug Development, Clinical Development, ICH-GCP
Education
Campbell University 1998 — 2002
BSCR, Clinical Research
Eric Sbar's PharmaNet Development Group, Inc. Experience May 2006 - December 2007
Job Global Clinical Lead Dacomitinib at Pfizer
Industry Pharmaceuticals
Experience
Pfizer July 2014 - Present
Pfizer November 2013 - Present
Cancer Immunotherapy Consortium 2008 - Present
Kyowa Hakko Kirin Pharma, Inc. November 2012 - September 2013
Bristol-Myers Squibb October 2009 - November 2012
Bristol-Myers Squibb, Princeton, New Jersey 2007 - November 2012
BMS 2007 - March 2011
PharmaNet Development Group, Inc. May 2006 - December 2007
Skills
Creative Writing, Public Speaking, Sculpture, Pharmacovigilance, Oncology, Clinical Development, Clinical Research, Cancer, Protocol Development, Clinical, Clinical Trials, Drug Development, Medical Affairs, Clinical Study Design, Translational Medicine, Pharmaceutical Industry, Regulatory Submissions, Biomarkers, Clinical Monitoring, Medical Education, Biologics, Epidemiology, Hematology, Immunology, Medical Writing, CRO, Infectious Diseases, CTMS, Protocol, Medicine, GCP, Biotechnology, Therapeutic Areas, Cardiology, Biopharmaceuticals, Pharmaceutics, Oncology Clinical..., Pharmacology, IND, ICH-GCP, Endocrinology, Vaccines, Dermatology, Rheumatology, Regulatory Affairs, Neuroscience
Education
Philadelphia College of Osteopathic Medicine 1990 — 1994
DO, Doctor of Osteopathy
Temple University 1985 — 1988
BA, Biology
Muhlenberg College
Pfizer July 2014 - Present
Pfizer November 2013 - Present
Cancer Immunotherapy Consortium 2008 - Present
Kyowa Hakko Kirin Pharma, Inc. November 2012 - September 2013
Bristol-Myers Squibb October 2009 - November 2012
Bristol-Myers Squibb, Princeton, New Jersey 2007 - November 2012
BMS 2007 - March 2011
PharmaNet Development Group, Inc. May 2006 - December 2007
Skills
Creative Writing, Public Speaking, Sculpture, Pharmacovigilance, Oncology, Clinical Development, Clinical Research, Cancer, Protocol Development, Clinical, Clinical Trials, Drug Development, Medical Affairs, Clinical Study Design, Translational Medicine, Pharmaceutical Industry, Regulatory Submissions, Biomarkers, Clinical Monitoring, Medical Education, Biologics, Epidemiology, Hematology, Immunology, Medical Writing, CRO, Infectious Diseases, CTMS, Protocol, Medicine, GCP, Biotechnology, Therapeutic Areas, Cardiology, Biopharmaceuticals, Pharmaceutics, Oncology Clinical..., Pharmacology, IND, ICH-GCP, Endocrinology, Vaccines, Dermatology, Rheumatology, Regulatory Affairs, Neuroscience
Education
Philadelphia College of Osteopathic Medicine 1990 — 1994
DO, Doctor of Osteopathy
Temple University 1985 — 1988
BA, Biology
Muhlenberg College
Danielle Stabulis-Moretti's PharmaNet Development Group, Inc. Experience 2002 - 2004
Job DRA Operations Manager at Actelion
Industry Pharmaceuticals
Experience
Actelion January 2009 - Present
Actelion May 2007 - January 2009
Gemin X June 2005 - May 2006
Duramed Pharmaceuticals 2004 - 2006
PharmaNet Development Group, Inc. 2002 - 2004
Skills
Training, FDA, Sop, Clinical Trials, Oncology, Clinical Research, CTMS, Pharmaceutical Industry, Software Documentation, Protocol, IND, GCP, Regulatory Requirements
Education
Neumann University 2003 — 2007
BS, Liberal Studies
Actelion January 2009 - Present
Actelion May 2007 - January 2009
Gemin X June 2005 - May 2006
Duramed Pharmaceuticals 2004 - 2006
PharmaNet Development Group, Inc. 2002 - 2004
Skills
Training, FDA, Sop, Clinical Trials, Oncology, Clinical Research, CTMS, Pharmaceutical Industry, Software Documentation, Protocol, IND, GCP, Regulatory Requirements
Education
Neumann University 2003 — 2007
BS, Liberal Studies
Jacklen Gillette's PharmaNet Development Group, Inc. Experience January 2009 - September 2011
Job Trial Master Study Owner at ICON plc
Industry Pharmaceuticals
Experience
ICON plc September 2011 - Present
PharmaNet Development Group, Inc. January 2009 - September 2011
Omnicare August 2008 - October 2008
PharmaNet/i3 March 2007 - May 2008
AmerisourceBergen February 2007 - March 2007
PEI Genesis 2005 - 2006
Skills
Clinical Trials, GCP, Sop, Clinical Research, FDA, Protocol, Therapeutic Areas, CRO, CTMS, EDC, Clinical Data Management, Pharmaceutical Industry, Clinical Development, Software Documentation, Oncology, Data Entry, Clinical Study Design, Regulatory Submissions, Oracle Clinical, ICH-GCP, Microsoft Excel, Phase I, OC RDC, Clinical Operations, Infectious Diseases, 21 CFR Part 11, Clinical Monitoring, Drug Development, Biotechnology, Inform, Vaccines, SOP
Education
University of Phoenix 2011 — 2013
Bachelor of Science (B.S.), Health Care Administration
Montgomery County Community College
Liberal Arts and Sciences, General Studies and Humanities
Abington Senior High School 1997 — 2001
High School Diploma, 2001
ICON plc September 2011 - Present
PharmaNet Development Group, Inc. January 2009 - September 2011
Omnicare August 2008 - October 2008
PharmaNet/i3 March 2007 - May 2008
AmerisourceBergen February 2007 - March 2007
PEI Genesis 2005 - 2006
Skills
Clinical Trials, GCP, Sop, Clinical Research, FDA, Protocol, Therapeutic Areas, CRO, CTMS, EDC, Clinical Data Management, Pharmaceutical Industry, Clinical Development, Software Documentation, Oncology, Data Entry, Clinical Study Design, Regulatory Submissions, Oracle Clinical, ICH-GCP, Microsoft Excel, Phase I, OC RDC, Clinical Operations, Infectious Diseases, 21 CFR Part 11, Clinical Monitoring, Drug Development, Biotechnology, Inform, Vaccines, SOP
Education
University of Phoenix 2011 — 2013
Bachelor of Science (B.S.), Health Care Administration
Montgomery County Community College
Liberal Arts and Sciences, General Studies and Humanities
Abington Senior High School 1997 — 2001
High School Diploma, 2001
Nancy Powers's PharmaNet Development Group, Inc. Experience 2004 - 2010
Job Senior Manager Contracts
Industry Legal Services
Experience
Taiho Pharma USA Inc July 2011 - Present
Covance September 2010 - July 2011
Amercian Water 2010 - 2010
PharmaNet Development Group, Inc. 2004 - 2010
Education
Drexel University 2014 — 2016
Master's Degree, Clinical Research Organization and Management - currently attending
Taiho Pharma USA Inc July 2011 - Present
Covance September 2010 - July 2011
Amercian Water 2010 - 2010
PharmaNet Development Group, Inc. 2004 - 2010
Education
Drexel University 2014 — 2016
Master's Degree, Clinical Research Organization and Management - currently attending
Matthew Rocco's PharmaNet Development Group, Inc. Experience October 2006 - July 2012
Job Purchase and Property Unit at NJ Judiciary
Industry Pharmaceuticals
Experience
New Jersey Judiciary-Administrative Office of the Courts September 2013 - Present
Jefferies & Company August 2012 - September 2013
PharmaNet Development Group, Inc. October 2006 - July 2012
Tommy Hilfiger 2000 - 2006
Mutual of America July 1997 - August 2000
Viacom International Inc January 1989 - May 1997
NEC 1983 - 1989
Skills
Fleet Management, Procurement, Negotiation, Program Management, Global Sourcing, Vendor Management, Supply Management, Supply Chain, Supply Chain Management, Inventory Management, Logistics, Management, Budgets, Analysis, Retail, Forecasting, Outsourcing, Purchasing
Education
LIU Post 1984 — 1989
MBA, Management
Fordham University 1978 — 1982
BA, Political Science
New Jersey Judiciary-Administrative Office of the Courts September 2013 - Present
Jefferies & Company August 2012 - September 2013
PharmaNet Development Group, Inc. October 2006 - July 2012
Tommy Hilfiger 2000 - 2006
Mutual of America July 1997 - August 2000
Viacom International Inc January 1989 - May 1997
NEC 1983 - 1989
Skills
Fleet Management, Procurement, Negotiation, Program Management, Global Sourcing, Vendor Management, Supply Management, Supply Chain, Supply Chain Management, Inventory Management, Logistics, Management, Budgets, Analysis, Retail, Forecasting, Outsourcing, Purchasing
Education
LIU Post 1984 — 1989
MBA, Management
Fordham University 1978 — 1982
BA, Political Science
Emily Vause's PharmaNet Development Group, Inc. Experience June 2009 - January 2011
Job Clinical Informatics Manager
Industry Pharmaceuticals
Experience
PRA Health Sciences August 2015 - Present
Quintiles January 2011 - August 2015
PharmaNet Development Group, Inc. June 2009 - January 2011
PharmaNet Development Group, Inc. November 2007 - May 2009
Premier Research Group 2003 - 2005
Skills
Validation, Sop, EDC, Clinical Data Management, CRO, Pharmaceutical Industry, Oracle Clinical, Data Management, Oncology, ICH-GCP, 21 CFR Part 11, CTMS, GCP, Clinical Trials, CRF design
Education
Penfield High School
Penfield High School
Penfield High School
Radford University
BS, Anthropology
PRA Health Sciences August 2015 - Present
Quintiles January 2011 - August 2015
PharmaNet Development Group, Inc. June 2009 - January 2011
PharmaNet Development Group, Inc. November 2007 - May 2009
Premier Research Group 2003 - 2005
Skills
Validation, Sop, EDC, Clinical Data Management, CRO, Pharmaceutical Industry, Oracle Clinical, Data Management, Oncology, ICH-GCP, 21 CFR Part 11, CTMS, GCP, Clinical Trials, CRF design
Education
Penfield High School
Penfield High School
Penfield High School
Radford University
BS, Anthropology
Mark Creelman's PharmaNet Development Group, Inc. Experience April 2006 - July 2008
Job Global Director of Contracts at inVentiv Health Clinical, LLC.
Industry Pharmaceuticals
Experience
inVentiv Health Clinical July 2009 - Present
PharmaNet Development Group, Inc. April 2006 - July 2008
Biovail Technologies January 2005 - April 2006
Skills
Contract Management, Business Development, Management, Mergers & Acquisitions, Negotiation, Team Building, Risk Management, Cross-functional Team..., Pharmaceutical Industry, Clinical Trials, Clinical Research, Contract Negotiation, Vendor Management
Education
Fairleigh Dickinson University-Florham Campus 1997 — 1999
MBA, Pharmaceutical Studies
Long Island University, Southampton Campus 1990 — 1994
BS, Enviromental Science
inVentiv Health Clinical July 2009 - Present
PharmaNet Development Group, Inc. April 2006 - July 2008
Biovail Technologies January 2005 - April 2006
Skills
Contract Management, Business Development, Management, Mergers & Acquisitions, Negotiation, Team Building, Risk Management, Cross-functional Team..., Pharmaceutical Industry, Clinical Trials, Clinical Research, Contract Negotiation, Vendor Management
Education
Fairleigh Dickinson University-Florham Campus 1997 — 1999
MBA, Pharmaceutical Studies
Long Island University, Southampton Campus 1990 — 1994
BS, Enviromental Science
Joyce George's PharmaNet Development Group, Inc. Experience May 2001 - February 2004
Job Sr. Manager, Biostatistics at Kyowa Hakko Kirin Pharma, Inc.
Industry Pharmaceuticals
Experience
Kyowa Hakko Kirin Pharma, Inc. September 2012 - December 2013
Johnson & Johnson December 2010 - September 2012
PharmaNet Development Group, Inc. May 2001 - February 2004
PharmaNet Development Group, Inc. 1999 - 2001
PharmaNet Development Group, Inc. 1998 - 1999
Covance 1992 - 1998
Covance 1990 - 1992
R. W. Johnson Pharmaceutical Research Institute 1988 - 1990
Skills
CDISC, Clinical Trials, Biostatistics, Clinical Development, CRO, SAS programming, EDC, Clinical Study Design, GCP, Clinical Data Management, Statistical Programming, Clinical Research, SAS, Oncology, Regulatory Submissions, Pharmaceutical Industry, SAS Programming
Education
Kansas State University 1986 — 1988
MS, Statistics
Kansas State University 1982 — 1986
BS, Statistics
Kyowa Hakko Kirin Pharma, Inc. September 2012 - December 2013
Johnson & Johnson December 2010 - September 2012
PharmaNet Development Group, Inc. May 2001 - February 2004
PharmaNet Development Group, Inc. 1999 - 2001
PharmaNet Development Group, Inc. 1998 - 1999
Covance 1992 - 1998
Covance 1990 - 1992
R. W. Johnson Pharmaceutical Research Institute 1988 - 1990
Skills
CDISC, Clinical Trials, Biostatistics, Clinical Development, CRO, SAS programming, EDC, Clinical Study Design, GCP, Clinical Data Management, Statistical Programming, Clinical Research, SAS, Oncology, Regulatory Submissions, Pharmaceutical Industry, SAS Programming
Education
Kansas State University 1986 — 1988
MS, Statistics
Kansas State University 1982 — 1986
BS, Statistics
Jill Christiansen, CSOXM's PharmaNet Development Group, Inc. Experience November 2006 - January 2012
Job Manager, Compliance Auditing at Otsuka Pharmaceutical Companies (U.S.)
Industry Pharmaceuticals
Experience
Otsuka Pharmaceutical Companies (U.S.) January 2013 - Present
PSEG September 2012 - January 2013
PharmaNet Development Group, Inc. November 2006 - January 2012
Novartis 2012 - 2012
Coach December 2004 - April 2006
Skills
Sarbanes-Oxley Act, Auditing, Internal Controls, Financial Reporting, Accounts Receivable, Internal Audit, Management, Accounts Payable, Human Resources, Software Documentation, PeopleSoft, Risk Management, Finance, Quality Auditing, CRO, FCPA, Healthcare, Pharmaceutical Industry, Payroll
Education
Kean University 1999 — 2002
BA, Economics
University of Amsterdam 2001 — 2001
International Economics
Raritan Valley Community College 1996 — 1999
AA, Liberal Arts
Seton Hall University School of Law
Healthcare Compliance Law
Somerville High School
Somerville High School
Otsuka Pharmaceutical Companies (U.S.) January 2013 - Present
PSEG September 2012 - January 2013
PharmaNet Development Group, Inc. November 2006 - January 2012
Novartis 2012 - 2012
Coach December 2004 - April 2006
Skills
Sarbanes-Oxley Act, Auditing, Internal Controls, Financial Reporting, Accounts Receivable, Internal Audit, Management, Accounts Payable, Human Resources, Software Documentation, PeopleSoft, Risk Management, Finance, Quality Auditing, CRO, FCPA, Healthcare, Pharmaceutical Industry, Payroll
Education
Kean University 1999 — 2002
BA, Economics
University of Amsterdam 2001 — 2001
International Economics
Raritan Valley Community College 1996 — 1999
AA, Liberal Arts
Seton Hall University School of Law
Healthcare Compliance Law
Somerville High School
Somerville High School
Jill Patrick's PharmaNet Development Group, Inc. Experience July 2003 - April 2010
Job Clinical Research Professional
Industry Pharmaceuticals
Experience
Allphase Clinical Research October 2013 - Present
Robarts Clinical Trials October 2010 - July 2012
PharmaNet Development Group, Inc. July 2003 - April 2010
PRA International September 2000 - July 2003
Skills
ICH-GCP, Clinical Monitoring, EDC, CTMS, Clinical Research, Medical Devices
Education
University of Guelph 1995 — 1999
Honours Bachelor of Science, Biological Sciences
Humber College 1999 — 2000
Post-diploma certificate, Clinical Research
Allphase Clinical Research October 2013 - Present
Robarts Clinical Trials October 2010 - July 2012
PharmaNet Development Group, Inc. July 2003 - April 2010
PRA International September 2000 - July 2003
Skills
ICH-GCP, Clinical Monitoring, EDC, CTMS, Clinical Research, Medical Devices
Education
University of Guelph 1995 — 1999
Honours Bachelor of Science, Biological Sciences
Humber College 1999 — 2000
Post-diploma certificate, Clinical Research
Lauren Brenner's PharmaNet Development Group, Inc. Experience April 2007 - March 2014
Job Clinical Research Associate at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences March 2014 - Present
PharmaNet Development Group, Inc. April 2007 - March 2014
Education
New England College of Optometry 1991 — 1995
Optometry
Brandeis University 1989 — 1991
Bachelor's Degree, Psycohology
University of Wisconsin-Madison 1987 — 1989
PRA Health Sciences March 2014 - Present
PharmaNet Development Group, Inc. April 2007 - March 2014
Education
New England College of Optometry 1991 — 1995
Optometry
Brandeis University 1989 — 1991
Bachelor's Degree, Psycohology
University of Wisconsin-Madison 1987 — 1989
Magdalena Nej's PharmaNet Development Group, Inc. Experience June 2008 - June 2011
Job Staff Scientist in XenoBiotic Laboratories
Industry Pharmaceuticals
Experience
XenoBiotic Laboratories, Inc. January 2012 - Present
PharmaNet Development Group, Inc. June 2008 - June 2011
JDS Uniphase 1997 - 2002
Skills
Sop, LIMS, Mass Spectrometry, Analytical Chemistry, Chromatography, Pharmaceutical Industry, GLP, HPLC, LC-MS, CRO, Validation
Education
Rider University 2005 — 2008
BS, chemistry
Mercer County Community College 2002 — 2005
AS, chemistry, biology
XenoBiotic Laboratories, Inc. January 2012 - Present
PharmaNet Development Group, Inc. June 2008 - June 2011
JDS Uniphase 1997 - 2002
Skills
Sop, LIMS, Mass Spectrometry, Analytical Chemistry, Chromatography, Pharmaceutical Industry, GLP, HPLC, LC-MS, CRO, Validation
Education
Rider University 2005 — 2008
BS, chemistry
Mercer County Community College 2002 — 2005
AS, chemistry, biology
Latasha MAYFIELD's PharmaNet Development Group, Inc. Experience September 2010 - September 2012
Job Senior Clinical Data Manager at PharmOlam International
Industry Biotechnology
Experience
Pharm-Olam International September 2012 - June 2013
PharmaNet Development Group, Inc. September 2010 - September 2012
PharmaNet 2011 - 2011
Skills
Clinical Trials, Recruiting, Software Documentation, CRO, CTMS, Pharmaceutical Industry, EDC, Clinical Research, Biotechnology, Clinical Development, ICH-GCP
Education
CUNY Medgar Evers College
Computer Science
Pharm-Olam International September 2012 - June 2013
PharmaNet Development Group, Inc. September 2010 - September 2012
PharmaNet 2011 - 2011
Skills
Clinical Trials, Recruiting, Software Documentation, CRO, CTMS, Pharmaceutical Industry, EDC, Clinical Research, Biotechnology, Clinical Development, ICH-GCP
Education
CUNY Medgar Evers College
Computer Science
Elizabeth Tunnell's PharmaNet Development Group, Inc. Experience September 2004 - Present
Job Senior Clinical Research Associate at PharmaNet Development Group, Inc.
Industry Pharmaceuticals
Experience
PharmaNet Development Group, Inc. September 2004 - Present
inVentiv Health Clinical 2004 - 2013
PPD 2000 - 2004
The George Washington University Hospital June 1991 - July 1996
Education
East Carolina University
BSN, Nursing
University of Pennsylvania
MSN, Nursing Administration
PharmaNet Development Group, Inc. September 2004 - Present
inVentiv Health Clinical 2004 - 2013
PPD 2000 - 2004
The George Washington University Hospital June 1991 - July 1996
Education
East Carolina University
BSN, Nursing
University of Pennsylvania
MSN, Nursing Administration
Evy Moreno, BSHS, CCRP's PharmaNet Development Group, Inc. Experience June 2003 - July 2006
Job Senior CRA at Inventiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical January 2012 - Present
E.M. Research Consulting, Inc March 2011 - January 2012
i3 Research October 2010 - February 2011
Q-Med Clinical Research, Inc. March 2009 - July 2010
Noven Pharmaceutical, Inc. March 2008 - October 2008
PharmaNet Development Group, Inc. June 2003 - July 2006
University of Miami November 2001 - May 2003
Skills
GCP, Clinical Trials, EDC, ICH-GCP, CRO, IRB, Remote Monitoring, Drug Accountability, Inform, Oracle Applications, Clinical Monitoring, Clinical Research, FDA, Clinical Development, Protocol, SOP
Education
Florida International University 2005 — 2009
BSHS, Health Sciences/Minor Health Service Administration
Miami Dade Community College 1999 — 2001
Associate, Science (Concentration on Health Information Management)
Miami Dade Community College
Associate of Arts
inVentiv Health Clinical January 2012 - Present
E.M. Research Consulting, Inc March 2011 - January 2012
i3 Research October 2010 - February 2011
Q-Med Clinical Research, Inc. March 2009 - July 2010
Noven Pharmaceutical, Inc. March 2008 - October 2008
PharmaNet Development Group, Inc. June 2003 - July 2006
University of Miami November 2001 - May 2003
Skills
GCP, Clinical Trials, EDC, ICH-GCP, CRO, IRB, Remote Monitoring, Drug Accountability, Inform, Oracle Applications, Clinical Monitoring, Clinical Research, FDA, Clinical Development, Protocol, SOP
Education
Florida International University 2005 — 2009
BSHS, Health Sciences/Minor Health Service Administration
Miami Dade Community College 1999 — 2001
Associate, Science (Concentration on Health Information Management)
Miami Dade Community College
Associate of Arts
Natoya Stone Walker's PharmaNet Development Group, Inc. Experience March 2008 - June 2014
Job Manager, Business Development
Industry Pharmaceuticals
Experience
inVentiv Health Clinical May 2015 - Present
Novella Clinical, Inc. July 2014 - May 2015
PharmaNet Development Group, Inc. March 2008 - June 2014
inVentiv Health Clinical January 2007 - March 2008
inVentiv Health Clinical March 2005 - December 2006
Skills
Pharmaceutical Industry, CRO, Clinical Trials, Clinical Development, GCP, Therapeutic Areas, ICH-GCP, Strategy, Clinical Research, Oncology, Clinical Data Management, EDC, CTMS, Biotechnology, Clinical Monitoring, Life Sciences
Education
Chowan University 1993 — 1998
Bachelor of Science (B.S.), Business Administration and Management, General
inVentiv Health Clinical May 2015 - Present
Novella Clinical, Inc. July 2014 - May 2015
PharmaNet Development Group, Inc. March 2008 - June 2014
inVentiv Health Clinical January 2007 - March 2008
inVentiv Health Clinical March 2005 - December 2006
Skills
Pharmaceutical Industry, CRO, Clinical Trials, Clinical Development, GCP, Therapeutic Areas, ICH-GCP, Strategy, Clinical Research, Oncology, Clinical Data Management, EDC, CTMS, Biotechnology, Clinical Monitoring, Life Sciences
Education
Chowan University 1993 — 1998
Bachelor of Science (B.S.), Business Administration and Management, General
Jessica Sabo's PharmaNet Development Group, Inc. Experience October 2009 - May 2011
Job Finance Department
Industry Pharmaceuticals
Experience
RPS October 2009 - Present
PharmaNet Development Group, Inc. October 2009 - May 2011
Education
Keller Graduate School of Management of DeVry University 2011 — 2013
Master of Accounting and Financial Management Plus CPA, Accounting
Lansdale School of Business 2009 — 2011
Diploma, Accounting Specialist
University of the Philippines 1991 — 2000
DCPMA, Choral Conducting, Voice, Piano
RPS October 2009 - Present
PharmaNet Development Group, Inc. October 2009 - May 2011
Education
Keller Graduate School of Management of DeVry University 2011 — 2013
Master of Accounting and Financial Management Plus CPA, Accounting
Lansdale School of Business 2009 — 2011
Diploma, Accounting Specialist
University of the Philippines 1991 — 2000
DCPMA, Choral Conducting, Voice, Piano
Jennifer Stauffer, CCDM's PharmaNet Development Group, Inc. Experience December 2004 - December 2005
Job Manager, Data Management at PharmaNeti3
Industry Pharmaceuticals
Experience
inVentiv Health Clinical December 2004 - Present
PharmaNet Development Group, Inc. December 2004 - December 2005
Cephalon August 2004 - December 2005
AstraZeneca September 2003 - July 2004
Octagon Research Solutions May 2001 - June 2003
AstraZeneca February 2001 - May 2001
SCIREX Corporation May 1998 - February 2001
Skills
Clinical Data Management, EDC, CRF design, GCP, CRO, Data Management, Clinical Trials, Sop, Validation, Oncology, Clinical Research, SAS, Inform, 21 CFR Part 11, OC RDC
Education
Cabrini College 1994 — 1996
Bachelor of Science, Biology
Delaware County Community College 1992 — 1993
Associates in Science, Biology
inVentiv Health Clinical December 2004 - Present
PharmaNet Development Group, Inc. December 2004 - December 2005
Cephalon August 2004 - December 2005
AstraZeneca September 2003 - July 2004
Octagon Research Solutions May 2001 - June 2003
AstraZeneca February 2001 - May 2001
SCIREX Corporation May 1998 - February 2001
Skills
Clinical Data Management, EDC, CRF design, GCP, CRO, Data Management, Clinical Trials, Sop, Validation, Oncology, Clinical Research, SAS, Inform, 21 CFR Part 11, OC RDC
Education
Cabrini College 1994 — 1996
Bachelor of Science, Biology
Delaware County Community College 1992 — 1993
Associates in Science, Biology
Warren Wagner's PharmaNet Development Group, Inc. Experience May 2007 - Present
Job Senior Clinical Research Associate, inVentive Health Care
Industry Pharmaceuticals
Experience
PharmaNet Development Group, Inc. May 2007 - Present
PharmaNet Development Group, Inc. May 2007 - Present
Senior Clinical Research Associate, inVentive Health Care May 2007 - Present
PPD August 2004 - May 2007
Raleigh Community Hospital November 2001 - July 2003
Skills
People Management, Great People Skills, People-oriented
Education
Old Dominion University 1972 — 1974
Bachelor of Science, Medical Technology
Potomac State College of West Virginia University 1969 — 1972
Associate of Arts, Biology
PharmaNet Development Group, Inc. May 2007 - Present
PharmaNet Development Group, Inc. May 2007 - Present
Senior Clinical Research Associate, inVentive Health Care May 2007 - Present
PPD August 2004 - May 2007
Raleigh Community Hospital November 2001 - July 2003
Skills
People Management, Great People Skills, People-oriented
Education
Old Dominion University 1972 — 1974
Bachelor of Science, Medical Technology
Potomac State College of West Virginia University 1969 — 1972
Associate of Arts, Biology
Evelyn Köpke, PhD's PharmaNet Development Group, Inc. Experience 2007 - 2012
Job Director, Medical Writing at Forest Laboratories
Industry Pharmaceuticals
Experience
Forest Laboratories May 2012 - Present
PharmaNet Development Group, Inc. 2007 - 2012
Kos Pharmaceuticals July 2006 - June 2007
Skills
Medical Writing, CRO, Regulatory Affairs, Regulatory Submissions, Clinical Development, Clinical Trials, GCP, Sop, Clinical Research, Protocol, CTMS, Clinical Study Design, NDA, Immunology, ICH-GCP, Oncology, Therapeutic Areas, Pharmacovigilance
Education
Freie Universität Berlin 1984 — 1989
PhD, Molecular Biology
University of Virginia 1981 — 1983
Masters of Science, Molecular Biology
Forest Laboratories May 2012 - Present
PharmaNet Development Group, Inc. 2007 - 2012
Kos Pharmaceuticals July 2006 - June 2007
Skills
Medical Writing, CRO, Regulatory Affairs, Regulatory Submissions, Clinical Development, Clinical Trials, GCP, Sop, Clinical Research, Protocol, CTMS, Clinical Study Design, NDA, Immunology, ICH-GCP, Oncology, Therapeutic Areas, Pharmacovigilance
Education
Freie Universität Berlin 1984 — 1989
PhD, Molecular Biology
University of Virginia 1981 — 1983
Masters of Science, Molecular Biology
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY