PharmaNet/i3 Company
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PharmaNet/i3 Employees
inVentiv Health Clinical November 2012 - Present
PharmaNet/i3 April 2012 - November 2012
Kforce Clinical Research, Inc. April 2011 - November 2012
United BioSource Corporation November 2003 - April 2011
Skills
Clinical Monitoring, Clinical Trials, CTMS, ICH-GCP, Clinical Development, GCP, CRO, EDC, Pharmaceutical Industry, Protocol, Therapeutic Areas, Oncology, Clinical Research, Sop
Education
Polytechnic University
M.Sc., Managment
University of the Sciences in Philadelphia
B.Sc., Pharmacology & Toxicology
Data Management Professional June 2012 - Present
PharmaNet/i3 January 2012 - May 2012
Eli Lilly and Company May 1988 - October 2008
Skills
Microsoft Word, Microsoft Excel, PowerPoint, Inform, Gnosis, GDMS, RighTrackII, Elara, EDMS, Administrative..., Employee Benefits, Coordination, Data Center, Entrepreneurship, Internet, Youth Ministry, Document Management, Management, Vendor Management, FDA, CRO
Education
Murray State University
Computer Science/Business Management
Spencerian College
Business Administration and Management, General
Pharm-Olam International November 2013 - Present
ICON plc August 2013 - November 2013
DOCS November 2012 - August 2013
PharmaNet/i3 March 2011 - November 2012
Home July 2009 - March 2011
Quintiles June 2007 - June 2009
Allergan January 1990 - January 2000
Skills
Clinical Research, Data Management, Inform, PowerPoint, CTMS, EDC, Rheumatoid Arthritis, Clinical Monitoring, ICH-GCP, GCP, Clinical Trials, Clinical Development, Protocol, Infectious Diseases, Neurology, Diabetes
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1992 — 1994
MBA, Business
University of California, Los Angeles 1980 — 1984
Bachelor of Science, Biochemistry
Santa Monica College 1976 — 1980
Associates of Arts, Biology
PharmaNet/i3 April 2012 - Present
St. Jude Medical 2010 - 2012
Orthofix 2007 - 2009
Skills
Clinical Monitoring, EDC, ICH-GCP, GCP, CRO, Clinical Trials, Therapeutic Areas, Oracle Clinical, Oncology, CRF design, Therapeutic Area, Inform, Patient Recruitment
Education
The University of Texas at Dallas
Bachelor of Science (B.S.), Cognitive Science
The University of Texas at Dallas
Bachelor of Arts (B.A.), Psychology
Arup April 2013 - Present
PharmaNet/i3 March 2008 - January 2013
US Navy March 1999 - June 2007
Skills
Citrix, Outlook, Windows, Troubleshooting, Microsoft Exchange, Technical Support, Microsoft Office, Customer Service, HTML, Visual Basic, Microsoft Excel, Java, PowerPoint, Remote Desktop, Microsoft Word, Research, Pharmaceutical Industry, Oracle Clinical, Adobe Acrobat, Live Meeting, Photoshop, Teaching, Public Speaking, Clinical Trials, Remote User Support, English, SCCM, Nuance, WebEx, DoD Top Secret Clearance, EHR, EMR, Cisco Call Manager, Cisco Routers, Unity Connection, Office 2010, Top Secret, Active Directory, Tcpdump, TCP/IP, Windows 7, Project Management, Help Desk Support, Networking, Operating Systems, Software Installation
Education
NJIT 2009 — 2012
Bachelor's degree, Computer Technology/Computer Systems Technology, 3.4 GPA
Middlesex County College 2007 — 2009
Associates Degree, Network Administration and Support, 3.5
PPD December 2014 - Present
Allergan December 2013 - Present
inVentiv Health Clinical September 2013 - December 2013
Quintiles September 2012 - August 2013
PharmaNet/i3 April 2012 - September 2012
Kforce Clinical Research, Inc. September 2011 - April 2012
Covance March 2011 - May 2011
ReSearch Pharmaceutical Services (RPS) April 2010 - March 2011
INC Research June 2007 - March 2010
Metabasis Therapeutics, Inc January 2007 - June 2007
Skills
Please see summary, CTMS, Clinical Monitoring, GCP, CRO, Clinical Trials
Education
San Diego State University-California State University 1994 — 1997
BS, Kinesiology, 3.7
University of California, Los Angeles 1993 — 1994
UD
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
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
ICON plc October 2012 - Present
PharmaNet/i3 October 2008 - October 2012
Merck & Co May 2005 - September 2008
Liberty Healthcare 2001 - 2005
Skills
Clinical Research, Clinical Trials, Regulatory Affairs, Oncology, Pharmaceutical Industry, Applicant Tracking..., Sourcing, Biotechnology, Recruiting, Talent Acquisition, Healthcare, GCP, Executive Search, Clinical Data Management, CRO, Neurology, ICH-GCP, Technical Recruiting, Medical Writing, Human Resources, Lifesciences, CTMS, Workforce Planning, Cross-functional Team..., EDC, Organizational..., Clinical Monitoring, Change Management, Succession Planning, Temporary Placement
Education
Philadelphia College of Osteopathic Medicine 2003 — 2005
Masters, Organizational Development & Leadership
Penn State University 1991 — 1995
Bachelors, Industrial Psychology
Temple University
PRA Health Sciences August 2015 - Present
PRA Health Sciences May 2013 - July 2015
PRA Health Sciences November 2011 - April 2013
PharmaNet/i3 March 2010 - November 2011
Nortel September 2005 - September 2009
Wake County Schools 2003 - 2005
Alcatel USA 2000 - 2001
Ablest Technology Services 1992 - 2000
Skills
CTMS, Clinical Trials, Clinical Research, CRO, Regulatory Affairs, Recruiting, ICH-GCP, Lifesciences, Pharmaceutical Industry, GCP, Data Management, EDC, Technical Recruiting, Management, Start-ups, Software Documentation, Clinical Data Management, Telecommunications, Human Resources, Diabetes, Sop, Oncology, Clinical Monitoring, Protocol, Clinical Development, Biotechnology, FDA, People Skills, 21 CFR Part 11, Regulatory Submissions, Oracle Clinical, Pharmacovigilance, Therapeutic Areas, Medical Writing, Life Sciences, SOP
Education
The George Washington University School of Medicine and Health Sciences 2012 — 2013
MS in Health Sciences, Clinical Research Administration
Durham Technical Community College 2003 — 2007
AAS, Clinical Trials Research Associate
North Carolina State University
BA
Janssen Research and Development March 2015 - Present
Bristol-Myers Squibb, Princeton, New Jersey June 2008 - March 2015
PharmaNet/i3 January 2006 - June 2008
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, Clinical Development, GCP, CRO, Drug Development, ICH-GCP, Oncology, Pharmacovigilance, Therapeutic Areas, Medical Writing, Medical Affairs, Pharmaceutical Industry, Clinical Operations, Regulatory Submissions, Lean Sigma, Immunology, Fibrotic Diseases, CTMS, Protocol, Biotechnology, Regulatory Affairs, SOP
Education
Muhlenberg Harold B & Dorothy A Snyder Schools-School of Nursing
RN, Registered Nursing/Registered Nurse
Rutgers University
Master of Library & Information Science (MLIS)
Worldwide Clinical Trials March 2015 - Present
Hartford Funds September 2013 - March 2015
Hartford Funds May 2012 - September 2013
PharmaNet/i3 May 2010 - May 2012
Pershing December 2009 - May 2010
PLANCO/The Hartford June 2007 - July 2009
PLANCO/The Hartford December 2006 - May 2007
Skills
Leadership, Marketing, Training, PowerPoint, Outlook, Dreamweaver, Microsoft Word, Lotus Notes, Microsoft Office, Marketing Communications, Salesforce.com, Photoshop, Series 63, Event Planning, Time Management, Project Management, QuarkXPress, Series 6, Mutual Funds, Financial Services, Process Improvement, Meeting Planning, Adobe Creative Suite, Communication, Customer Service, Content Management, Clinical Trials
Education
Shippensburg University of Pennsylvania 2002 — 2006
Bachelor's, Social Work
Honesdale High School 1998 — 2002
High School Diploma
Novartis April 2015 - Present
Novartis June 2012 - March 2015
Novartis January 2010 - June 2012
Novartis August 2007 - January 2010
PharmaNet/i3 October 2006 - August 2007
DOV Pharmaceutical December 2005 - October 2006
Roche November 2004 - December 2005
Pfizer February 2004 - November 2004
Beardsworth Consulting Group May 2002 - February 2004
Skills
Data Management, Clinical Data Management, Oracle Clinical, EDC, Clinical Trials, CRF design, Data Validation, SAE, 3rd Party, Reconciliation, Query, Database Lock, Database Design, Vendor Management..., Peer Mentoring, Staff Training, Subject Matter Experts, UAT coordination, Document Review, Documentation, phase III, phase II, phase I, Oncology, Neuroscience, Ophthalmology, Continuous Process..., CRO, Query Writing, Software Documentation, Account Reconciliation, GCP, CDISC, Third Party Applications, Sop, Clinical Development, SOP
Education
Rutgers University-New Brunswick
Bachelors, Psychology
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
Bristol-Myers Squibb June 2013 - Present
PharmaNet/i3 March 2012 - May 2013
Ingersoll Rand August 2011 - December 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2011 - August 2011
Sandoz August 2010 - June 2011
CSA Associates December 2002 - February 2010
Merrill Lynch 1997 - 2001
Skills
Pharmaceutical Industry, Temporary Placement, Contract Recruitment, Recruiting, Talent Management, Executive Search, Human Resources, Employee Engagement, Sourcing, Talent Acquisition, Interviews, Onboarding, Personnel Management, Screening, Employee Relations, College Recruiting, Deferred Compensation, Leadership, Performance Management, Program Management, Strategic Sourcing, Internet Recruiting, Organizational..., Management, Applicant Tracking..., Succession Planning, Oncology, Employee Benefits, Pharmaceutics, Technical Recruiting, Time Management, Screening Resumes, Hiring, Benefits Negotiation, HRIS, Staffing Services, Taleo, Employer Branding, Workforce Planning, PeopleSoft, HR Consulting, HR Policies, Permanent Placement, Employee Training, New Hire Orientations
Education
New Jersey Institute of Technology 1979 — 1984
BS, Computer Science
Middlesex County College
Recruiting & Selecting - Hire Right The First Time
Muhlenberg College
Professional Human Resource Management Certification
INC Research January 2015 - Present
INC Research August 2012 - December 2014
PharmaNet/i3 October 2010 - August 2012
PPD March 2005 - October 2010
PPD March 2005 - October 2007
PRA International January 2004 - March 2005
Skills
Medical Writing, Clinical Trials, Healthcare, Clinical Development, Epidemiology, CRO, GCP, Clinical Research, Clinical Study Design, Clinical Monitoring, Medicine, Pharmaceutical Industry, Infectious Diseases, Oncology, Drug Development, Protocol, Clinical Data Management, Vaccines, CTMS, ICH-GCP, Pharmacovigilance, Regulatory Submissions, Therapeutic Areas
Education
University of Virginia 1993 — 1994
MS, Epidemiology
State University of New York at Stony Brook 1986 — 1991
Bachelor of Science (BS), Cardiorespiratory Science
Axis Group May 2014 - Present
Granite Services February 2013 - March 2014
PharmaNet/i3 October 2012 - February 2013
Skills
Financial Analysis, Active Directory, QlikView, QlikView Development, Amazon Web Services..., Data Analysis, QlikView NPrinting, Leadership
Education
Penn State University 2008 — 2012
Bachelor of Science (B.S.), Energy, Business, and Finance
Otsuka Pharmaceutical Companies (U.S.) May 2015 - Present
Covance November 2013 - April 2015
Covance April 2011 - October 2013
PharmaNet/i3 September 2010 - February 2011
Henkel Corporation March 2008 - October 2010
Skills
Clinical Research, Drug Safety, Argus Safety, Clinical Trials, Oncology, Quality Assurance, Oracle RDC, Medidata, IND, Data Management, Clinical Study Design, R&D, Hypertension, Adverse Event Reporting, Quality Control, GCP, Clinical Data Management, CRO, CTMS, Clinical Development, Regulatory Requirements, RAVE database, Cardiovascular Disease, Solid Tumor, Oracle, Pharmacovigilance
Education
Rutgers University 2004 — 2008
Bachelor of Arts (BA), Biology/Biological Sciences
PAREXEL February 2012 - Present
PharmaNet/i3 March 2008 - February 2012
i3 Research October 2007 - February 2008
Quintiles July 2005 - October 2007
PRA International November 2004 - July 2005
ICON Clinical Research October 2002 - October 2004
SCIREX Corporation December 2000 - September 2002
PRA International October 1991 - November 2000
Education
Radford University 1996 — 1998
BS, Psychology
PharmaNet/i3 January 2006 - Present
Cardiology Associates, PC April 2000 - January 2006
Skills
CRO, Clinical Trials, Clinical Monitoring, GCP, EDC, CTMS, ICH-GCP, Clinical Development, Oncology, Therapeutic Areas, Pharmaceutical Industry, Clinical Data Management, Oracle Clinical, Clinical Research, Infectious Diseases, Sop, Regulatory Submissions, Regulatory Affairs, Pharmacovigilance, Medical Writing
Education
Syracuse University 1981 — 1986
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
PRA International February 2012 - Present
PharmaNet/i3 October 2011 - January 2012
i3 Research 2003 - October 2011
i3 Research 1999 - 2003
i3 Research 1997 - 1999
Glaxo Wellcome 1995 - 1997
Burroughs Wellcome 1993 - 1995
Howard Hughes Medical Institute, Duke University Medical Center 1990 - 1993
Skills
CRO, Clinical Development, Clinical Trials, CTMS, GCP, Clinical Monitoring, EDC, Therapeutic Areas, Pharmaceutical Industry, Oncology, Infectious Diseases, Clinical Research, ICH-GCP, Clinical Data Management, Drug Development, Clinical Operations, Line Management, Trial Management, Project Management
Education
Princeton University 1984 — 1990
Ph.D., Molecular Biology
Villanova University 1978 — 1982
B.S., Chemistry
PharmaNet/i3 July 2012 - Present
sanofi-aventis April 2002 - March 2012
Skills
Molecular Biology, Drug Metabolism, Biotherapeutics, DMPK, Biotechnology, Drug Discovery, GLP, In Vitro, Assay Development, Drug Development, LC-MS, Biomarkers, Bioanalysis
Education
Rutgers University 1998 — 2001
Graduate program, Nutritional Sciences
Madras University 1993 — 1995
Master of Science, Nutritional Science
Virtua Health December 2012 - Present
PharmaNet/i3 May 2012 - November 2012
Fisher Clinical Services (Bristol), LLC September 2008 - July 2011
SPX Corporation February 2007 - August 2008
Draeger Medical Infant Care May 2005 - December 2006
IBM August 1999 - November 2004
SL WABER, INC May 1997 - August 1999
TYCO TOYS November 1993 - May 1997
COMMUNICATION BRIEFINGS January 1993 - April 1993
ADP. BISG March 1992 - January 1993
Skills
Windows 7, Lotus Notes, Lotus Domino, Unix, Access, Novell, Citrix, Norton Ghost, Acronis, Vantive, Helpstar, Active Directory, Trend Micro, Symantec Endpoint..., PC Anywhere, Dameware, IBM iSeries, Troubleshooting, Operating Systems, AS400, Servers, Hardware, XP, Disaster Recovery, System Administration, Windows Server 2003, Windows Server, TCP/IP, Windows, Computer Hardware, Data Center, FTP, Software Installation, Network Administration, Problem Solving, Microsoft Office, Outlook, Desktop Support, Laptops, Antivirus, VPN, Backup Exec, HelpStar, Technical Support, Software Documentation, Networking, Help Desk Support, Windows XP, Remote Desktop, Printers
Education
Rutgers University – Camden 1986 — 1990
Bachelor of Arts-Computer Science, Information Systems Specialization
Rowan College at Burlington County 1981 — 1983
AAS, Data Processing
Mercer County College 1976 — 1980
AAS, Flight Technology
Delran High School 1975 — 1976
Delran High School
Delran High School
Bayer HealthCare December 2012 - Present
PharmaNet/i3 April 2012 - November 2012
Kforce Clinical Research, Inc. April 2005 - April 2012
Kforce Clinical Research, Inc. August 2003 - April 2005
RESEARCH DYNAMICS CONSULTING GROUP, LTD March 2003 - August 2003
WYETH VACCINES RESEARCH April 2001 - March 2003
University of Rochester November 1997 - April 2001
WYETH-LEDERLE VACCINES November 1994 - November 1997
LEDERLE-PRAXIS BIOLOGICALS IMMUNOLOGY DEPARTMENT August 1992 - November 1994
University of Rochester Medical Center January 1990 - August 1992
Education
University of Rochester 1999 — 2001
New York State Teacher Certification, Secondary Education - Science
University of Rochester School of Medicine and Dentistry 1992 — 1994
Master of Science, Environmental Toxicology
State University of New York College at Geneseo 1987 — 1989
Bachelor of Arts, Biology
INC Research July 2012 - Present
PharmaNet/i3 January 2008 - July 2012
United health Group January 2008 - June 2011
Eisai, Inc. (Formerly MGI Pharma) July 2006 - January 2008
3M Pharmaceuticals January 2001 - July 2006
Medtronic 1999 - December 2001
Sims Deltec 1996 - 1999
Skills
Medical writing, Regulatory Affairs, Regulatory Submissions, Science, Clinical Trials, Oncology, Technical Writing, Clinical Research, Pharmaceuticals, Manuscripts, Protocol Development, Manuscript, Medical Writing, Pharmaceutical Industry, Sop, CRO, GCP, Medical Devices, Biotechnology, FDA, Clinical Study Design, Clinical Development, Pharmacovigilance, Diabetes, Infectious Diseases, Therapeutic Areas, Publication Planning, Medicine, Protocol
Education
University of Minnesota-Twin Cities 1987 — 1992
Bachelor of Science, Scientific and Technical Communication
St. Cloud State University
Bracket April 2012 - Present
PharmaNet/i3 2007 - 2012
PharmaNet/i3 2005 - 2007
Almac Group 2003 - 2005
Almac Group 2002 - 2003
Almac Group 2000 - 2002
Saint Peter’s Healthcare System 1990 - 2000
Skills
21 CFR Part 11, Quality Assurance, Clinical Trials, Pharmaceutical Industry, Computer System..., Sop, GCP, SDLC, Clinical Development, CRO, Change Control, Software Quality..., Testing, FDA, Quality Auditing, Clinical Data Management, GxP, GMP, Validation, Risk Assessment, CTMS, Software Validation, Medical Terminology, Mentoring Of Staff, Project Estimation, Mentoring, Compliance Audits, Cost Estimating, Time Management, Management, Software Documentation, Process Improvement, Data Management, Biotechnology, SOP
Education
Montclair State University
BS, Nutrition, Home Economics
Villanova University
5.0 Continuing Education units & 50 Professional Development units, Course work in Essentials of Project Management, Developing Clinical Research Coordinator Skills
inVentiv Health Clinical June 2015 - Present
PharmaNet/i3 April 2012 - Present
Kforce Clinical Research, Inc. June 2007 - June 2012
Pfizer Global Research and Development (PGRD) April 1998 - June 2007
Skills
Clinical Monitoring, ICH-GCP, Clinical Operations, Oncology, CTMS, GCP, Pharmaceutical Industry, Clinical Trials, Clinical Development, Clinical Research, CRO, Protocol, EDC, Sop, SOP
Education
University of Phoenix 2008 — 2013
Bachelor of Science (BS), Health/Health Care Administration/Management, 3.9
Missouri Southern State University
Nursing, Registered Nursing/Registered Nurse, 4.0
inVentiv Health Clinical December 2014 - Present
PharmaNet/i3 September 2009 - Present
i3 Research October 2006 - September 2009
PPD 2003 - 2006
Skills
CRO, GCP, CTMS, Clinical Trials, Clinical Development, EDC, Clinical Monitoring, ICH-GCP, Pharmaceutical Industry, Sop, Therapeutic Areas, Oncology, Regulatory Submissions, Regulatory Affairs, Clinical Data Management, Clinical Research, 21 CFR Part 11, Biotechnology, FDA, Protocol, Clinical Operations, Pharmacovigilance, Infectious Diseases
Education
Walden University 2011 — 2013
Master of Science (M.S.), Clinical Research Administration, 4.0
North Carolina Central University
B.S., Chemistry
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
PPD October 2012 - Present
PharmaNet/i3 April 2004 - September 2012
CDER, US Food and Drug Administration October 2001 - March 2004
CDER, US Food and Drug Administration May 1996 - September 2001
CDER, US Food and Drug Administration April 1991 - April 1996
Skills
Clinical Trials, Clinical, Regulatory Strategy, IND, FDA, Biosimilar development
Education
The Johns Hopkins University School of Medicine 1986 — 1991
Post-Doctoral, Molecular Biology and Genetics
University of Maryland School of Medicine 1980 — 1985
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
Rush University Medical Center- Oncology Clinical Trials December 2014 - Present
PharmaNet/i3 July 2010 - December 2011
Medical Research Center May 2010 - July 2010
Baxter Healthcare April 2007 - April 2008
Great Lakes Naval Base, IL May 2006 - October 2007
Skills
Clinical Trials, Clinical Research, Oncology, Therapeutic Areas, FDA, Sop, Infectious Diseases, Clinical Monitoring, ICH-GCP, Protocol, Pharmacovigilance, Validation, Medical Devices, CTMS, Vaccines, CRO
Education
Medical School
MD
Northwestern University
University of Illinois at Chicago
University of Karachi
Masters
PharmaNet/i3 2005 - Present
PharmaNet/i3 1998 - Present
i3 Research November 2000 - 2008
i3 Research 1999 - 2000
Kern McNeill International 1998 - 1999
DF&R 1992 - 1996
Skills
Clinical Monitoring, Clinical Trials, Clinical Research, Sop, Protocol, CTMS, EDC, CRO, GCP, ICH-GCP, Therapeutic Areas, Clinical Development, Clinical Data Management, Clinical Operations, Clinical Study Design, SOP
Education
Texas Tech University
Bachelor of Science, Registered Nursing/Registered Nurse
West Texas A&M University
BSN, Nursing
PRA Health Sciences June 2014 - Present
PharmaNet/i3 March 2011 - May 2014
Solvay Pharmaceuticals November 2003 - January 2011
Novartis Ophthalmics June 1998 - October 2003
Boehringer Mannheim March 1993 - May 1998
Skills
FDA, Clinical Trials, Pharmaceuticals, CRO, Clinical, Clinical Development, SAS, Biostatistics, Statistics, Microsoft Office, PowerPoint, Clinical Research, Pharmaceutical Industry, EDC, Clinical Study Design, Clinical Data Management, Drug Development, CDISC
Education
The George Washington University
MS, Biostatistics
University of Florida
BS, Statistics/Mathematics
The Janssen Pharmaceutical Companies of Johnson & Johnson December 2014 - Present
Pitties and Pals September 2014 - Present
The Volunteer Auxiliary For Animal Shelters Inc. May 2011 - May 2015
PharmaNet/i3 September 2012 - September 2014
Robert Half Management Resources February 2012 - June 2012
Bristol-Myers Squibb, Princeton, New Jersey January 2009 - January 2011
Bristol-Myers Squibb, Princeton, New Jersey November 2007 - December 2008
Bristol-Myers Squibb, Princeton, New Jersey August 2006 - November 2007
Bristol-Myers Squibb, Princeton, New Jersey March 2004 - August 2006
Bristol-Myers Squibb, Princeton, New Jersey November 2001 - March 2004
Education
Rider University 2002 — 2004
MBA, Business
Rider University
BS, Accounting
PharmaNet/i3 November 2009 - Present
Takeda Pharmaceuticals June 2008 - November 2009
Amgen July 2005 - June 2008
Catalyst Pharmaceutical Research April 2004 - June 2005
Aventis Pharmaceuticals November 2000 - March 2004
Hoffmann-La Roche January 1997 - November 2000
Education
University of Phoenix 2001 — 2004
MBA, Global Management
New York University 2000 — 2001
Certification in Marketing/Advertising
William Paterson University of New Jersey 1992 — 1998
BS, Biotechnology
inVentiv Health Clinical August 2013 - Present
PharmaNet/i3 June 1999 - August 2013
PharmaNet Development Group 1999 - August 2013
CMDR 1998 - 2000
Urgences Sante 1989 - 2000
Mt. Sinai Hospital 1991 - 1999
LAB Pharmcological Research Intl. 1996 - 1998
Skills
CRO, Clinical Development, Clinical Trials, Pharmaceutical Industry, GCP, Drug Development, CTMS, Biotechnology, Oncology, Bioanalysis, Clinical Research, Lifesciences, GLP, Regulatory Affairs, FDA, Clinical Monitoring, Sop, Biopharmaceuticals, Clinical Data Management, Phase I, Infectious Diseases, Hospitals, EDC, Therapeutic Areas, Clinical Operations, 21 CFR Part 11, Protocol, Drug Discovery, Regulatory Submissions, Healthcare, Vaccines, ICH-GCP, Validation, Pharmacovigilance, Medical Writing, Life Sciences, SOP
Education
Vanier College 1987 — 1990
DEC, Respiratory & Anesthesia Technology
McGill University
Biology and Physics
PharmaNet/i3 April 2011 - Present
Skills
Validation, Computer System..., CSV, GxP, Risk Management, Change Control, Quality Assurance, CAPA, 21 CFR Part 11, SDLC, GAMP, GMP, FDA, Sop, GLP, GCP, LIMS, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Regulatory Requirements, Quality System
Education
Stevens Institute of Technology
MS, Management of Technology
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1991
BA, Mathematics
Chimerix, Inc. July 2012 - August 2015
PharmaNet/i3 February 2012 - June 2012
PharmaNet/i3 September 2011 - February 2012
i3 Research February 2011 - September 2011
i3 Research February 2008 - February 2011
i3 Research February 2006 - February 2008
Neem Research May 2002 - February 2006
North Hills Internal Medicine January 2001 - February 2006
North Ridge Internal Medicine 1996 - 2001
Duke University Affiliated Physician (DUAP) 1994 - 1996
Skills
HCV, Clinical Trials, Clinical Development, CRO, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Medical Writing, Therapeutic Areas, Biotechnology, Immunology, Pharmacovigilance, Lifesciences, Vaccines, Influenza
Education
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School 1983 — 1987
Boston Univeristy 1979 — 1983
Bachelor of Arts (B.A.), Biology
PharmaNet/i3 April 2012 - Present
PharmaNet/i3 January 2007 - Present
Community Research Partners, Inc. June 2004 - January 2008
ASG, Inc./Fort Jackson August 2006 - December 2007
Skills
Pharmaceutical Industry, Regulatory Submissions, Therapeutic Areas, Oracle Clinical, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, Clinical Trials, EDC, GCP, ICH-GCP, Infectious Diseases, Leadership, Lifesciences, Neurology, Management, Oncology, Life Sciences
Education
Medical University of South Carolina 2003 — 2006
Health/Health Care Administration/Management
Marion High School 1984 — 1988
Parexel March 2012 - Present
PharmaNet/i3 August 2007 - March 2012
INC Research June 2004 - August 2007
PPD September 2002 - June 2004
INC Research November 2001 - August 2002
PAREXEL September 2001 - November 2001
PPD March 2001 - August 2001
Quintiles July 2000 - March 2001
Duke University Medical Center June 1999 - July 2000
Fox Eyecare May 1998 - August 1999
Skills
EDC, Clinical Data Management, Oracle Clinical, Clinical Trials, Clinical Research, Microsoft Office, CRF design, Data Management, Medidata, Oncology, Global Management, MS Project, Therapeutic Areas, CRF WorkManger, WebSys EDC, DataLabs EDC, Microsoft Project, InForm, Inform, CRO, GCP
Education
North Carolina State University 2012 — 2012
BioNetwork Capstone Center Certification, Concepts, Approaches, and Strategies for commissioning and qualification in support validation
North Carolina State University 1995 — 1998
B.S., Zoology
Sanderson High School 1991 — 1995
High School Diploma, Human Biology
UCB May 2013 - Present
UCB Pharma January 2012 - May 2013
PharmaNet/i3 August 2010 - December 2011
Cato Research August 2007 - August 2010
Meredith College August 2006 - May 2007
Winston-Salem State University August 2005 - May 2006
Education
Meredith College
B.S., molecular biology and chemistry
Wake Forest University School of Medicine
Ph.D., Molecular Medicine
inVentiv Health Clinical September 2012 - Present
PharmaNet/i3 June 2008 - September 2012
US Oncology June 2006 - July 2008
The University of Texas Health Science Center at Houston March 2000 - June 2006
The University of Texas Health Science Center at Houston September 1995 - February 2000
Skills
Clinical Monitoring, Oncology, Clinical Trials, CTMS, Therapeutic Areas, GCP, EDC, Clinical Research, CRO, Clinical Operations, Clinical Development, ICH-GCP, Clinical Data Management, Medical Writing, Regulatory Submissions, Infectious Diseases
Education
The University of Texas Health Science Center at Houston 1993 — 1996
MPH, Public Health
University of San Diego 1988 — 1992
BA, International Relations/Economics
PPD October 2012 - Present
PharmaNet/i3 April 2004 - October 2012
CDER, US Food and Drug Administration October 2001 - April 2004
CDER, US Food and Drug Administration April 1996 - September 2001
Skills
Clinical Trials, Regulatory Affairs, Clinical Development, FDA, Clinical Research, Drug Development, IND, Pharmaceutical Industry, Infectious Diseases, Biotechnology, Lifesciences, Oncology
Education
The Johns Hopkins University School of Medicine 1987 — 1991
Postdoctoral Fellow, Molecular Biology and Genetics
University of Maryland School of Medicine 1981 — 1986
Ph.D., Biochem and Mol. Bio.
National Taiwan University School of Medicine 1977 — 1979
Master of Science (M.S.), Biochemistry
Novella Clinical September 2015 - Present
inVentiv Health Clinical April 2015 - September 2015
PharmaNet/i3 February 2012 - March 2015
PharmaNet/i3 February 2011 - February 2012
i3 Research March 2008 - February 2011
PRA International October 2007 - February 2008
PRA International October 2006 - September 2007
PRA International July 2005 - September 2006
Skills
Oncology, EDC, Infectious Diseases, Vaccines, Project Management, Leukemia, Breast Cancer, Central Nervous System, Non-small cell lung..., Prostate cancer, Solid Tumors, Gastroenterology, mesothelioma, CRO, Clinical Data Management, Clinical Monitoring, Clinical Operations, Clinical Research, Hematology
Education
Point Loma Nazarene University 1997 — 2001
Bachelor of Arts (B.A.), History, Summa Cum Laude
InVentiv Health Clinical October 2000 - Present
PharmaNet/i3 June 2004 - July 2009
PharmaNet/i3 December 2003 - June 2004
PharmaNet/i3 October 2002 - November 2003
PharmaNet/i3 (formerly MEDEX) October 2000 - October 2002
Lippincott Williams & Wilkins July 2000 - October 2000
CoolerSmart May 2000 - July 2000
ECRI Institute January 1998 - May 2000
Education
Rutgers University
Bachelor of Arts, Biology
PRA Health Sciences March 2012 - Present
PharmaNet/i3 August 2007 - January 2012
MDS Pharma Services May 2006 - August 2007
sanofi-aventis June 2003 - May 2006
sanofi-aventis June 2001 - June 2003
Skills
Clinical Trials, EDC, Therapeutic Areas, Sop, Oncology, Clinical Research, Drug Development, Phase I, ICH-GCP, Clinical Study Design, CTMS, Patient Recruitment, Clinical Monitoring, GCP, Clinical Operations, Pharmaceutical Industry, CRO, Clinical Development, Protocol, SOP
Education
University of Phoenix 2003 — 2005
MBA, Heath Care Management
State University of New York College at Oswego 1980 — 1982
Bachelor of Arts, Zoology
State University of New York at Delhi 1978 — 1980
AAS, Veterinary Science Technology
PharmaNet/i3 April 2012 - April 2013
Kforce Clinical Research, Inc. January 2012 - April 2012
Premier Research Group March 2011 - January 2012
GE Healthcare November 2006 - September 2009
ICON Clinical Research October 2005 - November 2006
PerkinElmer Life and Analytical Sciences June 2005 - August 2005
Cambridge Health Alliance May 2004 - May 2005
CVS August 1999 - January 2004
Skills
Clinical Research, Clinical Trials, GCP, Pharmaceutical Industry, EDC, Clinical Monitoring, CTMS, Regulatory Affairs, Data Management, CRO, Clinical Data Management, FDA, Diabetes, Healthcare, Sop, Protocol
Education
The University of Manchester 2009 — 2010
MSc, Healthcare Management
Simmons College 2001 — 2005
ACS certified BSc, Chemistry
Mount St Joseph Academy 1998 — 2001
Women In Bio June 2014 - Present
Women In Bio February 2013 - June 2014
PharmaNet/i3 November 2005 - November 2012
Health Decisions June 2005 - November 2005
Ockham Development Group February 2003 - July 2005
QUIK Computing September 2002 - February 2003
INC Research April 2002 - August 2002
Duke Clinical Research Institute December 1999 - April 2002
PAREXEL July 1998 - December 1999
ClinTrials Research, Inc. 1992 - 1998
Skills
Clinical Data Management, Clinical Research, CRO, Project Management, EDC, Customer-focused, Strategic Planning, Multi-national..., Cross-cultural, RFPs, GCPs, Process Improvement, Forecasting, Feasibility Studies, Planning Budgeting &..., SAS, Data Analysis, GCP, Training, Program Management, Management, Pharmaceutical Industry, Clinical Trials
Education
North Carolina State University
Master of Business Administration (MBA), Finance, General
North Carolina State University
Bachelor of Arts (BA), Business, Management, Marketing, Feasibility Research
Grifols February 2014 - Present
KDS Clinical Research Consulting, LLC March 2012 - Present
ICON plc October 2012 - January 2014
PAREXEL April 2012 - November 2012
Quintiles February 2011 - April 2012
Quintiles October 2008 - February 2011
Quintiles October 2006 - October 2008
PharmaNet/i3 November 2005 - October 2006
PharmaNet/i3 April 2005 - November 2005
PharmaNet/i3 August 2004 - April 2005
Skills
Clinical Monitoring, Clinical Trial..., ICH-GCP, EDC, GCP, Site Inspections, Site Selection, Staff Training, Team Management, Data Management, Enrollment Management, Staff Mentoring, Budget Preparation, Internal Audit, Quality Auditing, Regulatory Submissions, Business Meetings, Invoice Processing, Payment Processing, CTMS, Clinical Development, Clinical Operations, Budgets, CRO
Education
University of North Carolina at Chapel Hill 1998 — 2001
Bachelor of Science
Surry Community College 1997 — 1999
Associates, Science
PharmaNet/i3 July 2012 - Present
PharmaNet/i3 January 2009 - July 2012
PharmaNet/i3 July 2007 - January 2009
Theradex 2000 - 2007
The Arc of Monmouth, Inc. June 1998 - October 2000
The Arc of Monmouth, Inc. May 1997 - October 2000
Skills
Oncology, CTMS, CRO, GCP, Clinical Trials, Clinical Development, EDC, Clinical Monitoring, Clinical Data Management, Drug Development, ICH-GCP, Pharmaceutical Industry, Therapeutic Areas, Infectious Diseases, Regulatory Submissions, Clinical Research, Sop, FDA, Medical Writing, Pharmacovigilance, Clinical Operations
Education
The College of New Jersey 1996 — 2000
Bachelors of Science, Biology, General
•Delaware Valley CDISC Users Network (DV_CDISC_UN) 2005 - Present
PhilaSUG 1990 - Present
PharmaNet/i3 2011 - February 2014
NESUG 1992 - November 2013
Self employed April 2009 - September 2011
Octagon Research Solutions August 2007 - April 2009
AstraZeneca August 1997 - August 2007
AstraZeneca 1997 - 2007
Merck Research Labs 1995 - 1997
Scott Paper 1970 - 1983
Skills
IT Strategy, SAS, Validation, Unix, Testing, Data Quality, HTML, Data Cleaning, COBOL, Fortran, Data Integrity, SAS programming, Data Management, Clinical Trials, Data Analysis, Pharmaceutical Industry, Clinical Data Management, 21 CFR Part 11, Data Mining, EDC, Statistics, Business Intelligence, Data Warehousing, Clinical Research, CDISC, Oncology, Statistical Programming, SDLC, Analysis, Clinical Development, Databases, Data Validation, Analytics, SDTM, Statistical Modeling, Oracle Clinical, Regulatory Submissions, CTMS, FDA, GCP, Therapeutic Areas, ICH-GCP, Computer System..., SAS Programming, SAS Base
Education
Penn State University 1961 — 1965
Bachelor's degree, Business Administration and Management, General
inVentiv Health Clinical June 2013 - Present
inVentiv Health Clinical February 2013 - May 2013
PharmaNet/i3 April 2012 - March 2013
Kforce Clinical Research, Inc. July 2006 - March 2012
Pacific Sunwear December 2005 - July 2006
Pier 1 Imports March 2005 - December 2005
Skills
Customer Service, Leadership, Team Leadership, Process Improvement, Training, Microsoft Excel, Microsoft Office, Strategic Planning, Project Management, Talent Acquisition, Temporary Placement, Inventory Management, Program Management, Retail, Change Management, Sales, Time Management, Management, Employee Relations, Finance, Human Resources, Payroll, Vendor Management, Account Management, Team Building, Access
Education
The University of North Dakota 2000 — 2005
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
The University of North Dakota 2000 — 2005
Bachelor of Arts (B.A.), History
PAREXEL October 2012 - Present
PharmaNet/i3 November 2008 - October 2012
University of Virginia 2002 - 2008
Fred Hutchinson Cancer Research Center 2002 - 2002
Skills
Biostatistics, Clinical Trials, Survival Analysis, SAS, Clinical Development, R, CDISC, Clinical Study Design, Clinical Research, Statistics, CRO, SAS programming
Education
University of Virginia
PhD, Statistics
University of Minnesota-Twin Cities
MS, Biostatistician
Peking University
BS, Biochemistry
PAREXEL October 2014 - Present
On Assignment for InClin April 2014 - September 2014
Agility Clinical, Inc. June 2013 - 2014
Synteract, Inc. September 2011 - 2013
PharmaNet/i3 January 2007 - September 2011
Pfizer 2000 - 2006
Skills
Project Management, Regulatory Submissions, 21 CFR Part 11, FDA, EDC, Regulatory Affairs, Clinical Monitoring, Cross-functional Team..., Drug Development, ICH-GCP, Feasibilities, Anti-inflammatory, Infectious Diseases, Cardiology, Team-oriented, Clinical Development, CTMS, Clinical Data Management, Therapeutic Areas, Oncology
Education
University of Michigan 1993 — 1997
Bachelor of Science, Dental Hygiene
Temple University
Master of Science, QA/RA
PharmaNet/i3 October 2011 - March 2013
Education
University of Nebraska College of Medicine 1985 — 1991
Nebraska Wesleyan University 1981 — 1985
BS, Biology
York High School 1977 — 1981
Direct Energy August 2014 - Present
EMS USA, Inc. July 2013 - August 2014
PetroSkills April 2012 - July 2013
PharmaNet/i3 May 2004 - April 2012
Texas School of Business 2002 - 2004
MCFA 1998 - 1999
Corbett Personnel 1996 - 1998
Skills
Employee Relations, Performance Management, Applicant Tracking..., Talent Acquisition, Onboarding, HRIS, Talent Management, Human Resources, Deferred Compensation, SPHR, Succession Planning, Organizational..., HR Policies, Workforce Planning, Recruiting, Employee Engagement, Employee Benefits, Benefits Administration, College Recruiting, Leadership Development, Technical Recruiting, Personnel Management, Payroll, New Hire Orientations, PeopleSoft, Temporary Placement, Hiring, Compensation & Benefit, Policy, Management, Job Descriptions, Temporary Staffing, Interviews
Education
University of Maryland University College 1992 — 1994
Psychology, Psychology/Sociology, 4.0
Texas A&M University
PharmaNet/i3 September 2010 - Present
Takeda Pharmaceuticals 2008 - June 2012
KForce Clinical Research December 2008 - September 2010
Takeda December 2008 - September 2010
GlaxoSmithKline Biologicals October 2007 - November 2008
GlaxoSmithKline 2007 - 2008
St. Edward's University 2006 - 2008
Execupharm 2007 - 2007
Pfizer 1997 - 2007
Pharmacia 2001 - 2004
Skills
CTMS, GCP, Drug Development, Clinical Study Design, CRO, EDC, Clinical Pharmacology, Clinical Research, Clinical Trials, Clinical Monitoring, Protocol, Pharmaceutical Industry, Clinical Development, ICH-GCP, Oncology, Clinical Operations, Therapeutic Areas
Education
St. Edward's University 2006 — 2008
MS, Organizational Leadership and Ethics
Purdue University 1985 — 1991
MS, Exercise Physiology
Achillion Pharmaceuticals, Inc January 2014 - Present
Achillion Pharmaceuticals May 2013 - Present
PharmaNet/i3 February 2011 - May 2013
PharmaNet/i3 April 2010 - February 2011
Pfizer January 2006 - September 2010
Pfizer Global Research & Development November 2003 - December 2005
Pfizer Global Research & Development July 2001 - October 2003
Pfizer (formerly Warner-Lambert/Parke-Davis) February 1997 - June 2001
Pfizer September 1995 - January 1997
Skills
Medical Writing, Department Management, Clinical, CRO, Pharmaceuticals, Clinical Development, Therapeutic areas, IND, Clinical Trials, Cross-functional..., Project Management, Project Portfolio..., Regulatory Affairs, Clinical Study Design, Protocol, Pharmaceutical Industry, Clinical Research, Biotechnology, Infectious Diseases, 21 CFR Part 11, Therapeutic Areas, GCP, Management, Regulatory Submissions, ICH-GCP, FDA, Oncology, EDC, Pharmaceutics, Drug Development, Vaccines, Pharmacovigilance, CTMS, Dermatology, Medical Affairs, Clinical Data Management
Education
Quinlan School of Business, Loyola University Chicago 1979 — 1981
MBA, Business Administration
Valparaiso University 1974 — 1978
BS, Biology, Chemistry
Arbonne Independent Consultant October 2013 - Present
ICON plc October 2012 - Present
PharmaNet/i3 June 2006 - October 2012
PRA International September 1998 - June 2006
Skills
Medical Terminology
Education
Mary Baldwin College 1994 — 1998
B.A, Health Care Administration
PPD November 2014 - Present
PharmaNet/i3 May 2012 - November 2014
Symbiance Inc. January 2011 - May 2012
PPD November 2009 - December 2010
Cato Research August 2009 - November 2009
Symbiance Inc. May 2006 - August 2009
Skills
CDISC, Biostatistics, Clinical Trials, SAS, SAS programming, SDTM, Clinical Study Design, Survival Analysis, Clinical Research, Oncology, Statistical Modeling, R, Statistical Consulting, GCP, EDC, CRO, Statistical Programming, Statistics, Clinical Data Management, Pharmaceutical Industry, Therapeutic Areas, Clinical Development, Data Management, Regulatory Submissions, Infectious Diseases, Multivariate Analysis, SAS Programming
Education
Rutgers University-New Brunswick 2004 — 2006
Master, Statistics
PSI-CRO February 2014 - Present
Quintiles April 2013 - November 2013
PharmaNet/i3 November 2010 - March 2013
Kendle International February 2008 - April 2009
Amgen April 1998 - October 2007
Skills
Clinical Trials, ICH-GCP, Oncology, Medicine, CTMS, Clinical Data Management, Clinical Development
Education
National University 2006 — 2009
B.A., Psychology
Taiho Oncology Inc. July 2015 - Present
Onconova November 2012 - June 2015
PharmaNet/i3 2010 - November 2012
Transave January 2008 - March 2011
Amicus Therapeutics October 2005 - March 2008
Pharmanet 1997 - 2005
Covance 1989 - 1997
Skills
Regulatory Submissions, Biotechnology, Clinical Operations, Clinical Research, Pharmaceutical Industry, Clinical Trials, CRO, GCP, Clinical Development, CTMS, Oncology, ICH-GCP, Drug Development, Clinical Monitoring, Protocol, EDC
Education
Rutgers University-New Brunswick 1983 — 1987
PRA Health Sciences January 2015 - Present
Quintiles (GFR contracted to Amgen) August 2012 - December 2014
PharmaNet/i3 April 2012 - August 2012
Kforce Clinical Research, Inc. June 2011 - March 2012
Quintiles May 2008 - June 2011
Omnicare Clinical Research August 2007 - May 2008
Fox Chase Cancer Center November 2004 - August 2007
Graduate Hospital-Tenet Healthcare March 2001 - February 2007
Skills
ICH-GCP, CTMS, Clinical Trials, Clinical Research, Oncology, EDC, GCP, CRO, Clinical Data Management, Clinical Monitoring, Clinical Development, Oracle Clinical, Protocol
Education
Temple University 2000 — 2004
BS
Tashkent City Medical College named after P. F. Borovsky 1987 — 1990
Diploma
Mapi Group September 2015 - Present
Mapi Group July 2015 - Present
Canadian Red Cross November 2014 - June 2015
Canadian Red Cross July 2012 - November 2014
Société des Parents Terre des Jeunes June 2012 - June 2014
PharmaNet/i3 April 2009 - January 2012
Anapharm May 2008 - April 2009
Anapharm November 2002 - May 2008
MDS Pharma Services July 2000 - November 2002
Medina International May 1999 - July 2000
Skills
Root Cause Analysis, Continuous Improvement, Audit and Due Diligence, SOP, Quality Assurance, CAPA, Compliance, GxP, Audit, GLP, GCP, CRO, Quality Systems, Quality System, Lifesciences, Change Control, Pharmaceutical Industry, Microbiology, Sop, EDC, R&D, 21 CFR Part 11, Computer System..., Quality Control, Infectious Diseases, Medical Devices, Biotechnology, Data Management, Oncology, Auditing, Clinical Monitoring, Clinical Trials, Therapeutic Areas, Quality Auditing, ICH-GCP, Biopharmaceuticals, Clinical Research, Drug Development, Protocol, Software Documentation, Leadership, Clinical Development, Pharmacovigilance, Laboratory, Vaccines, Life Sciences
Education
McGill University - Macdonald Campus 1996 — 1999
B.Sc., Microbiology
Université du Québec à Montréal / UQAM 1992 — 1995
B.A., Teaching
ICON plc May 2013 - Present
PharmaNet/i3 June 2011 - April 2013
i3 Research July 2004 - June 2011
Skills
Contract Negotiation, Financial Analysis, Forecasting, Financial Modeling, Hyperion Enterprise, Variance Analysis, PeopleSoft, Sarbanes-Oxley Act, Sarbanes-Oxley, Team Leadership, Pharmaceutical Industry, Finance, CRO, Data Analysis, SAP, Financial Reporting, Project Finance, Process Improvement, Microsoft Word, Management
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2004
Master of Business Administration (MBA), Finance
inVentiv Health clinical January 2013 - Present
PharmaNet/i3 June 2011 - December 2012
PharmaNet March 2007 - June 2011
Covance 1983 - 2006
G.H. Besselaar Associates 1983 - 1989
Skills
Recruiting, Strategic Planning, Deferred Compensation, Human Resources, Talent Acquisition, Talent Management, Training, Project Management, Personnel Management, Operations Management, Management, Strategy, Vendor Management, Leadership, Applicant Tracking..., Employee Relations, Employee Engagement, Performance Management, Strategic HR, Employee Benefits, Onboarding, Organizational..., Succession Planning, HRIS, College Recruiting
Education
Rider University
Bachelor of Science (B.S.), Business Administration and Management, General
Self-Employed Statistical Programmer June 2014 - June 2015
DataCeutics, Inc. September 2013 - May 2014
Cognizant Technology Solutions April 2013 - August 2013
PharmaNet/i3 July 2011 - April 2013
Bristol-Myers Squibb June 2006 - March 2011
BioCor 2005 - 2006
Johnson & Johnson 2003 - 2005
Prudential Financial June 1995 - April 1997
Online Software International, Inc. October 1986 - September 1991
Martin Marietta May 1984 - October 1986
Skills
Biostatistics, Clinical Data Management, Clinical Trials, CRO, CDISC, SAS, Statistical Programming, Bioinformatics, Software Development, SDTM, ADaM, Pharmaceutical Industry, Clinical Research, SAS programming, 21 CFR Part 11, RAMIS, Programming Languages, Clinical Development, Oracle Clinical, Data Management, Oncology, SAS Programming
Education
New Jersey Institute of Technology 2003 — 2009
M.S., Bioinformatics
Downingtown High School
University of Pennsylvania
B.A., Mathematics
inVentiv Health July 2014 - Present
PharmaNet/i3 January 2013 - June 2014
PharmaNet/i3 . June 2010 - December 2012
PharmaNet October 2007 - June 2010
iGATE Global Solutions January 2006 - September 2007
Skills
21 CFR Part 11, Data Management, CTMS, Pharmaceutical Industry, CRO, Validation, EDC
Education
National Institute of Information Technology 1990 — 1996
University of Calcutta 1991 — 1993
b.com, commerce
PharmaNet/i3 October 2011 - Present
i3 Research December 2007 - October 2011
Premier Research Group January 2007 - November 2007
Premier Research Group (formerly SCIREX) January 2002 - December 2006
SCIREX Corporation January 2001 - December 2002
SCIREX Corporation December 1999 - December 2001
Covance May 1998 - November 1999
Covance March 1997 - April 1998
Covance May 1996 - February 1997
Covance November 1994 - April 1995
Skills
CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, EDC, GCP, Leadership, Management, Negotiation, Neurology, Oncology, Program Development, Project Management, Psychiatry, Rheumatology
Education
Princeton University 1988 — 1992
Nicholas County High School 1985 — 1988
University of Florida
MS, Pharmacy - Clinical Research Regulation & Ethics
inVentiv Health Clinical June 2013 - Present
PharmaNet/i3 March 2012 - June 2013
i3 Research March 2011 - March 2012
i3 Research 2007 - March 2011
PPD March 2003 - October 2007
Skills
Clinical Research, GCP, Clinical Trials, Microsoft Office, CRO, CTMS, Clinical Development, Data Management, Clinical Monitoring, ICH-GCP, EDC, Regulatory Submissions
Education
Strayer University 2003 — 2007
East Carolina University
Bachelor of Business Administration (BBA), Business Administration and Management, General
PPD September 2015 - Present
Novella Clinical, Inc. April 2015 - June 2015
PPD January 2015 - March 2015
PPD March 2012 - September 2014
PharmaNet/i3 January 2012 - March 2012
Datatrial September 2011 - December 2011
PPD May 2011 - August 2011
Datatrial December 2010 - May 2011
Health Decisions January 2007 - November 2010
PPD August 2004 - January 2007
Skills
Microsoft Office, Oracle Clinical, Data Entry, Data Management, Validation, EDC, Query, Clinical Data Management, Outlook, Excel, Windows, Query Writing, Clinical Trials, Inform, Medidata, Clinical Research, Protocol, CRO, CDISC, GCP, CTMS, ICH-GCP, 21 CFR Part 11, Pharmaceutical Industry, SAS, Therapeutic Areas, MedDRA, Oncology, Clinical Development, Sop, Infectious Diseases, Regulatory Submissions, SAE Reconciliation, Data Validation, Clinical Data, GCPs, Therapeutic Area, SDTM, Clinical Study Design, Microsoft Excel, SOP
Education
North Carolina Central University 1980 — 1986
New Hanover High School 1976 — 1979
Diploma, College Prep
JPMorgan Chase & Co. December 2013 - Present
JPMorgan Chase & Co. November 2012 - December 2013
PharmaNet/i3 May 2011 - November 2012
inVentiv Clinical Solutions May 2008 - April 2011
inVentiv Clinical Solutions May 2007 - April 2008
inVentiv Clinical Solutions February 2004 - May 2007
Computer Sciences Corporation December 2001 - August 2002
Internosis @ Pfizer April 2000 - November 2001
Avaya January 1999 - March 2000
Vanstar / Inacom August 1997 - December 1998
Skills
SharePoint 2010, MOSS 2007, WSS 3.0, SharePoint, SharePoint Designer, InfoPath, MS Project, Business Analysis, Process Improvement, Technical Writing, Requirements Gathering, Requirement..., Computer System..., Active Directory, Windows Server, Troubleshooting, SDLC, Change Management, Microsoft Office..., ITIL, Project Management, Infrastructure, Root Cause Analysis, MCSE 2003, Requirements Analysis, Integration, Vendor Management, IIS, Software Documentation, Analysis, Leadership, Enterprise Software, Visio, Management, Disaster Recovery, IT Management, Information Technology, Technical Support, System Deployment, Training, Databases, System Administration, Microsoft Exchange, Business Process, Microsoft SQL Server, Citrix, Data Center, Governance, Virtualization, VMware ESX
Education
Stevens Institute of Technology 1994 — 1996
Civil Engineering / Mechanical Engineering
Christian Brothers Academy (Lincroft, NJ) 1990 — 1994
High School
TFS Trial Form Support September 2014 - Present
PharmaNet/i3 May 2009 - September 2014
PharmaNet July 2004 - April 2009
PharmaNet Development Group, Inc. July 2002 - July 2004
MedImmune 1996 - 2002
Otsuka America Pharmaceutical, Inc. 1995 - 1996
Otsuka America Pharmaceutical, Inc. 1995 - 1996
Skills
Oracle Clinical, Clinical Data Management, EDC, 21 CFR Part 11, CDISC, CRF design, CRO, CTMS, Clinical Development, Clinical Trials, Data Management, GCP, ICH-GCP, Oncology, Pharmaceutical Industry, Sop, Therapeutic Areas, SOP
Education
St. Francis University 1982 — 1986
BS, Science
inVentiv Health Clinical February 2015 - August 2015
PharmaNet/i3 October 2005 - February 2015
PharmaNet November 2002 - October 2005
Phase Forward June 2001 - July 2002
Phase Forward February 2000 - May 2001
PCLC 1995 - 1999
Skills
Clinical Data Management, PL/SQL, Project Management, CDISC, JavaScript, EDC, Training, 21 CFR Part 11, XML, Clinical Development, CRO, Oracle Clinical, GCP, Clinical Trials, CTMS
Education
Mercer County Community College
Certificate in Photography, Photography
Old Dominion University
Bachelor’s Degree, Computer Science
Notre Dame High School 1984 — 1988
High School
inVentiv Health Clinical April 2015 - Present
PharmaNet/i3 February 2010 - Present
PharmaNet/i3 October 2008 - February 2010
Eli Lilly and Company August 2007 - October 2008
Eli Lilly and Company May 2001 - August 2007
Walmart March 2002 - April 2005
Skills
Pharmaceutical Industry, gmp, gcp, Global Management, Pharmacists, Clinical Research, Clinical Data Management, Clinical Pharmacology, Quality Assurance, Quality Management, Quality Auditing, Healthcare, Regulatory Agencies, Pharmaceutical..., Strategic Planning, Strategic Financial..., Global Operations, Cross Functional..., Leadership Trainer, Problem Solving, Coaching, Professional Mentoring, CRO, Outsourcing, Communication Skills, Written & Oral..., Networking, Collaboration, Experienced Change Agent, Six Sigma, Protocol, CAPA, GCP, GMP
Education
Purdue University 1997 — 2001
Doctorate of Pharmacy
Vincennes University 1995 — 1997
Associate of Science, Pre-Pharmacy
ICON plc May 2013 - Present
Planet Pharma June 2014 - November 2014
PharmaNet/i3 August 2011 - February 2013
inVentiv Health Clinical August 2011 - February 2012
Aerotek September 2009 - May 2011
Delta Pharma July 2008 - September 2009
Medpace August 2006 - July 2008
Professional Clinical Research June 2002 - July 2006
Crystal Lake Health Center June 2002 - July 2006
First Look Cosmetics June 1997 - December 1999
Skills
GCP, CRO, Endocrinology, CTMS, Protocol, Urology, ICH-GCP, Inform, Medidata, 21 CFR Part 11, Respiratory Disease, Gastrointestinal..., Clinical Research, Clinical Trials
Education
Coschem 2002 — 2004
Cosmetic Science Diploma, Cosmetic Sciences
Stellenbosch University/Universiteit Stellenbosch 1994 — 1996
Bachelor of Science (B.Sc.), Biochemistry
University of Stellenbosch, Stellenbosch 1993 — 1996
Degree: Bachelors, Science
Johnson & Johnson January 2012 - Present
PharmaNet/i3 November 2011 - February 2012
Pharmanet April 2008 - November 2011
Johnson & Johnson February 2006 - April 2008
Johnson & Johnson September 1997 - February 2006
Delta Corporate Services June 1996 - September 1997
Delta Corporate Services September 1993 - June 1996
Skills
HRIS, Global Compensation, Performance Management, Business Process..., Project Management, Portfolio Management, Change Management, Business Analysis, Process Improvement, Vendor Relationships, Vendor Management, Information Technology, PMP, Strategic Human..., Global Human Resources..., Human Resources, SDLC, Executive Pay, Long Term Business..., Business Relationship..., Cross Functional..., Governance, Outsourcing, IT Strategy, Management, Talent Acquisition, Strategy, Leadership, Integration, Employee Relations, Training, Employee Benefits, Interviews, Software Documentation, Temporary Placement, Talent Management, Consulting, Analysis, Program Management, Enterprise Software, Onboarding
Education
Monmouth University 1992 — 1996
MBA, Management
University of South Carolina-Columbia 1985 — 1989
BS, Psychology
Clinipace Worldwide August 2012 - Present
PharmaNet/i3 February 2006 - August 2012
Esoterix 2000 - 2006
Skills
Clinical Trials, Sop, CTMS, Vaccines, CRO, GCP, Protocol, Clinical Research, EDC, Infectious Diseases
Education
The University of Texas at San Antonio
BS, Biology
DAC Patient Recruitment Services (An Imperial Company) November 2012 - Present
PharmaNet/i3 January 2009 - November 2012
PharmaNet/i3 September 2007 - December 2008
A Safe Place March 2007 - September 2007
A Safe Place August 2006 - March 2007
Education
Michigan State University 2002 — 2006
Bachelor's of Arts, Psychology
Novo Nordisk November 2012 - Present
PharmaNet/i3 April 2012 - November 2012
Kforce Clinical Research, Inc. January 2012 - April 2012
Kforce Clinical Research, Inc. February 2011 - December 2011
Kforce Clinical Research, Inc. September 2010 - January 2011
Kforce Clinical Research, Inc. July 2008 - August 2010
Merck June 2000 - June 2008
Southeastern Cardiovascular Institute 1993 - 1995
Revlon 1990 - 1992
Skills
Clinical Trial..., GCP, Clinical Research, CRO, Clinical Trials, Operational Excellence, Requirements Analysis, Resource Allocation, Training Delivery, Process Improvement, Computer Proficiency, Databases, Timely Delivery, Communication Skills, Site Selections, Patient Recruitment, CTMS, Diabetes, Inform, CRF design, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research..., Drug Development, EDC, Endocrinology, ICH-GCP, Infectious Diseases, Oncology, Oracle Clinical, Pharmacovigilance, Protocol, Regulatory Submissions, Therapeutic Areas, Vaccines
Education
University of Alabama at Birmingham 1986 — 1987
BA, Communication Arts
The University of Georgia 1983 — 1986
BA, Communication Arts
inVentiv Health November 2014 - Present
Quintiles (via Aerotek) September 2012 - November 2014
PharmaNet/i3 February 2011 - September 2012
ReSearch Pharmaceutical Services April 2010 - July 2010
MedFocus December 2007 - March 2010
Merck June 2004 - October 2007
Merck May 2001 - June 2004
University of Pennsylvania School of Medicine February 2000 - May 2001
Skills
Clinical Trials, Clinical Research, Trial Management, Osteoarthritis, Clinical Monitoring, EDC, CTMS, GCP, Clinical Operations, Clinical Data Management, Neuroscience, Smoking Cessation, Depression, Diabetic Neuropathy, Low Back Pain, Insomnia, Overactive Bladder, Multiple Sclerosis, Medical Writing, Medical Devices, Gastrointestinal..., Remote Monitoring, SAE Reconciliation, Site Initiation, Site Closure, Site Management, Enrollment Management, Patient Recruitment, Vendor Management, Study Monitoring, Query Writing, Query Resolution, Oncology, Cardiovascular, Renal
Education
Temple University 2002 — 2004
Certificate, Clinical Trials Management
Penn State University 1997 — 1999
BS, Psychology as a Health Science
Pharmacyclics December 2013 - Present
PAREXEL September 2012 - November 2013
Aerotek May 2012 - September 2012
PharmaNet/i3 December 2007 - May 2012
PPD April 2005 - November 2007
PPD June 2004 - April 2005
PPD December 2002 - June 2004
Skills
Oncology, Clinical Research, Clinical Monitoring, Therapeutic areas, ICH-GCP, CRO, EDC, Infectious Diseases, Research, Neurology, Outlook, Excel, SOP, Urology, Word, PowerPoint, Oracle Clinical, Phase I, Crohn's Disease, Chronic Kidney Disease, Therapeutic Areas, IRB, Clinical Data Management, Informed Consent, GCP, Clinical Trials, Sop, CRF design, CTMS, Clinical Research..., Regulatory Submissions, Clinical Development
Education
St. Edward's University 1996 — 2001
Bachelor of Science, Biology
PharmaNet/i3 December 2011 - July 2012
PharmaNet/i3 July 2009 - November 2011
SIRO Clinpharm Pvt. Ltd. 2006 - 2009
Skills
CRF design, ICH-GCP, EDC, Oracle Clinical, Clinical Data Management, Data Validation, CRO, GCP, 21 CFR Part 11, MedDRA, OC RDC, Data Management, Clinical Trials, Oncology, Inform, Validation, Pharmaceutical Industry
Education
Narsee Monjee Institute of Management Studies 2008 — 2011
Part time_MBA, Human Resources
Welingkar Institute of Management 2007 — 2008
Diploma in Business Management
Bombay College of Pharmacy 2001 — 2005
Bachelors of Pharmaceutical sciences, Pharmaceutical
inVentiv Health Clinical September 2013 - September 2014
Advanced Clinical July 2012 - April 2013
PharmaNet/i3 January 2012 - June 2012
Celgene October 2010 - December 2011
Abraxis BioScience June 2008 - October 2010
Abbott Laboratories February 2007 - February 2008
Duke University Medical Center December 1999 - January 2005
Skills
Bilingual-Spanish, High Volume Discrepancy..., Rescue Studies, Data Collection, Lab Vendor Management, Clinical Trials, Oracle Clinical, EDC, Oncology, Clinical Data Management
Education
North Carolina State University 1994 — 1998
Bachelor of Science, Zoology/Pre-med
inVentiv Health Clinical March 2015 - Present
inVentiv Health Clinical July 2013 - March 2015
inVentiv Health Clinical April 2012 - July 2013
PharmaNet/i3 June 2011 - April 2012
i3, a UnitedHealth Group Company March 2008 - June 2011
Premier Research Group 2006 - 2008
SCIREX Corporation 2002 - 2006
Skills
GCP, Quality Assurance, CRO, Clinical Trials, ICH-GCP, Sop, 21 CFR Part 11, Pharmaceutical Industry, CTMS, EDC
Education
St. Edward's University 1998 — 2001
Bachelor's degree, Health Care Administration
PharmaNet/i3 August 2006 - Present
PharmaNet/i3 December 2003 - July 2006
PharmaNet/i3 August 2001 - December 2003
Drug Emporium July 1990 - August 2001
Skills
CRO, Clinical Development, Clinical Trials, GCP, Clinical Monitoring, CTMS, ICH-GCP
Education
Temple University 2002 — 2007
MS, QA/RA
University of Pittsburgh 1985 — 1990
BS, Pharmacy
inVentiv Health Clinical January 2013 - Present
INC Research November 2012 - January 2013
PharmaNet/i3 October 2011 - November 2012
i3 Statprobe July 2010 - October 2011
US Census Bureau March 2010 - June 2010
Jovial LLC June 2006 - January 2009
PPD 2001 - 2005
Covance 1994 - 1997
Skills
Inform, Clinical Data Management, EDC, Oracle Clinical, Clinical Trials, GCP, CRO
Education
St. Edward's University 1998 — 2000
MBA, Business Administration
Sucampo Pharmaceuticals, Inc. June 2015 - Present
Amgen February 2012 - May 2015
PharmaNet/i3 February 2010 - February 2012
Skills
Statistics, SAS programming, Biostatistics, Statistical Modeling, Qualitative Research, SAS, Quantitative Analytics, Statistical Programming, Clinical Research, CDISC, Pharmaceutical Industry, Data Management, R, Analysis, Clinical Trials, Microsoft Office, Management, Research, SAS Programming, Data Analysis
Education
Michigan State University 2007 — 2009
Master's, Statistics, Actuarial Science
National Kaohsiung Normal University 2002 — 2007
Dual Bachelor of Science, Physics, Industrial Technology Education
PharmaNet/i3 December 2012 - Present
PAREXEL July 2012 - November 2012
PharmaNet/i3 June 2001 - July 2012
Skills
Oracle Clinical, EDC, Clinical Data Management, CRO, CRF design, GCP, CTMS, Medidata, Clinical Trials, Inform, ICH-GCP, Clinical Development, Oncology, Data Management
Education
The College of New Jersey 1997 — 2001
BSN, RN, Nursing
AbbVie July 2015 - Present
HHS/NDMS/DMORT Region II April 2009 - Present
AbbVie May 2014 - July 2015
AbbVie/Inventiv March 2013 - May 2014
PharmaNet/i3 November 2005 - December 2012
i3 Research 2003 - 2004
Skills
Clinical Monitoring, EDC, CTMS, Drug Safety, GCP, CRO, ICH-GCP, Site Management, Clinical Trials, Oncology, Regulatory Affairs, Oracle Clinical, Therapeutic Areas, Sop, Vaccines, Infectious Diseases, FDA, Neurology, Clinical Study Design, Hematology, Diabetes, Cardiology, Dermatology, GLP, Central Nervous System, Medical Devices, GMP, Hypertension, Asthma, Clinical Operations, Clinical Data Management, Regulatory Submissions, Clinical Development, Protocol, Pharmacovigilance, Drug Development, Endocrinology, Clinical Research, Clinical Research..., 21 CFR Part 11, Pharmaceutical Industry, Data Management, Pharmaceutics, Regulatory Requirements, Medicine
Education
University of Florida 2002 — 2004
Master's degree, Forensic Toxicology
Penn State University 1995 — 1998
Bachelor's degree, Science
Novo Nordisk November 2013 - Present
Bayer HealthCare April 2013 - Present
PharmaNet/i3 September 2008 - March 2013
Bristol-Myers Squibb November 2004 - September 2008
Kelly Scientific Merck & Co. April 2004 - October 2004
ICON Clinical Research, Inc. February 2000 - April 2004
Wyeth-Ayerst Research Laboratories February 1995 - February 2000
Skills
Clinical Data Management, Medical Coding, EDC, Oncology, CRO, Pharmaceuticals, GCP, Oracle Clinical RDC, Inform, RAVE, Edit Check Validation, Laboratory Data, metabolics, CNS, Infectious Diseases, Clinical Trials, Medidata, Data Management, Clinical Research, Phase Forward InForm, CRF design, Clinical Development
Education
Temple University 1978 — 1983
Bachelor of Science, Medical Technology
St Huber's Catholic High School for Girls 1974 — 1978
Diploma, Academic, Second Honors all four years
Bristol-Myers Squibb December 2013 - Present
PharmaNet/i3 April 2012 - December 2013
KForce May 2008 - June 2012
Quintiles July 2007 - April 2008
Point Therapeutics January 2006 - April 2007
Antigenics March 2003 - January 2006
InfoMedics January 2000 - March 2003
Skills
Clinical Trials, Oncology, Ophthalmology, Infectious Diseases, Hematology, Pharmaceutical Industry, GCP, Biotechnology, Clinical Research, CTMS, CRO, Quality Assurance
Education
Salem State University 2000 — 2002
BS, Biology
UMass Amherst 1998 — 2000
Animal Sciences
ACT Oncology June 2014 - Present
ACT Oncology February 2008 - June 2014
GlaxoSmithKline July 2003 - February 2008
PharmaNet/i3 September 1999 - July 2003
Rhone-Poulenc Rorer July 1995 - September 1999
BioPharm/IBAH October 1994 - July 1995
Sterling Winthrop Pharmaceuticals May 1992 - October 1994
Skills
Operations Management, Research, Analysis, Process Improvement, International Project..., Oncology, Clinical Development, Strategy, Clinical Trials, EDC, Drug Development, Clinical Research, GCP, Clinical Data Management, CRO, Quality Assurance, Regulatory Submissions, ICH-GCP, Therapeutic Areas, CTMS, Clinical Monitoring
Education
Villanova University 1990 — 1992
Master of Science (M.S.), Biology
Saint Joseph's University 1986 — 1990
Bachelor of Science (B.S.), Biology
InVentiv Health Clinical July 2012 - Present
PharmaNet/i3 February 2011 - July 2012
i3 Research October 2006 - February 2011
SCIREX December 1991 - October 2006
Education
The University of Texas at Austin 1985 — 1989
BS, Science
GCE Solutions Inc. January 2015 - Present
DOCS May 2013 - December 2014
PharmaNet/i3 October 2010 - May 2013
Wyeth Pharmaceuticals 2008 - 2010
Eli Lilly September 2002 - January 2008
Skills
Clinical Trials, Oncology, CTMS, Clinical Development, Biostatistics, Clinical Data Management, Survival Analysis, CRO, EDC, Drug Development, Medical Writing, SAS, CDISC, Data Management, Infectious Diseases, Pharmaceutical Industry, Therapeutic Areas, Outcomes Research, FDA, Regulatory Submissions, Statistical Programming, Clinical Research, GCP, Clinical Study Design, ICH-GCP, SAS programming, SAS Programming
Education
National University of Singapore 1997 — 2002
Master of Science (MS), Statistics
inVentiv Health Clinical November 2014 - Present
Worldwide Clinical Trials November 2013 - November 2014
Worldwide Clinical Trials, Inc. July 2012 - November 2013
PharmaNet/i3 April 2012 - June 2012
Kforce February 2007 - June 2012
Kforce Clinical Research, Inc. December 2005 - February 2007
OMNICARE CLINICAL RESEARCH June 2001 - December 2005
MEDICAL CENTER CARDIOLOGISTS RESEARCH FOUNDATION 1997 - 2001
University of Louisville,Department of Cardiology & Electrophysiology 1995 - 1997
Summary of Nursing Experience 1969 - 1995
Skills
Clinical Research, Clinical Trials, Training & Development, ICH-GCP, Clinical Trial..., Mentoring, Compliance, Presentation Development, Investigator Site..., Nursing Administration, CTMS, Site Management, Cardiology, Clinical Operations, Employee Training, Infectious Diseases, Oracle Clinical, Protocol, GCP, Nursing, Clinical Development, CRO, Clinical Monitoring
Education
The George Washington University School of Medicine and Health Sciences 2000 — 2004
MSHS, Clinical Research
The Johns Hopkins University 1966 — 1969
RN/Diploma, Nursing
Phlexglobal December 2014 - Present
PharmaNet/i3 April 2012 - July 2014
PharmaNet/i3 September 2006 - April 2012
i3 Research February 2006 - September 2006
Skills
Sop, Validation, Pharmaceutical Industry, CTMS, GCP, Clinical Trials, Software Documentation, Research, Oncology, CRO, SAS, Regulatory Affairs, Regulatory Documentation, Clinical Development, ICH-GCP, 21 CFR Part 11, EDC, Documentum, Regulatory Submissions, Therapeutic Areas, Clinical Data Management, Electronic Document, Quality Assurance, Protocol, Computer System..., FDA, Management, SOP, Clinical Research, Data Management, Document Management, Leadership, Biotechnology, Microsoft Office, Infectious Diseases, Life Sciences, Process Improvement, Pharmacovigilance
Education
Syracuse University 1992 — 1996
Communications
Morris Hills High School
Covance October 2013 - Present
PharmaNet/i3 October 2012 - October 2013
Pharmanet, Inc. July 2005 - October 2012
Pharmanet, Inc. July 2004 - July 2005
Merck 2003 - 2004
Eli Lilly July 2002 - October 2003
Skills
Clinical Data Management, EDC, CRO, Inform, RAVE
Education
Osmania University
MBA, Marketing
INC Research March 2015 - Present
inVentivHealth Clinical 2014 - February 2015
PharmaNet/i3 2012 - 2014
BioCryst Pharmaceuticals 2009 - 2012
GlaxoSmithKline 1998 - 2009
Charleston Area Medical Center Health System 1995 - 1998
West Virginia University, Charleston Division 1995 - 1998
West Virginia University, Charleston Division 1995 - 1998
Skills
Infectious Diseases, Drug Development, Clinical Research and..., HIV/AIDS, Influenza and other..., Clinical Trials Phase 1..., IND submission, NDA submission, NDA approval, Medical Affairs, Product Lifecycle..., Clinical Safety and..., Publication,..., Clinical Research, Clinical Trials, Drug Discovery, Pharmaceutical Industry, Lifesciences, CRO, Medicine, Internal Medicine, Virology, Clinical Pharmacology, Clinical Monitoring, Healthcare, Epidemiology, Therapeutic Areas, Clinical Development, Clinical Study Design, Medical Writing, Oncology, Protocol, Vaccines, Life Sciences
Education
Johns Hopkins School of Medicine
Infectious Diseases Fellowship, Infectious Diseases Fellowship Program
Marshall University
Internal Medicine Residency, Internal Medicine Residency Program
University of San Carlos, Guatemala
MD, Medicine and surgery
Health Decisions October 2013 - Present
Aptiv Solutions April 2012 - Present
PharmaNet/i3 April 2010 - April 2012
Kendle International September 2007 - April 2010
Rogers Benefit Group June 2005 - September 2007
Kraze Speed Equipment August 1994 - February 2005
Stop & Shop Co, Inc June 1985 - August 1994
Skills
CRO, CTMS, Business Development, Clinical Trials, Proposal Writing, Budgets, Management, Pharmaceutical Industry, Clinical Development, ICH-GCP, EDC, Oncology, GCP, Clinical Monitoring, Biotechnology, Clinical Research
Education
Providence College
MBA, Business
Providence College
BS, Health Services Administration/Biology
Blue Cottage Consulting, Inc. February 2015 - Present
inVentiv Health Clinical 2014 - 2015
C2B, LLC March 2010 - 2013
PharmaNet/i3 February 2012 - July 2012
Accenture January 2008 - July 2008
Integrated Design, Inc. August 1997 - February 2000
MarketPlace Solutions February 1995 - August 1997
Skills
Building Relationships, Oral & Written..., Intuition, Problem Solving, Project Management, Training, High level of initiative, Visual Communication, Presentations, Technical Support, Technical Writing, PowerPoint, Customer Satisfaction, Business Development, Coordination, Proposal Writing, Analysis, Business Process, Leadership, Marketing, Integration, Management, Management Consulting, Account Management, Strategic Planning, Program Management, Process Improvement, Public Speaking, Customer Service
Education
Michigan State University
Bachelor of Arts (BA), Marketing
Oakland University
Post-baccalaureate, European History
Shire Human Genetic Therapies Inc March 2013 - Present
PharmaNet/i3 October 2012 - Present
Biogen Idec October 2012 - January 2013
Shire HGT July 2012 - October 2012
Shire HGT March 2012 - July 2012
Beth Israel Deaconess Medical Center August 2009 - March 2012
Rolmax Law Office May 2006 - September 2006
Anhui High People’s Court May 2005 - September 2005
Skills
Westlaw certified in..., Westlaw certified in..., Westlaw certified..., Research, Legal Research, Project Management, Outsourcing and..., Human Subject Research..., Investigator Initiated..., Clinical Trials, Medical Affairs, Pharmaceutical Industry, Life Sciences, Lifesciences, Management, Regulatory Affairs, Leadership, Biopharmaceuticals, Biotechnology, Clinical Development, Contract Management
Education
Suffolk University Law School 2009 — 2013
JD, Law
Suffolk University Law School 2008 — 2009
L.L.M., International Bussiness Law
AbbVie July 2013 - Present
PharmaNet/i3 April 2012 - July 2013
Kforce Inc. September 2011 - April 2012
Paragon Biomedical 2008 - 2011
Orthofix May 2007 - December 2008
Texas Dermatology Research Institute 2003 - 2007
Education
The George Washington University School of Medicine and Health Sciences
Masters, Health Sciences - Clinical Research Administration
University of Alberta
Bachelor Science, Nursing
University of Alberta
Bachelor, Business
Eli Lilly and Company January 2014 - Present
PharmaNet/i3 March 2009 - Present
Abbott Laboratories June 2006 - December 2006
Skills
Clinical Data Management, Clinical Trials, SAS programming, SAS, Pharmaceutical Industry, Oncology, CTMS, Biostatistics, Validation, CRF design, SDTM, Statistical Programming
Education
West Virginia University 2003 — 2005
Statistics
Marshall University 2001 — 2002
Information systems
Bayer HealthCare June 2015 - Present
Bayer HealthCare September 2013 - Present
PharmaNet/i3 October 2010 - September 2013
Alpha Stat Inc February 2010 - September 2010
Heptronik Corporation October 2007 - July 2010
Belmaks July 2005 - December 2006
New Horizons Computer Learning Center; Nepal June 2004 - June 2005
Skills
SAS, SAS/SQL, Data Management, SAS programming, Clinical Data Management, CDISC, CRO, EDC, GCP, 21 CFR Part 11, Pharmaceutical Industry, Oracle Clinical, Clinical Trials, Validation, Leadership, Biostatistics, Statistical Programming, SAS Base, ICH-GCP, Inform, SAS Certified Base..., Statistics, SDTM, Clinical Research, CTMS, Data Mining, Statistical Modeling, Clinical Development, Regulatory Submissions, SAS Programming, Logistic Regression
Education
Maulana Azad National Institute of Technology 2000 — 2004
BE, Computer
Maharani Gayatri Devi 1998 — 2000
High School
PRA International November 2012 - Present
PharmaNet/i3 February 2009 - November 2012
INC Research 2007 - 2009
MDS Pharma Services 2002 - 2007
Skills
CRO, CTMS, Clinical Trials, EDC, Clinical Development, ICH-GCP, Therapeutic Areas, 21 CFR Part 11, Pharmaceutical Industry, Sop, Clinical Research, Infectious Diseases
Education
University of Windsor 1987 — 1989
BSc, Biology
Mohawk College 1983 — 1986
Diploma, Medical Laboratory Technology
PharmaNet/i3 June 2007 - Present
JnJ PRD 2004 - 2007
sanofi-aventis 2003 - 2004
Aventis 2000 - 2003
Skills
Medical Writing, Regulatory Submissions, Medical Communications, Publication Planning, GCP, Scientific..., Oncology, Clinical Development, Clinical Trials, Therapeutic Areas, Neuroscience, Team Management
Education
Rutgers University-New Brunswick 1994 — 2000
PhD, neuroscience
PharmaNet/i3 July 2011 - Present
inVentiv Clinical Solutions May 2010 - June 2011
ICON Clinical Research October 2006 - May 2010
ICON Development Solutions March 2004 - October 2006
CCS Associates, Inc November 2000 - February 2004
Skills
Medical Writing, Management, Pharmaceutical Industry, GCP, Cross-functional Team..., CRO, Therapeutic Areas, Protocol, Clinical Trials, Oncology, Regulatory Submissions, Biotechnology, Process Improvement, Medical Devices, Regulatory Affairs, Clinical Development, NDA, Pharmacovigilance, Sop, Vaccines, Clinical Study Design, Drug Development, CTMS, ICH-GCP, Lifesciences, Infectious Diseases, FDA, IND, Clinical Research
Education
The Johns Hopkins University 1984 — 1990
PhD, Biochemical Toxicology
Virginia Polytechnic Institute and State University 1979 — 1984
BS, Biochemistry
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
Citeline, Inc. July 2015 - Present
Citeline, Inc. August 2013 - July 2015
Covance February 2012 - July 2013
PharmaNet/i3 November 2010 - January 2012
Fillo Factory, Inc. July 2010 - November 2010
Skills
GCP, CRO, Pharmaceutical Industry, CTMS, Clinical Trials, Regulatory Requirements, EDC, Clinical Data Management, ICH-GCP
Education
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2010
BS, Nutrition
CinSUG July 2013 - Present
PharmaSUG 2013 - Present
Experis October 2012 - Present
Midwest SAS Users Group (MWSUG) 2005 - Present
PAREXEL April 2012 - October 2012
PharmaNet/i3 June 2009 - April 2012
dunnhumby 2006 - 2009
Kendle International 2000 - 2006
Skills
CDISC, Clinical Trials, Validation, SAS programming, Data Management, Statistics, Pharmaceutical Industry, Data Analysis, Statistical Programming, Oracle Clinical, CRO, ETL, Clinical Data Management, SQL, Databases, Biostatistics, Data Validation, Programming, CRF design, Data Integration, SDTM, Data Mining, Statistical Modeling, 21 CFR Part 11, Business Intelligence, GCP, Oncology, Clinical Study Design, Clinical Development, Protocol, Logistic Regression, Regulatory Submissions, ICH-GCP, SAS Programming, SAS Base
Education
Miami University 1997 — 1999
Master's degree, Statistics
Northern Kentucky University 1993 — 1997
Bachelor's degree, Mathematics and Computer Science
Allergan February 2015 - Present
Allergan October 2014 - February 2015
Allergan July 2012 - October 2014
PharmaNet/i3 2012 - July 2012
Kforce Clinical Research, Inc. 2011 - 2012
Novo Nordisk Inc. 2009 - 2011
Novo Nordisk Inc. 2006 - 2009
Novo Nordisk Inc. 2000 - 2006
Novo Nordisk Inc. 1997 - 2000
Roche Bioscience 1995 - 1997
Skills
CTMS, GCP, Clinical Trials, ICH-GCP, CRO, Clinical Development, Pharmaceutical Industry, Clinical Monitoring, SOP, EDC, Therapeutic Areas, Protocol
Education
San Jose State University
Masters of Arts, Health Science
San Jose State University
Bachelor of Science, Nutritional Science
PharmaNet/i3 August 2010 - Present
Eli Lilly and Company June 2002 - September 2010
Skills
Pharmaceutical Industry, Clinical Trials
Education
Purdue University 1998 — 2002
Bachelor of Science (B.S.), Computer Technology/Computer Systems Technology
PharmaNet/i3 April 2012 - Present
INC Research February 2011 - April 2012
PPD INC,TX September 2010 - February 2011
Hurley Consulting Associates Ltd. January 2008 - September 2010
Skills
CDISC, Oracle Clinical, SAS, Clinical, Unix, Statistical Programming, Clinical Data Management, PL/SQL, CRO, Clinical Trials, Clinical Research, SAS/SQL, Oncology, Pharmaceuticals, Windows, Programming, Validation, Base SAS Certified
Education
Louisiana tech university
Masters, in nano biotechnology (engineering related)
NTR University of Health Sciences
BHMS, Medicine
inVentiv Health January 2009 - Present
PharmaNet/i3 1999 - Present
PharmaNet/i3 February 1999 - December 2008
Smith Hanley Holding February 1999 - December 2008
Rhyan Management 1996 - 1999
American Book Display 1993 - 1996
Publications International 1993 - 1996
Harlem Furniture 1992 - 1993
SJ Smith 1990 - 1992
S.J. Smith 1989 - 1992
Skills
PeopleSoft, Excel, Problem Solving, Analysis, Accounts Receivable, Business Analysis, Payroll, HRIS, Word, Accounting, Financial Reporting, Accounts Payable, Customer Relations, Requirements Analysis, Auditing, Mentoring, Project Planning, Inventory Management, Billing, Internal Audit, ERP, Interviewing, Coaching, Research, Data Analysis, Budgeting, Account Reconciliation, Query Tool, Integration, Microsoft Excel, Budgets, Finance, Databases, General Ledger, Financials, Process Improvement, Access, Sarbanes-Oxley Act, Hyperion Enterprise, Crystal Reports, Business Process..., Oracle Applications, Financial Analysis, Variance Analysis, PeopleTools, Invoicing, Interviews
Education
University of Illinois Springfield (Formerly Sangamon State) 1989 — 1992
Bachelor of Science (BS), Accounting
Richland Community College 1987 — 1989
Associate's degree, Accounting
Quintiles September 2014 - Present
State of Arizona September 2013 - 2014
Ascent Services Group contracted to Diaiichi Sankyo March 2013 - September 2013
InFaith 2009 - 2013
Actelion 2007 - 2009
Sanofi 2006 - 2007
PharmaNet/i3 2004 - 2006
AstraZeneca 2002 - 2004
PharmaNet 1997 - 2002
American Missionary Fellowship 1980 - 1995
Skills
Clinical Trials, Oncology, GCP, Pharmaceutical Industry, Clinical Development, EDC, CTMS, Infectious Diseases, Clinical Research, Protocol, Clinical Data Management, CRO, Sop, Cross-functional Team..., Preaching, Pastoral Care, Volunteer Management, Theology, Therapeutic Areas, Nonprofits, Diabetes, Clinical Monitoring, Drug Development, Biopharmaceuticals, Medical Writing, Medical Affairs, Regulatory Submissions, Pharmacovigilance, Dermatology, Data Management, Clinical Study Design, Clinical Operations, Cardiology, FDA, Vaccines, ICH-GCP, SOP
Education
Thomas Jefferson University 1990 — 1993
BSN, Nursing
St. Joseph's University 1983 — 1985
MBA, Administrative Management
Warner Pacific College 1972 — 1974
BS, Business
Bristol-Myers Squibb September 2003 - Present
PharmaNet/i3 September 1998 - September 2003
Johnson & Johnson 1996 - 1998
Johns Hopkins Bloomberg School of Public Health 1993 - 1996
Skills
Clinical Trials, Clinical Development, Oncology, Pharmaceutical Industry, 21 CFR Part 11, Biotechnology, CDISC, Regulatory Submissions, SAS, Biostatistics
Education
The Johns Hopkins University 1991 — 1993
MS, Statistics
Shandong University 1984 — 1989
PhD, Applied Mathematics
inVentiv Health Clinical May 2013 - Present
PharmaNet/i3 July 2011 - May 2013
Synteract, Inc. December 2006 - July 2011
Skills
Clinical Data Management, EDC, GCP, Clinical Development, Data Management, 21 CFR Part 11, Statistics, SAS Programming, Biotechnology, SAS, Statistical Programming, SAS Base
Education
San Diego State University-California State University 2005 — 2007
MS, Statistics
Purdue University 1998 — 2002
BS, Industrial Management
GfK Custom Research North America June 2013 - Present
PharmaNet/i3 January 2009 - May 2013
PharmaNet Inc. November 2006 - December 2008
PharmaNet Inc. July 2002 - November 2006
PharmaNet February 2002 - March 2002
Stull Technologies November 1998 - August 2001
BWD Automotive, (formerly General Automotive) August 1994 - October 1998
Christian Care Center September 1993 - May 1994
Victor C. Neumann September 1993 - May 1994
Tirriana, Inc June 1992 - August 1993
Skills
Payroll, Benefits Administration, Employee Benefits, HRIS, Human Resources, Deferred Compensation, Microsoft Excel, Process Improvement, Training, Performance Management, Management, Personnel Management, Accounts Payable, Interviews, Accounts Receivable, Payroll Taxes, Onboarding, New Hire Orientations
Education
Moody Bible Institute
BA, Elementary Education; Computer Applications
Taylor Business Institute
Certificate of Completion, Secretarial Science
inVentiv Health Clinical August 2012 - Present
PharmaNet/i3 January 2008 - August 2012
PharmaNet January 2005 - January 2008
Education
Northwestern University 1998 — 2002
BA, Psychology, Gender Studies
inVentiv Health Clinical November 2008 - Present
PharmaNet/i3 November 2008 - July 2012
Eli Lilly and Company June 1998 - October 2008
State of Indiana June 1989 - June 1998
State of Indiana, Department of Information Technology 1982 - 1989
Skills
Statistical Programming, Clinical Trials, Pharmaceutical Industry
Education
Purdue University - Krannert School of Management
B.S., Management; Marketing
Manual High School
PharmaNet/i3 February 2008 - February 2012
Cosentino North America / US Stone July 2004 - February 2008
Kobelco America, Inc July 1999 - July 2003
GMAC Commercial Finance (General Motors) June 1985 - June 1999
Skills
Credit, Credit Risk, Credit Portfolio..., Treasury Management, Corporate Finance, Corporate Treasury, Cash Management, PeopleSoft, Risk Management, Customer Service, Accounts Receivable, Financial Analysis, Month end close
Education
St. Edward's University Austin Texas
The University of Texas at Austin
Novartis 2008 - Present
Schering-Plough 2006 - 2008
PharmaNet/i3 2003 - 2006
Covance Periapproval Services 2002 - 2003
Princeton Radiology 2001 - 2002
Education
College of St. Elizabeth 2010 — 2013
Masters, Healthcare Management
Richard Stockton College of New Jersey 1994 — 1998
Bachelor of Science (B.S.), Biology, General
Pharmanet/i3 June 2007 - Present
C2R 2000 - 2007
Otsuka Pharmaceutical Co., Ltd 1993 - 2000
Education
The Johns Hopkins University 1997 — 1999
MS, Biotechnology
Texas A&M University 1980 — 1982
BS, Zoology
inVentiv Health Clinical November 2013 - Present
inVentiv Health Clinical June 2012 - October 2013
PharmaNet/i3 December 2005 - June 2012
Skills
EDC, Clinical Data Management, Oracle Clinical, CDISC, ICH-GCP, CTMS, CRO, Clinical Monitoring, Pharmaceutical Industry, GCP, CRF design, Clinical Trials, Clinical Development, 21 CFR Part 11
Education
Michigan State University 1996 — 2001
Bachelor Science, Human Biology
PharmaNet/i3 November 2012 - Present
Kforce October 1998 - October 2012
Kern McNeill International July 1996 - October 1998
Skills
Research, Clinical Research, Microsoft Office, English, Microsoft Excel, Clinical Trials, Microsoft Word, PowerPoint, Pharmaceutical Industry, Customer Service, GCP, Budgets
Education
The George Washington University School of Medicine and Health Sciences 2008 — 2010
Master of Science (M.Sc.), Health Science (Clinical Research Administration)
University of Minnesota-Twin Cities 1980 — 1986
Bachelor of Arts (BA), Clinical Psychology
PharmaNet/i3 March 2012 - Present
Kforce Inc. April 2011 - March 2012
Kforce Inc. March 2008 - April 2011
INC Research January 2007 - March 2008
INC Research February 2006 - January 2007
PPD May 2005 - February 2006
Education
Texas State University-San Marcos 2002 — 2004
Bachelor of Science (BS), Biology, General