Clinsys Clinical Research
Industry: Company
DescriptionFounded: 1992 Parent organization: Jubilant Life Sciences Subsidiary: TrialStat Corporation
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Clinsys Clinical Research Employees
Employee
Years
Job
Industry
Aaron Latta Aaron Latta's Clinsys Clinical Research Experience June 2008 - March 2010
Job Associate Project Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL November 2014 - Present
PAREXEL February 2013 - November 2014
PAREXEL August 2010 - February 2013
Clinsys Clinical Research June 2008 - March 2010
i3 Research May 2006 - June 2008
Novocell April 2005 - May 2006
Ortho-McNeil Pharmaceutical March 2003 - April 2005
Merck March 2001 - March 2003
TAP Pharmaceuticals January 2000 - March 2001
Skills
Clinical Development, Project Management, Licensing, Cross-functional Team..., Biopharmaceuticals, Product Development, Pharmaceutical Industry, Infectious Diseases, Dermatology, Biotechnology, Gastroenterology, CNS disorders, Pharmaceutical Sales, Endocrinology, Diabetes, CTMS, Clinical Trials, Therapeutic Areas, CRO, Clinical Monitoring
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2007 — 2009
MBA
University of Miami 1991 — 1995
BS, Biology
PAREXEL November 2014 - Present
PAREXEL February 2013 - November 2014
PAREXEL August 2010 - February 2013
Clinsys Clinical Research June 2008 - March 2010
i3 Research May 2006 - June 2008
Novocell April 2005 - May 2006
Ortho-McNeil Pharmaceutical March 2003 - April 2005
Merck March 2001 - March 2003
TAP Pharmaceuticals January 2000 - March 2001
Skills
Clinical Development, Project Management, Licensing, Cross-functional Team..., Biopharmaceuticals, Product Development, Pharmaceutical Industry, Infectious Diseases, Dermatology, Biotechnology, Gastroenterology, CNS disorders, Pharmaceutical Sales, Endocrinology, Diabetes, CTMS, Clinical Trials, Therapeutic Areas, CRO, Clinical Monitoring
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2007 — 2009
MBA
University of Miami 1991 — 1995
BS, Biology
David Maggipinto David Maggipinto's Clinsys Clinical Research Experience 2003 - 2006
Job Controller at John Yurconic Agency
Industry Accounting
Experience
John Yurconic Agency September 2013 - Present
Avantor Performance Materials, Inc. 2012 - 2012
Brown and Brown Insurance 2006 - 2011
Clinsys Clinical Research 2003 - 2006
The PHOENIX 1994 - 2003
Skills
Accounting, Ledger, Accruals, Month End, Journal Entries, Year End Close, Accounting Analysis, Depreciation, Intercompany, Internal Controls, GAAP, Segregation of Duties, Revenue Recognition, Payroll, Accounts Receivable, Auditing, General Ledger, Hyperion Enterprise, Sarbanes-Oxley Act, Year-end Close, Budgets, Fixed Assets, Forecasting, Sarbanes-Oxley, Financial Statements, Financial Reporting, Process Improvement, Accounts Payable, Financial Analysis, Analysis, Managerial Finance
Education
DeSales University 1989 — 1993
Bachelors, Accounting
John Yurconic Agency September 2013 - Present
Avantor Performance Materials, Inc. 2012 - 2012
Brown and Brown Insurance 2006 - 2011
Clinsys Clinical Research 2003 - 2006
The PHOENIX 1994 - 2003
Skills
Accounting, Ledger, Accruals, Month End, Journal Entries, Year End Close, Accounting Analysis, Depreciation, Intercompany, Internal Controls, GAAP, Segregation of Duties, Revenue Recognition, Payroll, Accounts Receivable, Auditing, General Ledger, Hyperion Enterprise, Sarbanes-Oxley Act, Year-end Close, Budgets, Fixed Assets, Forecasting, Sarbanes-Oxley, Financial Statements, Financial Reporting, Process Improvement, Accounts Payable, Financial Analysis, Analysis, Managerial Finance
Education
DeSales University 1989 — 1993
Bachelors, Accounting
Harish Gowda Harish Gowda's Clinsys Clinical Research Experience September 2007 - October 2008
Job Operations Manager (CDM & DB Programming) at Cognizant Technology Solutions Private Ltd
Industry Pharmaceuticals
Experience
Cognizant Technology Solutions Private Ltd April 2015 - Present
Cognizant Technology Solutions May 2014 - March 2015
Cognizant Technology Solutions October 2013 - March 2014
Cognizant Technology Solutions Denmark ApS February 2010 - September 2013
Cognizant Technology Solutions December 2008 - February 2010
Clinsys Clinical Research September 2007 - October 2008
Quintiles Technologies Pvt Ltd August 2006 - July 2007
Accenture Services Pvt Ltd March 2003 - August 2006
Skills
International Project..., Transition Management, Recruitment Life..., New Business Development, Business Development, Management, Due Diligence, Project Management, Process Improvement, Clinical Data Management, Six Sigma, Team Management, Business Analysis, Change Management, Clinical Trials, Data Management, GCP, Leadership, CRM, Strategy, ICH-GCP, CRO, Databases
Education
National Institute of Business Management 2014 — 2014
Master of Business Administration (MBA), Operations Management, First
Society of Clinical Data Management 2014 — 2014
Certified Clinical Data Manager, Clinical Data Management, License No 16742
Bangalore University 1994 — 1997
B Sc, Physics, Chemistry, Maths
Cognizant Technology Solutions Private Ltd April 2015 - Present
Cognizant Technology Solutions May 2014 - March 2015
Cognizant Technology Solutions October 2013 - March 2014
Cognizant Technology Solutions Denmark ApS February 2010 - September 2013
Cognizant Technology Solutions December 2008 - February 2010
Clinsys Clinical Research September 2007 - October 2008
Quintiles Technologies Pvt Ltd August 2006 - July 2007
Accenture Services Pvt Ltd March 2003 - August 2006
Skills
International Project..., Transition Management, Recruitment Life..., New Business Development, Business Development, Management, Due Diligence, Project Management, Process Improvement, Clinical Data Management, Six Sigma, Team Management, Business Analysis, Change Management, Clinical Trials, Data Management, GCP, Leadership, CRM, Strategy, ICH-GCP, CRO, Databases
Education
National Institute of Business Management 2014 — 2014
Master of Business Administration (MBA), Operations Management, First
Society of Clinical Data Management 2014 — 2014
Certified Clinical Data Manager, Clinical Data Management, License No 16742
Bangalore University 1994 — 1997
B Sc, Physics, Chemistry, Maths
Lindsay Finnegan Lindsay Finnegan's Clinsys Clinical Research Experience April 2008 - February 2010
Job Sr. Clinical Contracts Specialist at Premier Research
Industry Pharmaceuticals
Experience
Premier Research March 2015 - Present
inVentiv Health Clinical April 2013 - March 2015
PRA International May 2011 - October 2011
PRA International January 2010 - May 2011
Clinsys Clinical Research April 2008 - February 2010
The University of Mississippi Foundation August 2006 - May 2007
The University of Mississippi January 2006 - May 2006
Skills
Clinical Trials, GCP, Clinical Research, CRO, CTMS, Regulatory Submissions, Leadership, Clinical Data Management, Protocol, ICH-GCP, FDA, EDC, Data Management, IRB, Sop, Clinical Monitoring, Clinical Development, Regulatory Requirements, Regulatory Affairs, Pharmaceutical Industry, SOP
Education
University of Mississippi 2006 — 2007
MA, Higher Education/ Student Personnel
University of Mississippi 2001 — 2005
BA, English
Premier Research March 2015 - Present
inVentiv Health Clinical April 2013 - March 2015
PRA International May 2011 - October 2011
PRA International January 2010 - May 2011
Clinsys Clinical Research April 2008 - February 2010
The University of Mississippi Foundation August 2006 - May 2007
The University of Mississippi January 2006 - May 2006
Skills
Clinical Trials, GCP, Clinical Research, CRO, CTMS, Regulatory Submissions, Leadership, Clinical Data Management, Protocol, ICH-GCP, FDA, EDC, Data Management, IRB, Sop, Clinical Monitoring, Clinical Development, Regulatory Requirements, Regulatory Affairs, Pharmaceutical Industry, SOP
Education
University of Mississippi 2006 — 2007
MA, Higher Education/ Student Personnel
University of Mississippi 2001 — 2005
BA, English
Prasad Muppirala Prasad Muppirala's Clinsys Clinical Research Experience January 2010 - December 2010
Job Healthcare Technologist
Industry Health, Wellness and Fitness
Experience
Independent December 2010 - Present
Lumināt November 2012 - July 2013
Clinsys Clinical Research January 2010 - December 2010
Express Scripts 2008 - January 2010
Savanna Health, Inc. June 2008 - October 2009
RedBrick Health March 2007 - July 2008
RAJEN Technology Solutions, Inc. April 2002 - March 2007
BORN Information Services, Inc. August 1995 - April 2002
BullPower Systems August 1990 - April 1993
Skills
Technical Architecture, Product Strategy, Product Development, Healthcare IT, PBM, Disease Management, Healthcare Management, Road Maps, Product Innovation, Technological Innovation, IT Strategy, IT Outsourcing, Start-up Environments, Scrum, Software Development..., Agile Project Management, Lifestyle Management, Team Leadership, Technical Leadership, Enterprise Architecture, Product Management, Architecture, Pharmacy Benefit..., Healthcare Information..., Start-up Environment, Agile Methodologies, SOA, Business Analysis, Java Enterprise Edition, Oracle, Strategy, Solution Architecture, Architectures, Web Services, Healthcare Analytics, Integration
Education
Northwestern University - Kellogg School of Management
MBA, General Management, Marketing Strategy
Minnesota State University, Mankato
MS, Computer Science
Andhra University
B.Engg, Electronics & Communication Engineering
Viswa Bharati English Medium High School
Independent December 2010 - Present
Lumināt November 2012 - July 2013
Clinsys Clinical Research January 2010 - December 2010
Express Scripts 2008 - January 2010
Savanna Health, Inc. June 2008 - October 2009
RedBrick Health March 2007 - July 2008
RAJEN Technology Solutions, Inc. April 2002 - March 2007
BORN Information Services, Inc. August 1995 - April 2002
BullPower Systems August 1990 - April 1993
Skills
Technical Architecture, Product Strategy, Product Development, Healthcare IT, PBM, Disease Management, Healthcare Management, Road Maps, Product Innovation, Technological Innovation, IT Strategy, IT Outsourcing, Start-up Environments, Scrum, Software Development..., Agile Project Management, Lifestyle Management, Team Leadership, Technical Leadership, Enterprise Architecture, Product Management, Architecture, Pharmacy Benefit..., Healthcare Information..., Start-up Environment, Agile Methodologies, SOA, Business Analysis, Java Enterprise Edition, Oracle, Strategy, Solution Architecture, Architectures, Web Services, Healthcare Analytics, Integration
Education
Northwestern University - Kellogg School of Management
MBA, General Management, Marketing Strategy
Minnesota State University, Mankato
MS, Computer Science
Andhra University
B.Engg, Electronics & Communication Engineering
Viswa Bharati English Medium High School
Jill Awe Jill Awe's Clinsys Clinical Research Experience November 2008 - March 2009
Job Executive Assistant at Genworth Mortgage Insurance
Industry Insurance
Experience
Genworth Mortgage Insurance July 2012 - Present
Genworth Financial June 2009 - July 2012
Clinsys Clinical Research November 2008 - March 2009
GlaxoSmithKline July 1999 - October 2008
Brea Canon Oil Co 1990 - 1996
Mobil Oil Exploration & Production US April 1989 - May 1990
Skills
Outlook, Process Improvement, Project Management, Visio
Education
Long Beach City College 1986 — 1990
Business
Genworth Mortgage Insurance July 2012 - Present
Genworth Financial June 2009 - July 2012
Clinsys Clinical Research November 2008 - March 2009
GlaxoSmithKline July 1999 - October 2008
Brea Canon Oil Co 1990 - 1996
Mobil Oil Exploration & Production US April 1989 - May 1990
Skills
Outlook, Process Improvement, Project Management, Visio
Education
Long Beach City College 1986 — 1990
Business
Greg Dodds Greg Dodds's Clinsys Clinical Research Experience 2004 - 2009
Job Director, Business Development at Vince & Associates
Industry Pharmaceuticals
Experience
Vince & Associates 2012 - Present
Aptiv Solutions 2011 - 2012
Integrium 2009 - 2011
Clinsys Clinical Research 2004 - 2009
Target Research Associates 2004 - 2009
PAREXEL 1997 - 2000
SMG Marketing Group 1993 - 1997
Skills
Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Medical Devices, Business Development, Proposal Writing, New Business Development
Education
Northwestern University
M.S., Managerial Economics and Decision Science
St. Vincent College
B.S., Economics
Vince & Associates 2012 - Present
Aptiv Solutions 2011 - 2012
Integrium 2009 - 2011
Clinsys Clinical Research 2004 - 2009
Target Research Associates 2004 - 2009
PAREXEL 1997 - 2000
SMG Marketing Group 1993 - 1997
Skills
Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Medical Devices, Business Development, Proposal Writing, New Business Development
Education
Northwestern University
M.S., Managerial Economics and Decision Science
St. Vincent College
B.S., Economics
Caroline Bedard-Nower Caroline Bedard-Nower's Clinsys Clinical Research Experience July 2009 - March 2010
Job Global Sr. Project Manager at ICON plc
Industry Pharmaceuticals
Experience
ICON plc September 2011 - Present
CBN Global Clinical Research, LLC December 2010 - Present
Boeringer Ingelheim Pharmaceutical, Inc. December 2010 - September 2011
The McInnis Companies December 2010 - September 2011
Clinsys Clinical Research July 2009 - March 2010
PAREXEL September 2006 - December 2008
Boehringer Ingelheim Pharmaceuticals, Inc. March 2002 - September 2006
Bristol-Myers Squibb Pharmaceutical Research Institute March 1998 - June 2001
Yale New Haven Hospital October 1996 - March 1998
Medisys Health Group January 1995 - September 1996
Skills
CRO, Clinical Trials, Clinical Research, CTMS, GCP, Therapeutic Areas, Oncology, Cardiology, ICH-GCP, Protocol, FDA, Neurology, SOP, Clinical Development, Pharmaceutical Industry
Education
Université de Montréal 1991 — 1994
BSN, Nursing
ICON plc September 2011 - Present
CBN Global Clinical Research, LLC December 2010 - Present
Boeringer Ingelheim Pharmaceutical, Inc. December 2010 - September 2011
The McInnis Companies December 2010 - September 2011
Clinsys Clinical Research July 2009 - March 2010
PAREXEL September 2006 - December 2008
Boehringer Ingelheim Pharmaceuticals, Inc. March 2002 - September 2006
Bristol-Myers Squibb Pharmaceutical Research Institute March 1998 - June 2001
Yale New Haven Hospital October 1996 - March 1998
Medisys Health Group January 1995 - September 1996
Skills
CRO, Clinical Trials, Clinical Research, CTMS, GCP, Therapeutic Areas, Oncology, Cardiology, ICH-GCP, Protocol, FDA, Neurology, SOP, Clinical Development, Pharmaceutical Industry
Education
Université de Montréal 1991 — 1994
BSN, Nursing
Samuel Wilson's Clinsys Clinical Research Experience February 2008 - April 2009
Job Associate HECOR Statistics Director at Astellas Pharma
Industry Biotechnology
Experience
Astellas Pharma May 2015 - Present
Theorem Clinical Research July 2014 - April 2015
Theorem Clinical Research February 2013 - July 2014
Clinipace Worldwide July 2010 - February 2013
PharPoint Research, Inc. April 2009 - July 2010
Clinsys Clinical Research February 2008 - April 2009
Hill's Pet Nutrition May 2006 - August 2006
US Army May 1998 - November 2003
Skills
Clinical Trials, SAS, Biostatistics, Clinical Research, Statistics, Clinical Data Management, Statistical Programming, Data Management, Clinical Development, CDISC, CRO, CTMS, EDC, GCP, Protocol, SAS programming, Professional Mentoring, SAS Programming
Education
North Carolina State University 2006 — 2016
PhD, Statistics
Kansas State University 2004 — 2006
MS, Statistics
United States Military Academy at West Point 1994 — 1998
BS, Mathematics
Astellas Pharma May 2015 - Present
Theorem Clinical Research July 2014 - April 2015
Theorem Clinical Research February 2013 - July 2014
Clinipace Worldwide July 2010 - February 2013
PharPoint Research, Inc. April 2009 - July 2010
Clinsys Clinical Research February 2008 - April 2009
Hill's Pet Nutrition May 2006 - August 2006
US Army May 1998 - November 2003
Skills
Clinical Trials, SAS, Biostatistics, Clinical Research, Statistics, Clinical Data Management, Statistical Programming, Data Management, Clinical Development, CDISC, CRO, CTMS, EDC, GCP, Protocol, SAS programming, Professional Mentoring, SAS Programming
Education
North Carolina State University 2006 — 2016
PhD, Statistics
Kansas State University 2004 — 2006
MS, Statistics
United States Military Academy at West Point 1994 — 1998
BS, Mathematics
Cheryl Victor RN, CCRA Cheryl Victor RN, CCRA's Clinsys Clinical Research Experience November 2005 - April 2007
Job Clinical Trial Manager at PRA Health Sciences
Industry Research
Experience
PRA Health Sciences September 2015 - Present
Clinipace Worldwide March 2014 - August 2015
University of Missouri November 2011 - March 2014
Jubilant Clinsys Inc. (formerly Clinsys Clinical Research) April 2007 - November 2011
Clinsys Clinical Research November 2005 - April 2007
Clinsys Clinical Research October 2001 - November 2005
Ellis Fischel Cancer Center January 1994 - October 2001
Skills
Lung, Oncology, Melanoma, Pain Management, Clinical Trials, GCP, Pediatrics, EDC, Clinical Research, Data Management, Therapeutic Areas, CRO, Clinical Development, ICH-GCP, Cancer, FDA, Pharmaceutical Industry, CTMS, Dermatology, Clinical Monitoring, Phase I, Nursing, Clinical Data Management, Infectious Diseases, Protocol, Drug Development, Treatment, Clinical Study Design, Regulatory Affairs, Sop, Asthma, Patient Recruitment, Biotechnology, Clinical Operations, Lifesciences, Medical Writing, Neurology, Pharmacovigilance, Regulatory Submissions, SOP, Life Sciences
Education
Columbia College 1994 — 1996
ADN, Nursing
Columbia Public Schools Licensed Practical Nursing Program 1992 — 1993
LPN, Nursing
PRA Health Sciences September 2015 - Present
Clinipace Worldwide March 2014 - August 2015
University of Missouri November 2011 - March 2014
Jubilant Clinsys Inc. (formerly Clinsys Clinical Research) April 2007 - November 2011
Clinsys Clinical Research November 2005 - April 2007
Clinsys Clinical Research October 2001 - November 2005
Ellis Fischel Cancer Center January 1994 - October 2001
Skills
Lung, Oncology, Melanoma, Pain Management, Clinical Trials, GCP, Pediatrics, EDC, Clinical Research, Data Management, Therapeutic Areas, CRO, Clinical Development, ICH-GCP, Cancer, FDA, Pharmaceutical Industry, CTMS, Dermatology, Clinical Monitoring, Phase I, Nursing, Clinical Data Management, Infectious Diseases, Protocol, Drug Development, Treatment, Clinical Study Design, Regulatory Affairs, Sop, Asthma, Patient Recruitment, Biotechnology, Clinical Operations, Lifesciences, Medical Writing, Neurology, Pharmacovigilance, Regulatory Submissions, SOP, Life Sciences
Education
Columbia College 1994 — 1996
ADN, Nursing
Columbia Public Schools Licensed Practical Nursing Program 1992 — 1993
LPN, Nursing
Marion Lorden's Clinsys Clinical Research Experience March 2008 - November 2009
Job Project Manager at BTG Canada International, Inc.
Industry Medical Devices
Experience
BTG Canada International, Inc. July 2013 - Present
PMI _ OVOC 2005 - Present
Nordion, Inc. April 2011 - July 2013
Consultant November 2009 - March 2011
Clinsys Clinical Research March 2008 - November 2009
TrialStat March 2008 - November 2008
Coley Pharmaceutical Group November 2007 - February 2008
Coley Pharmaceutical Group January 2006 - November 2007
Coley Pharmaceutical Group January 2004 - December 2005
Coley Pharmaceutical Group December 2001 - December 2003
Skills
Project Management, Outsourcing Management, Business Process..., Outsourcing, Clinical Trials, Vendor Relationships, Vendor Contracts, PMO, Management, Leadership, Start-ups, Cross-functional Team..., Team Building, Proposal Writing, CRO, MS Project, Program Management, Clinical Development, Biotechnology, Pharmaceutical Industry, Microsoft Project
Education
Algonquin College of Applied Arts and Technology 2001 — 2004
Project Management
BTG Canada International, Inc. July 2013 - Present
PMI _ OVOC 2005 - Present
Nordion, Inc. April 2011 - July 2013
Consultant November 2009 - March 2011
Clinsys Clinical Research March 2008 - November 2009
TrialStat March 2008 - November 2008
Coley Pharmaceutical Group November 2007 - February 2008
Coley Pharmaceutical Group January 2006 - November 2007
Coley Pharmaceutical Group January 2004 - December 2005
Coley Pharmaceutical Group December 2001 - December 2003
Skills
Project Management, Outsourcing Management, Business Process..., Outsourcing, Clinical Trials, Vendor Relationships, Vendor Contracts, PMO, Management, Leadership, Start-ups, Cross-functional Team..., Team Building, Proposal Writing, CRO, MS Project, Program Management, Clinical Development, Biotechnology, Pharmaceutical Industry, Microsoft Project
Education
Algonquin College of Applied Arts and Technology 2001 — 2004
Project Management
S Clayton Shapiro S Clayton Shapiro's Clinsys Clinical Research Experience June 2004 - February 2009
Job Sr CRA at PAREXEL
Industry Research
Experience
PAREXEL March 2010 - Present
RPS May 2009 - February 2010
Clinsys Clinical Research June 2004 - February 2009
Volt Technical Service July 2002 - June 2004
MDS Pharma Services-Phoenix International October 1999 - July 2002
Baylor College of Medicine December 1998 - October 1999
HCRN/Montrose Clinic May 1996 - November 1998
Education
Minnesota Intercollegiate Nursing Consortium 1988 — 1990
Nursing, Nursing
University of Missouri-Kansas City 1986 — 1987
BA, BS, biology Chemistry
University of Missouri-Kansas City School of Medicine 1982 — 1987
Medicine
Francis Howel High School 1978 — 1982
HS grad
PAREXEL March 2010 - Present
RPS May 2009 - February 2010
Clinsys Clinical Research June 2004 - February 2009
Volt Technical Service July 2002 - June 2004
MDS Pharma Services-Phoenix International October 1999 - July 2002
Baylor College of Medicine December 1998 - October 1999
HCRN/Montrose Clinic May 1996 - November 1998
Education
Minnesota Intercollegiate Nursing Consortium 1988 — 1990
Nursing, Nursing
University of Missouri-Kansas City 1986 — 1987
BA, BS, biology Chemistry
University of Missouri-Kansas City School of Medicine 1982 — 1987
Medicine
Francis Howel High School 1978 — 1982
HS grad
James Gunter James Gunter's Clinsys Clinical Research Experience February 2007 - November 2009
Job Director of Dedicated Biometrics Services at Chiltern International
Industry Pharmaceuticals
Experience
Chiltern International October 2012 - Present
FileONE December 2010 - October 2012
Independent February 2010 - December 2010
Clinsys Clinical Research February 2007 - November 2009
INC Research April 2006 - February 2007
Cavu Corporation February 2001 - April 2002
PharmaResearch June 1996 - February 2001
Skills
Project Management, SDLC, Data Management, EDC, Database Administration, ETL, Business Intelligence, Leadership, Business Process..., IT Management, GCP, Data Analysis, SaaS, Databases, Operations Management, CRO, SAS programming, CRM, Cross-functional Team..., 21 CFR Part 11, Enterprise Software, CTMS, Biostatistics, Oracle Clinical, Clinical Development, Clinical Data Management, Clinical Trials, Regulatory Submissions, ICH-GCP, Protocol, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science, Biology
Chiltern International October 2012 - Present
FileONE December 2010 - October 2012
Independent February 2010 - December 2010
Clinsys Clinical Research February 2007 - November 2009
INC Research April 2006 - February 2007
Cavu Corporation February 2001 - April 2002
PharmaResearch June 1996 - February 2001
Skills
Project Management, SDLC, Data Management, EDC, Database Administration, ETL, Business Intelligence, Leadership, Business Process..., IT Management, GCP, Data Analysis, SaaS, Databases, Operations Management, CRO, SAS programming, CRM, Cross-functional Team..., 21 CFR Part 11, Enterprise Software, CTMS, Biostatistics, Oracle Clinical, Clinical Development, Clinical Data Management, Clinical Trials, Regulatory Submissions, ICH-GCP, Protocol, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science, Biology
Andrea Axtell's Clinsys Clinical Research Experience February 2011 - October 2011
Job Clinical Safety Specialist at Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. October 2011 - Present
Clinsys Clinical Research February 2011 - October 2011
Quintiles November 2009 - March 2011
Quintiles April 2009 - October 2009
Quintiles August 2006 - March 2009
Thomson Learning, Inc. July 2003 - August 2006
Red Hat June 2002 - July 2003
SAS April 2001 - May 2002
The Dialog Corporation January 2001 - March 2001
West Group, Inc. August 1998 - January 2001
Skills
Project Management, Business Development, Process Improvement, Clinical Trials, Management, Proposal Writing, CRO, Budgets, Analysis, Training, Marketing, Project Planning, Sales, Sales Operations, GCP, Strategy
Education
University of North Carolina at Chapel Hill 1988 — 1992
BAs, Psychology and Anthropology
Novella Clinical, Inc. October 2011 - Present
Clinsys Clinical Research February 2011 - October 2011
Quintiles November 2009 - March 2011
Quintiles April 2009 - October 2009
Quintiles August 2006 - March 2009
Thomson Learning, Inc. July 2003 - August 2006
Red Hat June 2002 - July 2003
SAS April 2001 - May 2002
The Dialog Corporation January 2001 - March 2001
West Group, Inc. August 1998 - January 2001
Skills
Project Management, Business Development, Process Improvement, Clinical Trials, Management, Proposal Writing, CRO, Budgets, Analysis, Training, Marketing, Project Planning, Sales, Sales Operations, GCP, Strategy
Education
University of North Carolina at Chapel Hill 1988 — 1992
BAs, Psychology and Anthropology
Janice Flynn-Bailey Janice Flynn-Bailey's Clinsys Clinical Research Experience January 2005 - November 2007
Job Senior Clinical Research Associate at Evaheart
Industry Biotechnology
Experience
Evaheart July 2014 - Present
Integrium 2008 - Present
Bailey & Bailey Clinical Research Services January 2006 - Present
Contract CRA, Bailey and Bailey Clinical Services May 2003 - Present
Clinipace Worldwide CRO February 2014 - August 2014
Montreal Heart Institute October 2009 - March 2014
TFS, INc. December 2012 - April 2013
GE Healthcare 2006 - 2008
Clinsys Clinical Research January 2005 - November 2007
PPD June 2004 - February 2006
Skills
CTMS, Clinical Trials, GCP, Clinical Monitoring, EDC, CRO, ICH-GCP, Medical Devices, Clinical Research, Clinical Data Management, Clinical Research..., Therapeutic Areas, Clinical Development, Pharmaceutical Industry, Cardiology, Oncology, Clinical Operations
Education
Saint Louis University 1980 — 1984
Bachelor of Science (BS), Human Biology, 3.3
Evaheart July 2014 - Present
Integrium 2008 - Present
Bailey & Bailey Clinical Research Services January 2006 - Present
Contract CRA, Bailey and Bailey Clinical Services May 2003 - Present
Clinipace Worldwide CRO February 2014 - August 2014
Montreal Heart Institute October 2009 - March 2014
TFS, INc. December 2012 - April 2013
GE Healthcare 2006 - 2008
Clinsys Clinical Research January 2005 - November 2007
PPD June 2004 - February 2006
Skills
CTMS, Clinical Trials, GCP, Clinical Monitoring, EDC, CRO, ICH-GCP, Medical Devices, Clinical Research, Clinical Data Management, Clinical Research..., Therapeutic Areas, Clinical Development, Pharmaceutical Industry, Cardiology, Oncology, Clinical Operations
Education
Saint Louis University 1980 — 1984
Bachelor of Science (BS), Human Biology, 3.3
Pam Swinton Pam Swinton's Clinsys Clinical Research Experience October 2002 - February 2009
Job Operational Study Manager
Industry Research
Experience
CRO March 2015 - Present
CRO March 2009 - October 2014
Clinsys Clinical Research October 2002 - February 2009
Gap International May 2000 - October 2002
American Red Cross April 1997 - May 2000
Skills
CRO, Clinical Trials, Pharmaceutical Industry, EDC, GCP, Project Management, Research, Highly motivated..., ICH-GCP, Microsoft Office, Cross-functional Team..., Highly detail oriented, Protocol, Customer Service, Driving Results, Team-oriented, Sop, Site Management, Organization, Supervisory Experience, Clinical Monitoring, Organizational..., Organizational...
Education
Saint Joseph's University 2013 — 2015
Master of Science (M.S.), Organizational Leadership & Development / Dynamics, 4.0
Widener University 2009 — 2012
Bachelor of Arts (B.A.), Psychology, 3.86
Community Collegeof Philadelphia 2004 — 2008
Associate of Arts and Sciences (A.A.S.), Behavioral Health / Human Services, 3.91
CRO March 2015 - Present
CRO March 2009 - October 2014
Clinsys Clinical Research October 2002 - February 2009
Gap International May 2000 - October 2002
American Red Cross April 1997 - May 2000
Skills
CRO, Clinical Trials, Pharmaceutical Industry, EDC, GCP, Project Management, Research, Highly motivated..., ICH-GCP, Microsoft Office, Cross-functional Team..., Highly detail oriented, Protocol, Customer Service, Driving Results, Team-oriented, Sop, Site Management, Organization, Supervisory Experience, Clinical Monitoring, Organizational..., Organizational...
Education
Saint Joseph's University 2013 — 2015
Master of Science (M.S.), Organizational Leadership & Development / Dynamics, 4.0
Widener University 2009 — 2012
Bachelor of Arts (B.A.), Psychology, 3.86
Community Collegeof Philadelphia 2004 — 2008
Associate of Arts and Sciences (A.A.S.), Behavioral Health / Human Services, 3.91
Nermina Nakas's Clinsys Clinical Research Experience December 2007 - February 2008
Job Senior Medical Director, Medical and Scientific Affairs at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical October 2014 - Present
ClinTec International June 2014 - September 2014
Jubilant Clinsys May 2012 - May 2014
Jubilant Clinsys (formerly Clinsys Clinical Research) May 2011 - April 2012
Jubilant Clinsys (FORMERLY CLINSYS CLINICAL RESEARCH) June 2009 - April 2011
JUBILANT CLINSYS (FORMERLY CLINSYS CLINICAL RESEARCH) March 2008 - May 2009
CLINSYS CLINICAL RESEARCH December 2007 - February 2008
CLINSYS (PREVIOUSLY TARGET RESEARCH ASSOCIATES) March 2006 - November 2007
Skills
Clinical Trials, Clinical Research, Drug Safety, Clinical Development, Infectious Diseases, CTMS, GCP, Oncology, CRO, Therapeutic Areas, EDC, Pharmaceutical Industry, Pharmacovigilance, Medical Affairs, Protocol, Clinical Monitoring, ICH-GCP, Clinical Data Management, Clinical Operations, Dermatology, Drug Development, Regulatory Submissions, Medical Writing, Clinical Study Design, Sop, Regulatory Affairs, IND, Pharmacology, FDA, Hematology, Biotechnology, Neurology, Diabetes, Biostatistics, Immunology, Oracle Clinical, Clinical Pharmacology, Lifesciences, Endocrinology, SOP
Education
Eastern Virginia Medical School
Master of Public Health (M.P.H.), Epidemiology
PEDIATRIC CLINIC UNIVERSITY HOSPITAL
PEDIATRICIAN, Pediatrics Residency Program
MEDICAL SCHOOL UNIVERSITY OF SARAJEVO
MEDICAL DOCTOR, Medicine
inVentiv Health Clinical October 2014 - Present
ClinTec International June 2014 - September 2014
Jubilant Clinsys May 2012 - May 2014
Jubilant Clinsys (formerly Clinsys Clinical Research) May 2011 - April 2012
Jubilant Clinsys (FORMERLY CLINSYS CLINICAL RESEARCH) June 2009 - April 2011
JUBILANT CLINSYS (FORMERLY CLINSYS CLINICAL RESEARCH) March 2008 - May 2009
CLINSYS CLINICAL RESEARCH December 2007 - February 2008
CLINSYS (PREVIOUSLY TARGET RESEARCH ASSOCIATES) March 2006 - November 2007
Skills
Clinical Trials, Clinical Research, Drug Safety, Clinical Development, Infectious Diseases, CTMS, GCP, Oncology, CRO, Therapeutic Areas, EDC, Pharmaceutical Industry, Pharmacovigilance, Medical Affairs, Protocol, Clinical Monitoring, ICH-GCP, Clinical Data Management, Clinical Operations, Dermatology, Drug Development, Regulatory Submissions, Medical Writing, Clinical Study Design, Sop, Regulatory Affairs, IND, Pharmacology, FDA, Hematology, Biotechnology, Neurology, Diabetes, Biostatistics, Immunology, Oracle Clinical, Clinical Pharmacology, Lifesciences, Endocrinology, SOP
Education
Eastern Virginia Medical School
Master of Public Health (M.P.H.), Epidemiology
PEDIATRIC CLINIC UNIVERSITY HOSPITAL
PEDIATRICIAN, Pediatrics Residency Program
MEDICAL SCHOOL UNIVERSITY OF SARAJEVO
MEDICAL DOCTOR, Medicine
Christopher W. Gregory Christopher W. Gregory's Clinsys Clinical Research Experience March 2008 - May 2011
Job General Manager at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions February 2014 - Present
Catalent Pharma Solutions May 2012 - Present
University of North Carolina March 2004 - Present
Jubilant Clinsys May 2011 - April 2012
Clinsys Clinical Research March 2008 - May 2011
Clinsys Clinical Research September 2007 - February 2008
Voyager Pharmaceutical Corporation December 2005 - August 2007
Voyager Pharmaceutical Corporation November 2004 - December 2005
Voyager Pharmaceutical Corporation January 2004 - November 2004
University of North Carolina March 2002 - December 2003
Skills
Medicine, Biotechnology, Clinical Trials, Lifesciences, Oncology, Clinical Research, Medical Writing, Drug Discovery, Protocol, Therapeutic Areas, CRO, Cancer, CTMS
Education
The Ohio State University College of Medicine 1988 — 1993
PhD, Anatomy
Concord College 1984 — 1988
BS, Biology
Catalent Pharma Solutions February 2014 - Present
Catalent Pharma Solutions May 2012 - Present
University of North Carolina March 2004 - Present
Jubilant Clinsys May 2011 - April 2012
Clinsys Clinical Research March 2008 - May 2011
Clinsys Clinical Research September 2007 - February 2008
Voyager Pharmaceutical Corporation December 2005 - August 2007
Voyager Pharmaceutical Corporation November 2004 - December 2005
Voyager Pharmaceutical Corporation January 2004 - November 2004
University of North Carolina March 2002 - December 2003
Skills
Medicine, Biotechnology, Clinical Trials, Lifesciences, Oncology, Clinical Research, Medical Writing, Drug Discovery, Protocol, Therapeutic Areas, CRO, Cancer, CTMS
Education
The Ohio State University College of Medicine 1988 — 1993
PhD, Anatomy
Concord College 1984 — 1988
BS, Biology
Dave Stern Dave Stern's Clinsys Clinical Research Experience 2008 - 2009
Job Founder at Life Science Solutions, LLC
Industry Biotechnology
Experience
Life Science Solutions 2011 - Present
ECCRO India 2010 - 2011
Clinsys Clinical Research 2008 - 2009
INC Research July 2004 - November 2008
Beardsworth Consulting Group March 2003 - July 2004
Research Testing Labs March 1999 - March 2003
Skills
CRO, Biotechnology, Medical Devices, Life Sciences, Clinical Trials, Start-ups, Healthcare, Contract Negotiation, Oncology, Clinical, Clinical Research, Pharmaceuticals, Negotiation, Executive Management, Cross-functional Team..., New Business Development, Proposal Writing, Budgeting, Strategic Planning, Business Strategy, Marketing Strategy, Business Planning, Clinical Development, CTMS, Pharmaceutical Industry, Lifesciences, Business Development, Budgets, Management, GCP, Cardiology, Biopharmaceuticals, Infectious Diseases, Pharmaceutics, Drug Development, Commercialization, FDA, Regulatory Affairs, Medical Writing, Neurology
Education
Benedictine University
MBA, Health Administration
Northern Illinois University
BS, Marketing
Life Science Solutions 2011 - Present
ECCRO India 2010 - 2011
Clinsys Clinical Research 2008 - 2009
INC Research July 2004 - November 2008
Beardsworth Consulting Group March 2003 - July 2004
Research Testing Labs March 1999 - March 2003
Skills
CRO, Biotechnology, Medical Devices, Life Sciences, Clinical Trials, Start-ups, Healthcare, Contract Negotiation, Oncology, Clinical, Clinical Research, Pharmaceuticals, Negotiation, Executive Management, Cross-functional Team..., New Business Development, Proposal Writing, Budgeting, Strategic Planning, Business Strategy, Marketing Strategy, Business Planning, Clinical Development, CTMS, Pharmaceutical Industry, Lifesciences, Business Development, Budgets, Management, GCP, Cardiology, Biopharmaceuticals, Infectious Diseases, Pharmaceutics, Drug Development, Commercialization, FDA, Regulatory Affairs, Medical Writing, Neurology
Education
Benedictine University
MBA, Health Administration
Northern Illinois University
BS, Marketing
Linda Lipani's Clinsys Clinical Research Experience July 2009 - July 2010
Job Counselor, Personal Life Coach
Industry Mental Health Care
Experience
Self Employed August 2012 - Present
Clinsys Clinical Research July 2009 - July 2010
Contracted to Pharmalink September 2007 - March 2009
Contract Monitoring for Quintiles 2006 - 2007
SCIREX Corporation May 2005 - August 2006
PRA International July 2002 - May 2005
Education
Lynchburg College 1986 — 1988
BS, M.Ed, Health Sciences, Education
Virginia Baptist Hospital School of Nursing 1974 — 1977
RN, Nursing
Self Employed August 2012 - Present
Clinsys Clinical Research July 2009 - July 2010
Contracted to Pharmalink September 2007 - March 2009
Contract Monitoring for Quintiles 2006 - 2007
SCIREX Corporation May 2005 - August 2006
PRA International July 2002 - May 2005
Education
Lynchburg College 1986 — 1988
BS, M.Ed, Health Sciences, Education
Virginia Baptist Hospital School of Nursing 1974 — 1977
RN, Nursing
Rajagopalan Srinivasan Rajagopalan Srinivasan's Clinsys Clinical Research Experience August 2007 - October 2008
Job Chief Statistical Consultant, Independent Private Statistical Consultancy
Industry Pharmaceuticals
Experience
Independent Private Statistical Consultancy January 2010 - Present
Boden Inc October 2008 - November 2009
Clinsys Clinical Research August 2007 - October 2008
Clinsys Clinical Research Organization 2007 - 2008
INC Research 2000 - 2007
Education
The University of Georgia 1983 — 1985
Ph.D, Sstatistics
Florida State University 1980 — 1983
M.S., Statistics
University of Madras 1979 — 1980
M.Phil, Statistics
University of Madras 1960 — 1961
M.A., Statistics & Mathematics
University of Madras 1957 — 1960
B.Sc. (Hons), Statistics & Mathematics
Independent Private Statistical Consultancy January 2010 - Present
Boden Inc October 2008 - November 2009
Clinsys Clinical Research August 2007 - October 2008
Clinsys Clinical Research Organization 2007 - 2008
INC Research 2000 - 2007
Education
The University of Georgia 1983 — 1985
Ph.D, Sstatistics
Florida State University 1980 — 1983
M.S., Statistics
University of Madras 1979 — 1980
M.Phil, Statistics
University of Madras 1960 — 1961
M.A., Statistics & Mathematics
University of Madras 1957 — 1960
B.Sc. (Hons), Statistics & Mathematics
Laurie Hunt, CCRA Laurie Hunt, CCRA's Clinsys Clinical Research Experience April 2004 - December 2005
Job Consultant, Clinical Research Associate at Synteract, Inc.
Industry Pharmaceuticals
Experience
SynteractHCR, Inc. February 2012 - Present
ZymoGenetics/BMS October 2004 - Present
Serenity Pharmaceuticals January 2009 - November 2014
IBSA December 2008 - April 2009
Kendle International December 2005 - November 2008
Clinsys Clinical Research April 2004 - December 2005
Ferring Pharmaceuticals October 1999 - January 2004
Boehringer Mannheim 1993 - 1998
IBRD 1991 - 1998
Boehringer Mannheim 1989 - 1991
Education
The Johns Hopkins University 1984 — 1988
B.S, Business Management/Leadership
SynteractHCR, Inc. February 2012 - Present
ZymoGenetics/BMS October 2004 - Present
Serenity Pharmaceuticals January 2009 - November 2014
IBSA December 2008 - April 2009
Kendle International December 2005 - November 2008
Clinsys Clinical Research April 2004 - December 2005
Ferring Pharmaceuticals October 1999 - January 2004
Boehringer Mannheim 1993 - 1998
IBRD 1991 - 1998
Boehringer Mannheim 1989 - 1991
Education
The Johns Hopkins University 1984 — 1988
B.S, Business Management/Leadership
Abby Harden Abby Harden's Clinsys Clinical Research Experience April 2008 - March 2010
Job Senior Outsourcing Manager
Industry Pharmaceuticals
Experience
PRA Health Sciences July 2013 - Present
ReSearch Pharmaceutical Services November 2012 - July 2013
Salix Pharmaceuticals April 2011 - November 2012
INC Research May 2010 - April 2011
Clinsys Clinical Research April 2008 - March 2010
PAREXEL October 2006 - March 2008
AmerisourceBergen March 2005 - October 2006
Nortel Networks February 1999 - January 2001
Skills
Clinical Trials, CRO, Clinical Development, Clinical Research, Pharmaceutical Industry, Contract Management, CTMS, GCP, Sales, Biotechnology, Protocol, Oncology, Contract Negotiation, Budgets, Leadership, FDA, Exceptional People..., Financial Analysis, Cross-functional Team..., Outsourcing, Clinical Data Management, Data Management, Sop, Strategy, Training, Forecasting, Proposal Writing, Negotiation, Regulatory Submissions, Medical Devices, Management, Sales Operations, Regulatory Affairs, Business Development, EDC, Infectious Diseases
Education
North Carolina State University 1976 — 1980
BA, Accounting and Business Management
PRA Health Sciences July 2013 - Present
ReSearch Pharmaceutical Services November 2012 - July 2013
Salix Pharmaceuticals April 2011 - November 2012
INC Research May 2010 - April 2011
Clinsys Clinical Research April 2008 - March 2010
PAREXEL October 2006 - March 2008
AmerisourceBergen March 2005 - October 2006
Nortel Networks February 1999 - January 2001
Skills
Clinical Trials, CRO, Clinical Development, Clinical Research, Pharmaceutical Industry, Contract Management, CTMS, GCP, Sales, Biotechnology, Protocol, Oncology, Contract Negotiation, Budgets, Leadership, FDA, Exceptional People..., Financial Analysis, Cross-functional Team..., Outsourcing, Clinical Data Management, Data Management, Sop, Strategy, Training, Forecasting, Proposal Writing, Negotiation, Regulatory Submissions, Medical Devices, Management, Sales Operations, Regulatory Affairs, Business Development, EDC, Infectious Diseases
Education
North Carolina State University 1976 — 1980
BA, Accounting and Business Management
Colin Coffua Colin Coffua's Clinsys Clinical Research Experience October 2006 - June 2008
Job Senior Vice President, Strategic Accounts at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health - Clinical Divison September 2013 - Present
inVentiv Health June 2011 - September 2013
i3 UnitedHealth Group October 2008 - June 2011
Clinsys Clinical Research October 2006 - June 2008
PAREXEL February 2005 - August 2006
eResearch Technology October 2002 - February 2005
Skills
Medical Devices, Clinical Trials, Pharmaceutical Sales, Account Management, Oncology, Pharmaceutical Industry, Interactive Advertising, Cross-functional Team..., Marketing Strategy, Drug Development, Clinical Development, CRO, Business Development
Education
University of Puget Sound 1979 — 1981
MBA, Marketing
Norwich University 1971 — 1975
BS, Business Adminstration
inVentiv Health - Clinical Divison September 2013 - Present
inVentiv Health June 2011 - September 2013
i3 UnitedHealth Group October 2008 - June 2011
Clinsys Clinical Research October 2006 - June 2008
PAREXEL February 2005 - August 2006
eResearch Technology October 2002 - February 2005
Skills
Medical Devices, Clinical Trials, Pharmaceutical Sales, Account Management, Oncology, Pharmaceutical Industry, Interactive Advertising, Cross-functional Team..., Marketing Strategy, Drug Development, Clinical Development, CRO, Business Development
Education
University of Puget Sound 1979 — 1981
MBA, Marketing
Norwich University 1971 — 1975
BS, Business Adminstration
Cindy Patterson Cindy Patterson's Clinsys Clinical Research Experience 2000 - 2008
Job Research Assistant at Slone Partners Diagnostics / Laboratory / Genomics
Industry Staffing and Recruiting
Experience
Slone Partners 2011 - Present
Massillon Public Library 2008 - Present
Clinsys Clinical Research 2000 - 2008
Skills
Clinical Monitoring, GCP, CRO, Clinical Research, EDC, ICH-GCP, Oncology, Hospitals, Pharmacovigilance, Clinical Trials, CTMS, Clinical Development, Therapeutic Areas, FDA, Regulatory Affairs, Phase I, Infectious Diseases, Laboratory, Hematology, Regulatory Submissions, Pharmaceutical Industry, Clinical Data Management, Medical Diagnostics, Medical Devices, Lifesciences, Phlebotomy, Cardiology, Molecular Biology, Biotechnology, Protocol, Hardware Diagnostics, Endocrinology, Cancer, Dermatology, Neurology, Diabetes, Vaccines, Immunology, Drug Development, Gastroenterology, Life Sciences
Education
Kent State University
BSN, Nursing
Slone Partners 2011 - Present
Massillon Public Library 2008 - Present
Clinsys Clinical Research 2000 - 2008
Skills
Clinical Monitoring, GCP, CRO, Clinical Research, EDC, ICH-GCP, Oncology, Hospitals, Pharmacovigilance, Clinical Trials, CTMS, Clinical Development, Therapeutic Areas, FDA, Regulatory Affairs, Phase I, Infectious Diseases, Laboratory, Hematology, Regulatory Submissions, Pharmaceutical Industry, Clinical Data Management, Medical Diagnostics, Medical Devices, Lifesciences, Phlebotomy, Cardiology, Molecular Biology, Biotechnology, Protocol, Hardware Diagnostics, Endocrinology, Cancer, Dermatology, Neurology, Diabetes, Vaccines, Immunology, Drug Development, Gastroenterology, Life Sciences
Education
Kent State University
BSN, Nursing
Tiffany Blakeney, J.D., PhD. Tiffany Blakeney, J.D., PhD.'s Clinsys Clinical Research Experience March 2008 - March 2010
Job Corporate CRA Lead CRA at ICON
Industry Biotechnology
Experience
The EMMES Corporation November 2010 - August 2011
Clinical PRofessionals Network 2009 - 2011
Clinsys Clinical Research March 2008 - March 2010
COVANCE INCORPORATED March 2007 - February 2008
Kendle International December 2005 - February 2007
Chiltern International June 2004 - November 2005
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" June 2003 - June 2004
Phoenix Data Systems October 2002 - June 2003
Bayer CropScience March 2002 - October 2002
PAREXEL - CONTRACT December 2000 - February 2002
Education
Villanova University
UNIVERSITY OF NORTH CAROLINA
North Carolina Central University 1987 — 1991
B.A., Political Science (minor) Life Sciences
The EMMES Corporation November 2010 - August 2011
Clinical PRofessionals Network 2009 - 2011
Clinsys Clinical Research March 2008 - March 2010
COVANCE INCORPORATED March 2007 - February 2008
Kendle International December 2005 - February 2007
Chiltern International June 2004 - November 2005
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" June 2003 - June 2004
Phoenix Data Systems October 2002 - June 2003
Bayer CropScience March 2002 - October 2002
PAREXEL - CONTRACT December 2000 - February 2002
Education
Villanova University
UNIVERSITY OF NORTH CAROLINA
North Carolina Central University 1987 — 1991
B.A., Political Science (minor) Life Sciences
Jessica Hughes Jessica Hughes's Clinsys Clinical Research Experience June 2008 - October 2012
Job Senior Project Manager, Neuroscience Worldwide Clinical Trials
Industry Pharmaceuticals
Experience
Worldwide Clinical Trials September 2013 - Present
Jubilant Clinsys July 2012 - August 2013
Clinsys Clinical Research June 2008 - October 2012
Clinsys Clinical Research February 2001 - June 2008
Skills
Clinical Trials, Clinical Research, ADHD, Depression, Anxiety, Schizophrenia, Bipolar Disorder, Impulsive Aggression, Alzheimer's Disease, Art Therapy
Education
University of Pennsylvania 1999 — 2000
MS, Psychology
University of Connecticut 1994 — 1998
BS, Psychology/Marketing
Worldwide Clinical Trials September 2013 - Present
Jubilant Clinsys July 2012 - August 2013
Clinsys Clinical Research June 2008 - October 2012
Clinsys Clinical Research February 2001 - June 2008
Skills
Clinical Trials, Clinical Research, ADHD, Depression, Anxiety, Schizophrenia, Bipolar Disorder, Impulsive Aggression, Alzheimer's Disease, Art Therapy
Education
University of Pennsylvania 1999 — 2000
MS, Psychology
University of Connecticut 1994 — 1998
BS, Psychology/Marketing
Cindy Holoman, MBA Cindy Holoman, MBA's Clinsys Clinical Research Experience August 2009 - September 2011
Job Clinical Research Manager
Industry Pharmaceuticals
Experience
PRA Health Sciences June 2013 - Present
PRA Health Sciences September 2011 - June 2013
Clinsys Clinical Research August 2009 - September 2011
Novartis Pharmaceuticals July 2006 - May 2008
Novartis Pharmaceuticals December 2004 - July 2006
Royal Doulton October 2000 - January 2004
J.C. Penney July 1994 - March 2000
Skills
PowerPoint, Drug Development, Clinical Trials, Oncology, Regulatory Submissions, Dermatology, Microsoft Excel, Microsoft Office, Protocol, Diabetes, Infectious Diseases, Pharmaceutical Industry, 21 CFR Part 11, CRO, ICH-GCP, GCP, Therapeutic Areas, Clinical Operations, Oracle Clinical, Trial Management, CTMS, EDC, Medical Affairs, Sop, Line Management, Oncology Clinical..., Immunology, Clinical Research
Education
Centenary College 2007 — 2009
Master, Business Administration
Old Dominion University 1989 — 1993
B.S., Communications
PRA Health Sciences June 2013 - Present
PRA Health Sciences September 2011 - June 2013
Clinsys Clinical Research August 2009 - September 2011
Novartis Pharmaceuticals July 2006 - May 2008
Novartis Pharmaceuticals December 2004 - July 2006
Royal Doulton October 2000 - January 2004
J.C. Penney July 1994 - March 2000
Skills
PowerPoint, Drug Development, Clinical Trials, Oncology, Regulatory Submissions, Dermatology, Microsoft Excel, Microsoft Office, Protocol, Diabetes, Infectious Diseases, Pharmaceutical Industry, 21 CFR Part 11, CRO, ICH-GCP, GCP, Therapeutic Areas, Clinical Operations, Oracle Clinical, Trial Management, CTMS, EDC, Medical Affairs, Sop, Line Management, Oncology Clinical..., Immunology, Clinical Research
Education
Centenary College 2007 — 2009
Master, Business Administration
Old Dominion University 1989 — 1993
B.S., Communications
Natasha Ben-Kamara Natasha Ben-Kamara's Clinsys Clinical Research Experience January 2008 - September 2009
Job Senior Clinical Research Associate at SynteractHCR
Industry Pharmaceuticals
Experience
SynteractHCR April 2015 - Present
SynteractHCR September 2014 - March 2015
PAREXEL July 2014 - September 2014
PRA International June 2011 - July 2014
PRA International September 2009 - June 2011
Clinsys Clinical Research January 2008 - September 2009
INC Research September 2006 - August 2007
Ironclad Performance Wear 2001 - 2003
Skills
CRO, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, EDC, GCP, ICH-GCP, Research, Sales
Education
University of North Carolina at Chapel Hill 2005 — 2006
Tulane University 2004 — 2006
MPH
University of Maryland College Park 1997 — 2000
BA
SynteractHCR April 2015 - Present
SynteractHCR September 2014 - March 2015
PAREXEL July 2014 - September 2014
PRA International June 2011 - July 2014
PRA International September 2009 - June 2011
Clinsys Clinical Research January 2008 - September 2009
INC Research September 2006 - August 2007
Ironclad Performance Wear 2001 - 2003
Skills
CRO, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, EDC, GCP, ICH-GCP, Research, Sales
Education
University of North Carolina at Chapel Hill 2005 — 2006
Tulane University 2004 — 2006
MPH
University of Maryland College Park 1997 — 2000
BA
Zia Haque Zia Haque's Clinsys Clinical Research Experience January 2010 - April 2011
Job Global Head, Data Management at Quintiles Real World & Late Phase Research
Industry Pharmaceuticals
Experience
Outcome Quintiles March 2013 - Present
Outcome Quintiles May 2012 - Present
Jubilant Clinsys May 2011 - May 2012
Clinsys Clinical Research January 2010 - April 2011
PharmaNet February 2006 - January 2010
INC Research January 2004 - January 2006
Ascon Health December 2001 - February 2004
PAREXEL January 2001 - December 2001
PPD June 1999 - December 2000
Clintrials Research September 1997 - June 1999
Skills
CRO, Clinical Data Management, EDC, Cross-functional Team..., Clinical Research, 21 CFR Part 11, Business Development, Global Delivery, Oracle Clinical, FDA, Clinical Trials, CTMS, Vendor Management, Data Management, GCP, Pharmaceutical Industry, Inform, Oncology, ICH-GCP, CRF design, Management, Lifesciences, Biostatistics, Therapeutic Areas, Clinical Monitoring, Clinical Development, Life Sciences, Regulatory Submissions, Pharmacovigilance
Education
Bangalore University
BS, Zoology, chemistry
Campbell University
MS, Clinical Research
Karnatak University
MA, English
Outcome Quintiles March 2013 - Present
Outcome Quintiles May 2012 - Present
Jubilant Clinsys May 2011 - May 2012
Clinsys Clinical Research January 2010 - April 2011
PharmaNet February 2006 - January 2010
INC Research January 2004 - January 2006
Ascon Health December 2001 - February 2004
PAREXEL January 2001 - December 2001
PPD June 1999 - December 2000
Clintrials Research September 1997 - June 1999
Skills
CRO, Clinical Data Management, EDC, Cross-functional Team..., Clinical Research, 21 CFR Part 11, Business Development, Global Delivery, Oracle Clinical, FDA, Clinical Trials, CTMS, Vendor Management, Data Management, GCP, Pharmaceutical Industry, Inform, Oncology, ICH-GCP, CRF design, Management, Lifesciences, Biostatistics, Therapeutic Areas, Clinical Monitoring, Clinical Development, Life Sciences, Regulatory Submissions, Pharmacovigilance
Education
Bangalore University
BS, Zoology, chemistry
Campbell University
MS, Clinical Research
Karnatak University
MA, English
Angela Brinson, MSM, PMP's Clinsys Clinical Research Experience December 2008 - Present
Job
Industry Pharmaceuticals
Experience
Clinsys Clinical Research December 2008 - Present
Education
North Carolina State University 1992 — 1996
MSM, Management
University of North Carolina at Chapel Hill 1988 — 1992
BA, Journalism and Mass Communications
Clinsys Clinical Research December 2008 - Present
Education
North Carolina State University 1992 — 1996
MSM, Management
University of North Carolina at Chapel Hill 1988 — 1992
BA, Journalism and Mass Communications
Jenny Britt's Clinsys Clinical Research Experience April 2007 - December 2009
Job Programmer Analyst @GSK at Alphanumeric Systems
Industry Biotechnology
Experience
GSK January 2010 - Present
Clinsys Clinical Research April 2007 - December 2009
GlaxoSmithKline November 2005 - April 2007
Sai People Solutions, Inc. April 2005 - November 2005
INC Research January 2002 - April 2005
etrials Worldwide August 2001 - January 2002
PharmaResearch Corporation September 1999 - August 2001
Quintiles September 1998 - September 1999
Skills
InForm 4.6, Oracle Clinical 4.0/4.5, Clinplus 2.12/3.21, Developer/2000 Form..., Developer/2000 Report..., Etrials iSuite 3.1, InVision 2.6, MS-DOS, Oracle 7.3/8i/9i, SQL, PL/SQL, SQL*Plus, TOAD 8.6.1, SAS 6.12/8.0/9.1, Unix, Visio 4.0/5.0, SQL*Loader, SAS
Education
North Carolina State University 1992 — 1996
BS, Mathematics
GSK January 2010 - Present
Clinsys Clinical Research April 2007 - December 2009
GlaxoSmithKline November 2005 - April 2007
Sai People Solutions, Inc. April 2005 - November 2005
INC Research January 2002 - April 2005
etrials Worldwide August 2001 - January 2002
PharmaResearch Corporation September 1999 - August 2001
Quintiles September 1998 - September 1999
Skills
InForm 4.6, Oracle Clinical 4.0/4.5, Clinplus 2.12/3.21, Developer/2000 Form..., Developer/2000 Report..., Etrials iSuite 3.1, InVision 2.6, MS-DOS, Oracle 7.3/8i/9i, SQL, PL/SQL, SQL*Plus, TOAD 8.6.1, SAS 6.12/8.0/9.1, Unix, Visio 4.0/5.0, SQL*Loader, SAS
Education
North Carolina State University 1992 — 1996
BS, Mathematics
Frank Manto's Clinsys Clinical Research Experience January 2008 - Present
Job Research Assistant for Clinsys Clinical Research, Inc.
Industry Pharmaceuticals
Experience
Clinsys Clinical Research January 2008 - Present
Berkeley College August 2001 - December 2007
Freeman Decorating company August 1998 - July 2001
Education
Berkeley College 1997 — 2006
B.S., Management
Clinsys Clinical Research January 2008 - Present
Berkeley College August 2001 - December 2007
Freeman Decorating company August 1998 - July 2001
Education
Berkeley College 1997 — 2006
B.S., Management
Lori Carman, RN's Clinsys Clinical Research Experience June 2007 - March 2008
Job Senior Director, Clinical Research and Operations at Insmed
Industry Pharmaceuticals
Experience
Insmed, Inc. November 2013 - Present
Mirati Therapeutics July 2013 - November 2013
MethylGene Inc. June 2012 - July 2013
HCR America September 2010 - June 2012
Bristol-Myers Squibb January 2010 - September 2010
Medarex March 2008 - January 2010
Clinsys Clinical Research June 2007 - March 2008
Clinsys Clinical Research March 2006 - May 2007
Target Research Associates March 2005 - March 2006
Target Research Associates 2003 - 2005
Skills
Clinical Trials, GCP, Program Management, Pharmaceutical Industry, Clinical Development, Cross-functional Team..., CRO, FDA, Drug Development, Oncology, Clinical Monitoring, Process Improvement, SOP, Biotechnology, Clinical Research, Therapeutic Areas, CTMS, ICH-GCP, Infectious Diseases, EDC
Education
Mount Vernon Nazarene University 1999 — 2001
Columbus State Community College 1983 — 1987
ADN, Nursing
Hilliard High
Insmed, Inc. November 2013 - Present
Mirati Therapeutics July 2013 - November 2013
MethylGene Inc. June 2012 - July 2013
HCR America September 2010 - June 2012
Bristol-Myers Squibb January 2010 - September 2010
Medarex March 2008 - January 2010
Clinsys Clinical Research June 2007 - March 2008
Clinsys Clinical Research March 2006 - May 2007
Target Research Associates March 2005 - March 2006
Target Research Associates 2003 - 2005
Skills
Clinical Trials, GCP, Program Management, Pharmaceutical Industry, Clinical Development, Cross-functional Team..., CRO, FDA, Drug Development, Oncology, Clinical Monitoring, Process Improvement, SOP, Biotechnology, Clinical Research, Therapeutic Areas, CTMS, ICH-GCP, Infectious Diseases, EDC
Education
Mount Vernon Nazarene University 1999 — 2001
Columbus State Community College 1983 — 1987
ADN, Nursing
Hilliard High
Julie Ball's Clinsys Clinical Research Experience April 2004 - May 2010
Job Senior Director, Clinical Operations at Horizon Pharma, Inc.
Industry Pharmaceuticals
Experience
Horizon Pharma, Inc. June 2010 - Present
Clinsys Clinical Research April 2004 - May 2010
Paragon Biomedical October 1999 - January 2004
G. D. Searle September 1984 - October 1999
Skills
Clinical Development, Clinical Research, Clinical Trials, CRO, Clinical, IND, Pharmaceutical Industry, CTMS, ICH-GCP, Oncology, GCP, Therapeutic Areas, Clinical Monitoring, EDC, Biotechnology, FDA, Infectious Diseases, Regulatory Affairs
Education
The University of Texas at Austin 1981 — 1984
MS, Biochemistry
Loras College 1977 — 1981
BS, Chemistry and Biology
Horizon Pharma, Inc. June 2010 - Present
Clinsys Clinical Research April 2004 - May 2010
Paragon Biomedical October 1999 - January 2004
G. D. Searle September 1984 - October 1999
Skills
Clinical Development, Clinical Research, Clinical Trials, CRO, Clinical, IND, Pharmaceutical Industry, CTMS, ICH-GCP, Oncology, GCP, Therapeutic Areas, Clinical Monitoring, EDC, Biotechnology, FDA, Infectious Diseases, Regulatory Affairs
Education
The University of Texas at Austin 1981 — 1984
MS, Biochemistry
Loras College 1977 — 1981
BS, Chemistry and Biology
Donna Berk's Clinsys Clinical Research Experience July 2007 - August 2008
Job President at Emeritus Clinical Research Associates
Industry Pharmaceuticals
Experience
Emeritus Clinical Research Associates November 2012 - Present
HCRAmerica, US Office of Harrison Clinical Research March 2010 - October 2012
Quality Data Services April 2009 - November 2009
HCR America (Harrison Clinical Research) September 2008 - April 2009
Clinsys Clinical Research July 2007 - August 2008
Target Research Associates 1998 - 2005
Ohmeda June 1996 - June 1998
AztraZeneca 1994 - 1996
Besselaar 1994 - 1995
TheraKinetics 1990 - 1994
Skills
Clinical Research, CRO, Pharmaceuticals, Oncology, EDC, People Management, Project Management, Financial Management, Pharmaceutical Industry, Management, Managerial Finance, Biotechnology, Clinical Trials, Clinical Development, CTMS, Lifesciences, Clinical Monitoring, GCP, Pharmacovigilance, Therapeutic Areas, FDA
Education
Boston University 1987 — 1990
MS, Anatomy and Physiology
University of Pennsylvania 1983 — 1987
BA, Biological Basis of Behavior
Emeritus Clinical Research Associates November 2012 - Present
HCRAmerica, US Office of Harrison Clinical Research March 2010 - October 2012
Quality Data Services April 2009 - November 2009
HCR America (Harrison Clinical Research) September 2008 - April 2009
Clinsys Clinical Research July 2007 - August 2008
Target Research Associates 1998 - 2005
Ohmeda June 1996 - June 1998
AztraZeneca 1994 - 1996
Besselaar 1994 - 1995
TheraKinetics 1990 - 1994
Skills
Clinical Research, CRO, Pharmaceuticals, Oncology, EDC, People Management, Project Management, Financial Management, Pharmaceutical Industry, Management, Managerial Finance, Biotechnology, Clinical Trials, Clinical Development, CTMS, Lifesciences, Clinical Monitoring, GCP, Pharmacovigilance, Therapeutic Areas, FDA
Education
Boston University 1987 — 1990
MS, Anatomy and Physiology
University of Pennsylvania 1983 — 1987
BA, Biological Basis of Behavior
Cheri Gitter's Clinsys Clinical Research Experience April 2002 - November 2007
Job Clinical Research Specialist at SynteractHCR
Industry Pharmaceuticals
Experience
SynteractHCR April 2015 - Present
PRA Health Sciences March 2014 - April 2015
RPS - ReSearch Pharmaceutical Services Inc. 2007 - March 2014
Clinsys Clinical Research April 2002 - November 2007
Target Research Associates 2003 - 2007
Skills
CTMS, Clinical Trials, Regulatory Submissions, Oncology, Infectious Diseases, Clinical Monitoring, ICH-GCP, Clinical Operations, Clinical Research, CRO, GCP, EDC, Clinical Data Management, Clinical Development, Therapeutic Areas, Healthcare, CRF design, Oracle Clinical, Neurology, Pharmacovigilance, Drug Development, Sop, Endocrinology, Protocol, Pharmaceutical Industry, Clinical Research..., Phase I, Regulatory Affairs, Vaccines, SOP
Education
Milwaukee Area Technical College 1972 — 1974
A.A. S. Nursing, Registered Nurse Program
Washington High School 1967 — 1969
SynteractHCR April 2015 - Present
PRA Health Sciences March 2014 - April 2015
RPS - ReSearch Pharmaceutical Services Inc. 2007 - March 2014
Clinsys Clinical Research April 2002 - November 2007
Target Research Associates 2003 - 2007
Skills
CTMS, Clinical Trials, Regulatory Submissions, Oncology, Infectious Diseases, Clinical Monitoring, ICH-GCP, Clinical Operations, Clinical Research, CRO, GCP, EDC, Clinical Data Management, Clinical Development, Therapeutic Areas, Healthcare, CRF design, Oracle Clinical, Neurology, Pharmacovigilance, Drug Development, Sop, Endocrinology, Protocol, Pharmaceutical Industry, Clinical Research..., Phase I, Regulatory Affairs, Vaccines, SOP
Education
Milwaukee Area Technical College 1972 — 1974
A.A. S. Nursing, Registered Nurse Program
Washington High School 1967 — 1969
Roberta Steere's Clinsys Clinical Research Experience 2003 - 2006
Job Roberta Steere, Project Director, Covance, Inc.
Industry Pharmaceuticals
Experience
Covance, Inc. March 2013 - Present
Covance February 2012 - Present
PPD, Inc. May 2006 - February 2012
Clinsys Clinical Research 2003 - 2006
Bassett Healthcare 1993 - 1999
Skills
Oncology, Phase I, Medical Devices, Customer Relations, Financial Management, Clinical Research, Therapeutic areas, Clinical, Clinical Monitoring, Clinical Trial..., CRO, GCP, Clinical Trials, Infectious Diseases, CTMS, Diabetes, EDC, Endocrinology, Dermatology, Pharmaceuticals, Vaccines, Neurology, Clinical Development, SOP, Ophthalmology, Hematology, ICH-GCP, Cardiology, Gastroenterology, Clinical Pharmacology, Pain, Nephrology, Asthma, Line Management, Mentoring, Research, Drug Development, Therapeutic Areas, Protocol, Pain Management, Sop, Pharmaceutical Industry, Regulatory Submissions, Pharmacovigilance, Clinical Operations
Education
RSCS
SUNY Polytechnic Institute
Covance, Inc. March 2013 - Present
Covance February 2012 - Present
PPD, Inc. May 2006 - February 2012
Clinsys Clinical Research 2003 - 2006
Bassett Healthcare 1993 - 1999
Skills
Oncology, Phase I, Medical Devices, Customer Relations, Financial Management, Clinical Research, Therapeutic areas, Clinical, Clinical Monitoring, Clinical Trial..., CRO, GCP, Clinical Trials, Infectious Diseases, CTMS, Diabetes, EDC, Endocrinology, Dermatology, Pharmaceuticals, Vaccines, Neurology, Clinical Development, SOP, Ophthalmology, Hematology, ICH-GCP, Cardiology, Gastroenterology, Clinical Pharmacology, Pain, Nephrology, Asthma, Line Management, Mentoring, Research, Drug Development, Therapeutic Areas, Protocol, Pain Management, Sop, Pharmaceutical Industry, Regulatory Submissions, Pharmacovigilance, Clinical Operations
Education
RSCS
SUNY Polytechnic Institute
Galit Beresteanu (Waks)'s Clinsys Clinical Research Experience April 2011 - July 2011
Job Director, Project Delivery at PRA International
Industry Pharmaceuticals
Experience
PRA International November 2013 - Present
PRA International July 2011 - October 2013
Clinsys Clinical Research April 2011 - July 2011
Clinsys Clinical Research September 2009 - April 2011
PPD July 2004 - September 2009
PPD July 2001 - July 2004
kendle June 1999 - July 2001
Kendle International January 1998 - June 1999
Hebrew University 1992 - 1996
Hebrew University 1992 - 1996
Skills
CTMS, CRO, Clinical Development, Regulatory Affairs, Clinical Trials, Clinical Monitoring, Oncology, Pharmaceutical Industry, ICH-GCP, GCP, EDC, Clinical Data Management, Therapeutic Areas, Clinical Operations, Clinical Research, Infectious Diseases, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CRF design, Cardiology, Clinical Study Design, Data Management, Dermatology, Diabetes, Drug Development, Drug Discovery, Endocrinology, FDA, Hematology, IND, Immunology, Lifesciences, Medical Affairs, Medical Devices, Medical Writing, Patient Recruitment, Oracle Clinical, Pharmacology, Neurology, Pharmacovigilance, Phase I, Project Management, Protocol, Quality Assurance, Sop, Regulatory Submissions, Team Leadership, Trial Management, Vaccines
Education
Loyola University Chicago 1997 — 2000
MBA, Operations and International Business
The Hebrew University 1992 — 1996
B-Pharm, pharmacy
King David Linksfield 1987 — 1991
community day school
moshe sharet primary school
PRA International November 2013 - Present
PRA International July 2011 - October 2013
Clinsys Clinical Research April 2011 - July 2011
Clinsys Clinical Research September 2009 - April 2011
PPD July 2004 - September 2009
PPD July 2001 - July 2004
kendle June 1999 - July 2001
Kendle International January 1998 - June 1999
Hebrew University 1992 - 1996
Hebrew University 1992 - 1996
Skills
CTMS, CRO, Clinical Development, Regulatory Affairs, Clinical Trials, Clinical Monitoring, Oncology, Pharmaceutical Industry, ICH-GCP, GCP, EDC, Clinical Data Management, Therapeutic Areas, Clinical Operations, Clinical Research, Infectious Diseases, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CRF design, Cardiology, Clinical Study Design, Data Management, Dermatology, Diabetes, Drug Development, Drug Discovery, Endocrinology, FDA, Hematology, IND, Immunology, Lifesciences, Medical Affairs, Medical Devices, Medical Writing, Patient Recruitment, Oracle Clinical, Pharmacology, Neurology, Pharmacovigilance, Phase I, Project Management, Protocol, Quality Assurance, Sop, Regulatory Submissions, Team Leadership, Trial Management, Vaccines
Education
Loyola University Chicago 1997 — 2000
MBA, Operations and International Business
The Hebrew University 1992 — 1996
B-Pharm, pharmacy
King David Linksfield 1987 — 1991
community day school
moshe sharet primary school
Abhijit Debnath's Clinsys Clinical Research Experience 2006 - 2007
Job Senior Manager, Clinical Database Systems at Progenics Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Progenics Pharmaceuticals July 2007 - Present
Clinsys Clinical Research 2006 - 2007
Forest Laboratories 1999 - 2006
Skills
Clinical Research, Clinical Trials, Clinical Data Management, EDC, CRO
Education
Regis University 2008 — 2010
MBA, General
Progenics Pharmaceuticals July 2007 - Present
Clinsys Clinical Research 2006 - 2007
Forest Laboratories 1999 - 2006
Skills
Clinical Research, Clinical Trials, Clinical Data Management, EDC, CRO
Education
Regis University 2008 — 2010
MBA, General
John Hogan's Clinsys Clinical Research Experience March 2011 - October 2013
Job Director, Project Management at Harvard Clinical Research Institute
Industry Pharmaceuticals
Experience
Harvard Clinical Research Institute October 2013 - Present
Clinsys Clinical Research March 2011 - October 2013
Clinsys March 2008 - March 2011
Clinsys Clinical Research January 2007 - March 2008
Sepracor May 2003 - January 2007
Sepracor Pharma 2003 - 2007
INC Research 1999 - 2003
Cato Research 1996 - 1997
PAREXEL 1995 - 1997
PPD 1995 - 1996
Skills
CRO, Clinical Trials, CTMS, GCP, Clinical Development, EDC, Clinical Monitoring, Pharmaceutical Industry, Oncology, Clinical Research, Therapeutic Areas, Clinical Data Management, ICH-GCP, Biotechnology, Sop, FDA, Regulatory Affairs, Regulatory Submissions, Infectious Diseases, Drug Development, Lifesciences, Clinical Study Design, Medical Devices, CRF design, Pharmacovigilance, Protocol, Clinical Operations, IND, 21 CFR Part 11, Medical Writing, Neurology, Data Management, Vaccines, Medical Affairs, Patient Recruitment, Inform, Project Management, Management, Dermatology, Oracle Clinical, Biopharmaceuticals, Phase I, Trial Management, Endocrinology
Education
Western Carolina University 2003 — 2005
Masters of Project Management, Project Management
Rutgers University 1989 — 1993
Bachelor of Arts, Biology
Harvard Clinical Research Institute October 2013 - Present
Clinsys Clinical Research March 2011 - October 2013
Clinsys March 2008 - March 2011
Clinsys Clinical Research January 2007 - March 2008
Sepracor May 2003 - January 2007
Sepracor Pharma 2003 - 2007
INC Research 1999 - 2003
Cato Research 1996 - 1997
PAREXEL 1995 - 1997
PPD 1995 - 1996
Skills
CRO, Clinical Trials, CTMS, GCP, Clinical Development, EDC, Clinical Monitoring, Pharmaceutical Industry, Oncology, Clinical Research, Therapeutic Areas, Clinical Data Management, ICH-GCP, Biotechnology, Sop, FDA, Regulatory Affairs, Regulatory Submissions, Infectious Diseases, Drug Development, Lifesciences, Clinical Study Design, Medical Devices, CRF design, Pharmacovigilance, Protocol, Clinical Operations, IND, 21 CFR Part 11, Medical Writing, Neurology, Data Management, Vaccines, Medical Affairs, Patient Recruitment, Inform, Project Management, Management, Dermatology, Oracle Clinical, Biopharmaceuticals, Phase I, Trial Management, Endocrinology
Education
Western Carolina University 2003 — 2005
Masters of Project Management, Project Management
Rutgers University 1989 — 1993
Bachelor of Arts, Biology
Ajay Ohri's Clinsys Clinical Research Experience December 2006 - October 2008
Job Global Head of Business Development at Navin Fluorine International Ltd.
Industry Pharmaceuticals
Experience
Navin Fluorine International / Manchester Organics Limited September 2011 - Present
Idis Inc January 2010 - October 2011
Clinsys Clinical Research Inc. August 2008 - April 2009
Clinsys Clinical Research December 2006 - October 2008
AAI Pharma January 2001 - March 2004
Clinicor 1997 - 2000
Skills
Pharmaceutical Industry, CRO, Strategy, Business Development, Competitive Analysis, Management, Leadership, CRM, New Business Development, Product Development, Marketing Strategy, Product Launch, Strategic Planning, Negotiation, Selling, Team Building, Project Planning, Drug Development, Cross-functional Team..., Budgets, Market Research, Biotechnology, Pharmaceutics, Biopharmaceuticals, Manufacturing, Clinical Development, Technology Transfer, GMP, Clinical Trials, Oncology, Drug Discovery, R&D, Key Account Management, Strategic Partnerships, Commercialization, Medicinal Chemistry, Sop, Validation, GLP, Lifesciences, Medical Devices, CTMS, Therapeutic Areas, Pharmaceutical Sales, Infectious Diseases, Life Sciences
Education
Delhi University 1977 — 1981
BS, Chem
Air Force Central School 1972 — 1976
High Scool, Science
Navin Fluorine International / Manchester Organics Limited September 2011 - Present
Idis Inc January 2010 - October 2011
Clinsys Clinical Research Inc. August 2008 - April 2009
Clinsys Clinical Research December 2006 - October 2008
AAI Pharma January 2001 - March 2004
Clinicor 1997 - 2000
Skills
Pharmaceutical Industry, CRO, Strategy, Business Development, Competitive Analysis, Management, Leadership, CRM, New Business Development, Product Development, Marketing Strategy, Product Launch, Strategic Planning, Negotiation, Selling, Team Building, Project Planning, Drug Development, Cross-functional Team..., Budgets, Market Research, Biotechnology, Pharmaceutics, Biopharmaceuticals, Manufacturing, Clinical Development, Technology Transfer, GMP, Clinical Trials, Oncology, Drug Discovery, R&D, Key Account Management, Strategic Partnerships, Commercialization, Medicinal Chemistry, Sop, Validation, GLP, Lifesciences, Medical Devices, CTMS, Therapeutic Areas, Pharmaceutical Sales, Infectious Diseases, Life Sciences
Education
Delhi University 1977 — 1981
BS, Chem
Air Force Central School 1972 — 1976
High Scool, Science
Lynne Knauss's Clinsys Clinical Research Experience 2001 - 2007
Job Manager, Clinical Trials at Kyowa Hakko Kirin Pharma, Inc.
Industry Research
Experience
Kyowa Hakko Kirin Pharma, Inc. November 2013 - Present
Source Consulting, LLC 1998 - Present
Source Consulting, LLC 1998 - Present
Kyowa Hakko Kirin Pharma, Inc. March 2013 - November 2013
Cmed Clinical Services February 2012 - March 2013
Enzon Pharmaceuticals March 2010 - January 2012
BD Diagnostics, TriPath Imaging May 2007 - May 2009
Clinsys Clinical Research 2001 - 2007
Skills
Research, Teaching, Economics, Microsoft Office, Strategic Planning, Team Leadership, Mentoring, Clinical Trials, Clinical Monitoring, Oncology, Infectious Diseases, EDC, GCP, Clinical Data Management, Pharmaceutical Industry, Pharmacovigilance, Clinical Development, Quality Assurance, CRO, Clinical Research
Education
University of Delaware 1976 — 1980
B.A.A.S, Economics, 3.9/4.0
Burlington County College 1991 — 1995
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse, 3.8/4.0
Kyowa Hakko Kirin Pharma, Inc. November 2013 - Present
Source Consulting, LLC 1998 - Present
Source Consulting, LLC 1998 - Present
Kyowa Hakko Kirin Pharma, Inc. March 2013 - November 2013
Cmed Clinical Services February 2012 - March 2013
Enzon Pharmaceuticals March 2010 - January 2012
BD Diagnostics, TriPath Imaging May 2007 - May 2009
Clinsys Clinical Research 2001 - 2007
Skills
Research, Teaching, Economics, Microsoft Office, Strategic Planning, Team Leadership, Mentoring, Clinical Trials, Clinical Monitoring, Oncology, Infectious Diseases, EDC, GCP, Clinical Data Management, Pharmaceutical Industry, Pharmacovigilance, Clinical Development, Quality Assurance, CRO, Clinical Research
Education
University of Delaware 1976 — 1980
B.A.A.S, Economics, 3.9/4.0
Burlington County College 1991 — 1995
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse, 3.8/4.0
Helene Pearlman's Clinsys Clinical Research Experience August 2005 - January 2008
Job Manager, Clinical Operations, Global Clinical Pharmacology at Astellas Pharma
Industry Pharmaceuticals
Experience
Astellas Pharma September 2008 - Present
Clinsys Clinical Research August 2005 - January 2008
PAREXEL 1997 - 2005
Lorex Pharmaceuticals, Inc. 1995 - 1997
Abbott Laboratories 1982 - 1995
Skills
Clinical Pharmacology, CTMS, CRO, Clinical Development, GCP, Clinical Operations, Clinical Trials, Clinical Monitoring, Medical Writing, Clinical Research, Protocol, Therapeutic Areas, ICH-GCP, Drug Development, Oncology, Clinical Data Management, Pharmaceutical Industry, EDC, Infectious Diseases, Regulatory Affairs, Sop, Biotechnology, FDA
Education
Northeastern Illinois University 1978 — 1981
M.S., Biology
George Williams College 1971 — 1976
B.S., Biology
Astellas Pharma September 2008 - Present
Clinsys Clinical Research August 2005 - January 2008
PAREXEL 1997 - 2005
Lorex Pharmaceuticals, Inc. 1995 - 1997
Abbott Laboratories 1982 - 1995
Skills
Clinical Pharmacology, CTMS, CRO, Clinical Development, GCP, Clinical Operations, Clinical Trials, Clinical Monitoring, Medical Writing, Clinical Research, Protocol, Therapeutic Areas, ICH-GCP, Drug Development, Oncology, Clinical Data Management, Pharmaceutical Industry, EDC, Infectious Diseases, Regulatory Affairs, Sop, Biotechnology, FDA
Education
Northeastern Illinois University 1978 — 1981
M.S., Biology
George Williams College 1971 — 1976
B.S., Biology
Aimee Harel's Clinsys Clinical Research Experience September 2004 - July 2008
Job Associate Director, Clin Ops at Eisai Pharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Pharmaceuticals August 2008 - Present
Clinsys Clinical Research September 2004 - July 2008
Ingenix Pharmaceutical Svc 2000 - 2002
Education
State University of New York College at Buffalo 1977 — 1981
BA, Biology
State University of New York at Buffalo 1977 — 1981
Eisai Pharmaceuticals August 2008 - Present
Clinsys Clinical Research September 2004 - July 2008
Ingenix Pharmaceutical Svc 2000 - 2002
Education
State University of New York College at Buffalo 1977 — 1981
BA, Biology
State University of New York at Buffalo 1977 — 1981
Cindy MacKay's Clinsys Clinical Research Experience Project ManagementClinsys2000 - Present
Job Project Manager at Clinsys Clinical Research
Industry Pharmaceuticals
Experience
Clinsys Clinical Research Project ManagementClinsys2000 - Present
Skills
CTMS, Infectious Diseases, CRO, ICH-GCP, EDC, Clinical Trials, GCP, Oncology, Pharmaceutical Industry, Clinical Research, Project Management, Pharmacovigilance, Clinical Development, Therapeutic Areas, Sop, Clinical Data Management, Regulatory Affairs, Clinical Monitoring, Regulatory Submissions, CRF design
Education
University of Delaware 1984 — 1988
Clinsys Clinical Research Project ManagementClinsys2000 - Present
Skills
CTMS, Infectious Diseases, CRO, ICH-GCP, EDC, Clinical Trials, GCP, Oncology, Pharmaceutical Industry, Clinical Research, Project Management, Pharmacovigilance, Clinical Development, Therapeutic Areas, Sop, Clinical Data Management, Regulatory Affairs, Clinical Monitoring, Regulatory Submissions, CRF design
Education
University of Delaware 1984 — 1988
Allen Mosley's Clinsys Clinical Research Experience June 2005 - February 2007
Job Sr. CRA at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL May 2015 - Present
inVentiv Health Clinical November 2014 - April 2015
ICON plc September 2013 - November 2014
Quintiles November 2010 - September 2013
ReSearch Pharmaceutical Services February 2009 - November 2010
ReSearch Pharmaceutical Services February 2007 - February 2009
Clinsys Clinical Research June 2005 - February 2007
Clinsys Clinical Research January 2004 - May 2005
Clinsys Clinical Research July 2001 - January 2004
UAB Hospital April 2000 - July 2001
Skills
ICH-GCP, Clinical Research, GCP, CTMS, Clinical Monitoring, Pharmaceutical Industry, CRO, Clinical Trials, Clinical Research..., Neurology, EDC, Regulatory Submissions, Diabetes, Sop, Cardiology, Pharmacovigilance, Clinical Operations, Clinical Development, Endocrinology, Drug Development, Dermatology, Therapeutic Areas, FDA, Oncology, Clinical Data Management, Medical Writing, Regulatory Affairs, Hematology, Patient Recruitment, Biotechnology, Infectious Diseases, Healthcare, Protocol
Education
Loyola University New Orleans 2012 — 2016
Master’s Degree, Nursing Health Care Systems Management
University of Alabama at Birmingham 1992 — 1996
Bachelor of Science Nursing, Nursing
University of Alabama 1985 — 1988
Bachelor of Science Commerce and Business Administration, Corporate Finance and Investment Management
PAREXEL May 2015 - Present
inVentiv Health Clinical November 2014 - April 2015
ICON plc September 2013 - November 2014
Quintiles November 2010 - September 2013
ReSearch Pharmaceutical Services February 2009 - November 2010
ReSearch Pharmaceutical Services February 2007 - February 2009
Clinsys Clinical Research June 2005 - February 2007
Clinsys Clinical Research January 2004 - May 2005
Clinsys Clinical Research July 2001 - January 2004
UAB Hospital April 2000 - July 2001
Skills
ICH-GCP, Clinical Research, GCP, CTMS, Clinical Monitoring, Pharmaceutical Industry, CRO, Clinical Trials, Clinical Research..., Neurology, EDC, Regulatory Submissions, Diabetes, Sop, Cardiology, Pharmacovigilance, Clinical Operations, Clinical Development, Endocrinology, Drug Development, Dermatology, Therapeutic Areas, FDA, Oncology, Clinical Data Management, Medical Writing, Regulatory Affairs, Hematology, Patient Recruitment, Biotechnology, Infectious Diseases, Healthcare, Protocol
Education
Loyola University New Orleans 2012 — 2016
Master’s Degree, Nursing Health Care Systems Management
University of Alabama at Birmingham 1992 — 1996
Bachelor of Science Nursing, Nursing
University of Alabama 1985 — 1988
Bachelor of Science Commerce and Business Administration, Corporate Finance and Investment Management
Gina Hodges's Clinsys Clinical Research Experience January 2007 - June 2010
Job Senior Business Development Associate at Duke Clinical Research Institute
Industry Research
Experience
Duke Clinical Research Institute January 2012 - Present
PharmaNet\i3 (formerly inVentiv Clinical Solutions, LLC) 2010 - 2011
PharmaNet Development Group, Inc June 2010 - October 2010
Clinsys Clinical Research January 2007 - June 2010
INC Research 2002 - 2006
Quintiles, Inc July 2000 - May 2002
Education
North Carolina Wesleyan College 1997 — 1999
Bachelor's Degree, Accounting and Business Administration
Pitt Community College 1995 — 1997
Associates Degree, Marketing and Retailing
Duke Clinical Research Institute January 2012 - Present
PharmaNet\i3 (formerly inVentiv Clinical Solutions, LLC) 2010 - 2011
PharmaNet Development Group, Inc June 2010 - October 2010
Clinsys Clinical Research January 2007 - June 2010
INC Research 2002 - 2006
Quintiles, Inc July 2000 - May 2002
Education
North Carolina Wesleyan College 1997 — 1999
Bachelor's Degree, Accounting and Business Administration
Pitt Community College 1995 — 1997
Associates Degree, Marketing and Retailing
Murilo Brizzotti's Clinsys Clinical Research Experience February 2009 - July 2010
Job Risk Intelligence Consultant Principal Analytical Consultant at SAS
Industry Computer Software
Experience
SAS August 2010 - Present
Clinsys Clinical Research February 2009 - July 2010
SAS July 2004 - July 2008
SSA Global May 2002 - June 2004
Computer Associates January 2001 - May 2002
Skills
R, OLAP, Java, C++, Segmentation, Credit Scoring, Delphi, SAS, Data Mining, Predictive Analytics, Business Analytics, Data Integration, SAS programming, Business Intelligence, Data Modeling, CRM, Strategy, Statistical Modeling, Analytics, ETL, Enterprise Software, Pre-sales, Oracle, Data Warehousing, Data Analysis, Statistics, Quantitative Analytics, Cognos, Analysis, Time Series Analysis, Data Quality, Predictive Modeling, Optimization, Customer Analysis, Decision Trees, Big Data, Data Warehouse..., Data Management, Dashboard, VBA, Hadoop, Text Mining, Market Risk, SQL
Education
North Carolina State University 2008 — 2010
Master, Statistics
Universidade de São Paulo 1996 — 2000
Bachelor, Computer Science
SAS August 2010 - Present
Clinsys Clinical Research February 2009 - July 2010
SAS July 2004 - July 2008
SSA Global May 2002 - June 2004
Computer Associates January 2001 - May 2002
Skills
R, OLAP, Java, C++, Segmentation, Credit Scoring, Delphi, SAS, Data Mining, Predictive Analytics, Business Analytics, Data Integration, SAS programming, Business Intelligence, Data Modeling, CRM, Strategy, Statistical Modeling, Analytics, ETL, Enterprise Software, Pre-sales, Oracle, Data Warehousing, Data Analysis, Statistics, Quantitative Analytics, Cognos, Analysis, Time Series Analysis, Data Quality, Predictive Modeling, Optimization, Customer Analysis, Decision Trees, Big Data, Data Warehouse..., Data Management, Dashboard, VBA, Hadoop, Text Mining, Market Risk, SQL
Education
North Carolina State University 2008 — 2010
Master, Statistics
Universidade de São Paulo 1996 — 2000
Bachelor, Computer Science
Michael Remavich's Clinsys Clinical Research Experience April 2009 - February 2010
Job Director Data Management at Shire
Industry Pharmaceuticals
Experience
Shire Senior Director, Data ManagementAptiv SolutionsJune 2013 - June 2015
Celgene June 2010 - December 2011
Clinsys Clinical Research April 2009 - February 2010
PPD September 1997 - February 2008
Novartis 1987 - 1997
Skills
Data Management, Clinical Research, Clinical, Biostatistics, Statistics, EDC, CDM, SAS, Process Improvement, Performance Metrics, Cross-functional Team..., Outsourcing, Pharmaceutical Industry, Clinical Trials, Project Management, GCP, CRO, CTMS, Clinical Development, FDA, Clinical Data Management, 21 CFR Part 11, Therapeutic Areas, Oncology
Education
University of Rochester 1981 — 1987
Master's, Medical Statistics
Shire Senior Director, Data ManagementAptiv SolutionsJune 2013 - June 2015
Celgene June 2010 - December 2011
Clinsys Clinical Research April 2009 - February 2010
PPD September 1997 - February 2008
Novartis 1987 - 1997
Skills
Data Management, Clinical Research, Clinical, Biostatistics, Statistics, EDC, CDM, SAS, Process Improvement, Performance Metrics, Cross-functional Team..., Outsourcing, Pharmaceutical Industry, Clinical Trials, Project Management, GCP, CRO, CTMS, Clinical Development, FDA, Clinical Data Management, 21 CFR Part 11, Therapeutic Areas, Oncology
Education
University of Rochester 1981 — 1987
Master's, Medical Statistics
Jennifer Auerbach's Clinsys Clinical Research Experience 2005 - 2006
Job Sr. Project Manager at Premier Research
Industry Pharmaceuticals
Experience
Premier Research November 2013 - Present
TKL Research April 2013 - November 2013
Pfizer (ExecuPharm Contractor) January 2011 - April 2013
Salix Pharmaceuticals April 2010 - January 2011
Novella Clinical 2007 - April 2010
INC Research May 2006 - August 2007
Clinsys Clinical Research 2005 - 2006
Clinsys Clinical Research 2004 - 2005
Clinsys Clinical research 2001 - 2004
Seattle Children's 1999 - 2001
Skills
CTMS, CRO, EDC, Clinical Trials, GCP, FDA, Budgets, Timelines, Therapeutic area..., Clinical Research, Phase I, Phase 2, Pharmacueticals, PK/PD, Vendor Management, CRAs, Medical Devices, Therapeutic Areas, Clinical Monitoring, Clinical Development, Clinical Operations, ICH-GCP, Ophthalmology, Clinical Data Management
Education
Penn State University 1996 — 1998
MS, Pathobiology
Penn State University 1992 — 1996
BS, Animal Bioscience
Premier Research November 2013 - Present
TKL Research April 2013 - November 2013
Pfizer (ExecuPharm Contractor) January 2011 - April 2013
Salix Pharmaceuticals April 2010 - January 2011
Novella Clinical 2007 - April 2010
INC Research May 2006 - August 2007
Clinsys Clinical Research 2005 - 2006
Clinsys Clinical Research 2004 - 2005
Clinsys Clinical research 2001 - 2004
Seattle Children's 1999 - 2001
Skills
CTMS, CRO, EDC, Clinical Trials, GCP, FDA, Budgets, Timelines, Therapeutic area..., Clinical Research, Phase I, Phase 2, Pharmacueticals, PK/PD, Vendor Management, CRAs, Medical Devices, Therapeutic Areas, Clinical Monitoring, Clinical Development, Clinical Operations, ICH-GCP, Ophthalmology, Clinical Data Management
Education
Penn State University 1996 — 1998
MS, Pathobiology
Penn State University 1992 — 1996
BS, Animal Bioscience
Prakash Didugu's Clinsys Clinical Research Experience October 2008 - January 2009
Job Sr. Statistical Programmer at Abbvie
Industry Pharmaceuticals
Experience
Abbvie January 2015 - Present
Veristat, Inc. February 2009 - Present
Eliassen Group - Pfizer May 2010 - August 2011
i3 Statprobe February 2008 - August 2009
Clinsys Clinical Research October 2008 - January 2009
Skills
CDISC, Clinical Trials, Pharmaceutical Industry, SAS Programming, SAS, Oncology, Clinical Data Management, CRO, Statistical Programming, FDA, SDTM
Education
Bowling Green State University 1992 — 1996
Abbvie January 2015 - Present
Veristat, Inc. February 2009 - Present
Eliassen Group - Pfizer May 2010 - August 2011
i3 Statprobe February 2008 - August 2009
Clinsys Clinical Research October 2008 - January 2009
Skills
CDISC, Clinical Trials, Pharmaceutical Industry, SAS Programming, SAS, Oncology, Clinical Data Management, CRO, Statistical Programming, FDA, SDTM
Education
Bowling Green State University 1992 — 1996
James Pombrio's Clinsys Clinical Research Experience 2001 - 2005
Job Statistical (SAS) Programmer at ReSearch Pharmaceutical Services
Industry Pharmaceuticals
Experience
Research Pharmaceutical Services September 2011 - Present
Genentech (formerly Hoffmann-La Roche) September 2010 - September 2011
Genentech (Formerly Hoffmann-La Roche) February 2008 - September 2010
Cmed January 2006 - 2008
Cmed May 2005 - December 2005
Clinsys Clinical Research 2001 - 2005
Biomatrix 2000 - 2001
Pfizer 1998 - 1998
Skills
Clinical Data Management, CDISC, Clinical Trials, CRO, Biostatistics, GCP, EDC, SAS programming, Clinical Development, SAS, Medidata, Data Management
Education
PharmaSchool 2012 — 2012
Statistics for Non Statisticians short course, Statistics, N/A
SAS Institute 2011 — 2011
SAS Programming I & II courses, SAS
University of Rochester School of Medicine and Dentistry 1998 — 1999
State University of New York College at Plattsburgh 1991 — 1997
B.A., Mathematics and Biology, Chemistry minor
Research Pharmaceutical Services September 2011 - Present
Genentech (formerly Hoffmann-La Roche) September 2010 - September 2011
Genentech (Formerly Hoffmann-La Roche) February 2008 - September 2010
Cmed January 2006 - 2008
Cmed May 2005 - December 2005
Clinsys Clinical Research 2001 - 2005
Biomatrix 2000 - 2001
Pfizer 1998 - 1998
Skills
Clinical Data Management, CDISC, Clinical Trials, CRO, Biostatistics, GCP, EDC, SAS programming, Clinical Development, SAS, Medidata, Data Management
Education
PharmaSchool 2012 — 2012
Statistics for Non Statisticians short course, Statistics, N/A
SAS Institute 2011 — 2011
SAS Programming I & II courses, SAS
University of Rochester School of Medicine and Dentistry 1998 — 1999
State University of New York College at Plattsburgh 1991 — 1997
B.A., Mathematics and Biology, Chemistry minor
Shalvi Patel's Clinsys Clinical Research Experience August 2009 - August 2010
Job Senior Clinical Manager at Novartis Pharmaceuticals
Industry Research
Experience
Novartis Pharmaceuticals June 2014 - Present
Forest Research Insitute August 2010 - May 2014
Clinsys Clinical Research August 2009 - August 2010
RadPharm May 2008 - August 2009
Johnson & Johnson May 2007 - April 2008
Ethicon: Johnson & Johnson May 2006 - September 2006
Skills
cGMP, GMP, Medical Devices, Clinical Trials, Clinical Research, Regulatory Affairs
Education
Temple University, School of Pharmacy 2009 — 2011
Master's degree, QA/Regulatory Affairs
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2007
Bachelor of Arts (B.A.), Biological Sciences
Novartis Pharmaceuticals June 2014 - Present
Forest Research Insitute August 2010 - May 2014
Clinsys Clinical Research August 2009 - August 2010
RadPharm May 2008 - August 2009
Johnson & Johnson May 2007 - April 2008
Ethicon: Johnson & Johnson May 2006 - September 2006
Skills
cGMP, GMP, Medical Devices, Clinical Trials, Clinical Research, Regulatory Affairs
Education
Temple University, School of Pharmacy 2009 — 2011
Master's degree, QA/Regulatory Affairs
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2007
Bachelor of Arts (B.A.), Biological Sciences
Gregg Kebler's Clinsys Clinical Research Experience June 2006 - February 2010
Job Senior Lead Clinical Data Manager at Johnson & Johnson
Industry Pharmaceuticals
Experience
Clinsys Clinical Research June 2006 - February 2010
Johnson & Johnson June 2009 - June 2009
Home Office/Business 2005 - 2006
Sanofi-Aventis March 2004 - April 2005
The Upjohn Co / Pharmacia / Pfizer 1982 - 2003
Skills
Clinical Trial..., Clinical, Clinical Research, Data Management, Oracle Clinical, CRF design, GCP, Pharmaceuticals, CRO, Clinical Development, Clinical Data Management, EDC, Oncology, 21 CFR Part 11, Infectious Diseases, ICH-GCP, SOP, Data Analysis, Database Administration, CTMS, Validation, Pharmaceutical Industry, SAS, Clinical Trials, Sop
Education
Western Michigan University - Haworth College of Business 1983 — 1986
BA, Business Management
Michigan State University College of Human Medicine 1979 — 1981
BS, Medical Technology
Clinsys Clinical Research June 2006 - February 2010
Johnson & Johnson June 2009 - June 2009
Home Office/Business 2005 - 2006
Sanofi-Aventis March 2004 - April 2005
The Upjohn Co / Pharmacia / Pfizer 1982 - 2003
Skills
Clinical Trial..., Clinical, Clinical Research, Data Management, Oracle Clinical, CRF design, GCP, Pharmaceuticals, CRO, Clinical Development, Clinical Data Management, EDC, Oncology, 21 CFR Part 11, Infectious Diseases, ICH-GCP, SOP, Data Analysis, Database Administration, CTMS, Validation, Pharmaceutical Industry, SAS, Clinical Trials, Sop
Education
Western Michigan University - Haworth College of Business 1983 — 1986
BA, Business Management
Michigan State University College of Human Medicine 1979 — 1981
BS, Medical Technology
Jeremy Helgevold's Clinsys Clinical Research Experience May 2008 - January 2010
Job Lead Configuration Analyst at Bracket
Industry Pharmaceuticals
Experience
Bracket January 2012 - Present
United BioSource Corporation August 2010 - January 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2010 - August 2010
Clinsys Clinical Research May 2008 - January 2010
INC Research May 2004 - April 2008
INC Research June 2003 - April 2004
Skills
Oracle Clinical, Clinical Trials, Clinical Research, EDC, Medidata, SAS, Clinical Data Management, Microsoft Office, CRO, Data Management, CDISC
Education
North Carolina State University 1999 — 2013
Bachelor's degree, Computer Science
North Carolina State University 1999 — 2003
Bachelor of Science (BS), Computer Science
Bracket January 2012 - Present
United BioSource Corporation August 2010 - January 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2010 - August 2010
Clinsys Clinical Research May 2008 - January 2010
INC Research May 2004 - April 2008
INC Research June 2003 - April 2004
Skills
Oracle Clinical, Clinical Trials, Clinical Research, EDC, Medidata, SAS, Clinical Data Management, Microsoft Office, CRO, Data Management, CDISC
Education
North Carolina State University 1999 — 2013
Bachelor's degree, Computer Science
North Carolina State University 1999 — 2003
Bachelor of Science (BS), Computer Science
Phyllis Stein Beal's Clinsys Clinical Research Experience July 2010 - Present
Job Clinical Teram Leader at Clinsys Clinical Research
Industry Research
Experience
Clinsys Clinical Research July 2010 - Present
Clinsys Clinical Research February 2005 - July 2010
Grand Rapids Clinical Oncology Program September 1986 - February 2005
Education
Grand Valley State University 1994 — 2000
Clinsys Clinical Research July 2010 - Present
Clinsys Clinical Research February 2005 - July 2010
Grand Rapids Clinical Oncology Program September 1986 - February 2005
Education
Grand Valley State University 1994 — 2000
Lisa Whitehead's Clinsys Clinical Research Experience August 2008 - Present
Job Project Manager
Industry Pharmaceuticals
Experience
Clinsys Clinical Research August 2008 - Present
ExecuPharm / Pfizer May 2008 - August 2008
Wyeth 2005 - 2008
GlaxoSmithKline 1999 - 2005
GlaxoSmithKline 1999 - 2005
Education
St. Luke's Hospital School of Nursing 1977 — 1979
RN, Nursing
Kutztown University of Pennsylvania
Clinsys Clinical Research August 2008 - Present
ExecuPharm / Pfizer May 2008 - August 2008
Wyeth 2005 - 2008
GlaxoSmithKline 1999 - 2005
GlaxoSmithKline 1999 - 2005
Education
St. Luke's Hospital School of Nursing 1977 — 1979
RN, Nursing
Kutztown University of Pennsylvania
Cheryl New's Clinsys Clinical Research Experience September 2007 - September 2008
Job Senior Director, Quality Assurance GCP at Insmed, Inc.
Industry Pharmaceuticals
Experience
Insmed, Inc. January 2014 - Present
Canfield Scientific, Inc. March 2012 - November 2013
Quality Catalyst Partners September 2008 - January 2013
PharmaBoard Partners, LLC. June 2009 - April 2012
Clinsys Clinical Research September 2007 - September 2008
Aventis September 2000 - February 2005
Emerald Solutions 1999 - 2000
Axis Systems/Platinum Technology 1994 - 1999
Skills
21 CFR Part 11, Clinical Research, Clinical Trials, Process Improvement, GCP, Lifesciences, Biotechnology, CRO, Cross-functional Team..., Pharmaceutical Industry, Biopharmaceuticals, Management, Regulatory Affairs, Therapeutic Areas, Product Development, Strategy, Medical Affairs, Sop, Clinical Operations, Pharmaceutics, Software Documentation, ICH-GCP, Regulatory Submissions, Clinical Development, Quality Assurance, CTMS, FDA
Education
Antioch New England Graduate School, Antioch University 1977 — 1979
Master's degree
City University of New York-Hunter College 1972 — 1974
B.A. Cum Laude, Psychology, Education, Dance Therapy
Insmed, Inc. January 2014 - Present
Canfield Scientific, Inc. March 2012 - November 2013
Quality Catalyst Partners September 2008 - January 2013
PharmaBoard Partners, LLC. June 2009 - April 2012
Clinsys Clinical Research September 2007 - September 2008
Aventis September 2000 - February 2005
Emerald Solutions 1999 - 2000
Axis Systems/Platinum Technology 1994 - 1999
Skills
21 CFR Part 11, Clinical Research, Clinical Trials, Process Improvement, GCP, Lifesciences, Biotechnology, CRO, Cross-functional Team..., Pharmaceutical Industry, Biopharmaceuticals, Management, Regulatory Affairs, Therapeutic Areas, Product Development, Strategy, Medical Affairs, Sop, Clinical Operations, Pharmaceutics, Software Documentation, ICH-GCP, Regulatory Submissions, Clinical Development, Quality Assurance, CTMS, FDA
Education
Antioch New England Graduate School, Antioch University 1977 — 1979
Master's degree
City University of New York-Hunter College 1972 — 1974
B.A. Cum Laude, Psychology, Education, Dance Therapy
Geetika Malik's Clinsys Clinical Research Experience August 2006 - Present
Job Asst. Finance Manager at Clinsys Clinical Research
Industry Pharmaceuticals
Experience
Clinsys Clinical Research August 2006 - Present
Skills
Financial Reporting, Managerial Finance, MIS
Education
Institute of Chartered Accountants of India 2005 — 2006
CA, Commerce
Kurukshetra University
Masters, Commerce
Clinsys Clinical Research August 2006 - Present
Skills
Financial Reporting, Managerial Finance, MIS
Education
Institute of Chartered Accountants of India 2005 — 2006
CA, Commerce
Kurukshetra University
Masters, Commerce
Linda Tensen Grimm's Clinsys Clinical Research Experience October 2006 - October 2006
Job Sr. Clinical Research Scientist at Novartis Pharmaceuticals Corp
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals Corp November 2012 - Present
ImClone Systems January 2009 - January 2012
Celgene May 2007 - May 2008
Clinsys Clinical Research October 2006 - October 2006
Research Assist, Inc. March 2006 - October 2006
Schering-Plough Research Institute March 1996 - July 1998
Schering-Plough Research Institute November 1992 - March 1996
Schering-Plough Research Institute January 1987 - January 1992
Schering-Plough Research Institute January 1984 - January 1987
Hospice of San Francisco January 1982 - January 1984
Skills
Clinical Trial..., Oncology, GCP, Clinical Trials, Clinical Development, Clinical Research, EDC, Clinical Monitoring, Hematology
Education
Niagara University
BSN
Novartis Pharmaceuticals Corp November 2012 - Present
ImClone Systems January 2009 - January 2012
Celgene May 2007 - May 2008
Clinsys Clinical Research October 2006 - October 2006
Research Assist, Inc. March 2006 - October 2006
Schering-Plough Research Institute March 1996 - July 1998
Schering-Plough Research Institute November 1992 - March 1996
Schering-Plough Research Institute January 1987 - January 1992
Schering-Plough Research Institute January 1984 - January 1987
Hospice of San Francisco January 1982 - January 1984
Skills
Clinical Trial..., Oncology, GCP, Clinical Trials, Clinical Development, Clinical Research, EDC, Clinical Monitoring, Hematology
Education
Niagara University
BSN
Jamie Gault's Clinsys Clinical Research Experience March 2008 - June 2010
Job Vice President, Regulatory Affairs and Quality at Scioderm, Inc.
Industry Pharmaceuticals
Experience
Scioderm, Inc. February 2015 - Present
Novella Clinical, Inc. June 2012 - February 2015
Aptiv Solutions (formerly Fulcrum Pharma Developments) June 2010 - June 2012
Clinsys Clinical Research March 2008 - June 2010
Campbell Univeristy 2004 - 2010
BioCryst Pharmaceuticals November 2006 - March 2008
Voyager Pharmaceutical Corp. 2004 - 2006
Duke Clinical Research Institute July 1999 - November 2004
Glaxo Inc 1989 - 1992
Skills
FDA, eCTD, Sop, Regulatory Requirements, Clinical Research, Biopharmaceuticals, Therapeutic Areas, GCPs, GMP, Biotechnology, Pharmacovigilance, CTMS, Clinical Development, Medical Devices, Dermatology, GLP, Medical Writing, Quality Assurance, ICH-GCP, 21 CFR Part 11, Regulations, Protocol, SOP
Education
Fairmont State University 1982 — 1986
BS, Chemistry
Scioderm, Inc. February 2015 - Present
Novella Clinical, Inc. June 2012 - February 2015
Aptiv Solutions (formerly Fulcrum Pharma Developments) June 2010 - June 2012
Clinsys Clinical Research March 2008 - June 2010
Campbell Univeristy 2004 - 2010
BioCryst Pharmaceuticals November 2006 - March 2008
Voyager Pharmaceutical Corp. 2004 - 2006
Duke Clinical Research Institute July 1999 - November 2004
Glaxo Inc 1989 - 1992
Skills
FDA, eCTD, Sop, Regulatory Requirements, Clinical Research, Biopharmaceuticals, Therapeutic Areas, GCPs, GMP, Biotechnology, Pharmacovigilance, CTMS, Clinical Development, Medical Devices, Dermatology, GLP, Medical Writing, Quality Assurance, ICH-GCP, 21 CFR Part 11, Regulations, Protocol, SOP
Education
Fairmont State University 1982 — 1986
BS, Chemistry
Nelly Freed's Clinsys Clinical Research Experience 2003 - 2006
Job Director, Vaccine and Oncology Center of Excellence at ICON plc
Industry Pharmaceuticals
Experience
ICON plc October 2011 - Present
ICON plc August 2011 - Present
i3 Research, Inc 2007 - September 2011
Clinsys 2003 - 2006
Clinsys Clinical Research 2003 - 2006
Target Research Associates 2001 - 2003
Target Research Associates 1998 - 2001
AstraZeneca 1994 - 1998
Skills
Vaccines, GCP, Clinical Trials, CRO, Clinical Development, Oncology, CTMS, Infectious Diseases, Clinical Operations, Clinical Data Management, Therapeutic Areas, EDC, Sop, Regulatory Affairs, ICH-GCP, Clinical Monitoring, Pharmaceutical Industry, Drug Development, Clinical Research
Education
Heidelberg University 1973 — 1974
Chemistry
Drexel University 1968 — 1973
BS, Chemistry
ICON plc October 2011 - Present
ICON plc August 2011 - Present
i3 Research, Inc 2007 - September 2011
Clinsys 2003 - 2006
Clinsys Clinical Research 2003 - 2006
Target Research Associates 2001 - 2003
Target Research Associates 1998 - 2001
AstraZeneca 1994 - 1998
Skills
Vaccines, GCP, Clinical Trials, CRO, Clinical Development, Oncology, CTMS, Infectious Diseases, Clinical Operations, Clinical Data Management, Therapeutic Areas, EDC, Sop, Regulatory Affairs, ICH-GCP, Clinical Monitoring, Pharmaceutical Industry, Drug Development, Clinical Research
Education
Heidelberg University 1973 — 1974
Chemistry
Drexel University 1968 — 1973
BS, Chemistry
James Pombrio's Clinsys Clinical Research Experience 2001 - 2005
Job Screenwriter
Industry Writing and Editing
Experience
Screenwriter January 2006 - Present
Hoffmann-La Roche 2010 - 2011
Cmed 2005 - 2008
Clinsys Clinical Research 2001 - 2005
Education
State University of New York College at Plattsburgh 1991 — 1997
B.A., Mathematics and Biology
State University of New York College at Plattsburgh
Screenwriter January 2006 - Present
Hoffmann-La Roche 2010 - 2011
Cmed 2005 - 2008
Clinsys Clinical Research 2001 - 2005
Education
State University of New York College at Plattsburgh 1991 — 1997
B.A., Mathematics and Biology
State University of New York College at Plattsburgh
Paulette Vines Williams's Clinsys Clinical Research Experience June 2007 - March 2010
Job Principal Biostatistician at UCB Biosciences
Industry Pharmaceuticals
Experience
UCB BioSciences June 2010 - Present
Clinsys Clinical Research June 2007 - March 2010
XTL Biopharmaceuticals, Ltd April 2004 - June 2007
Skills
Clinical Trials, Biostatistics, Statistical Programming, Clinical Study Design, Statistics, SAS programming, Clinical Development, CDISC, CRO, Pharmaceutical Industry, Clinical Data Management, SAS, Clinical Research, FDA, Lifesciences, CTMS, ICH-GCP, GCP, Drug Development, EDC, Regulatory Submissions, Protocol, SDTM, Oracle Clinical, Oncology, Therapeutic Areas, Data Management, Infectious Diseases, Survival Analysis
Education
North Carolina State University 1992 — 1995
MS
Rice University 1988 — 1992
BA
UCB BioSciences June 2010 - Present
Clinsys Clinical Research June 2007 - March 2010
XTL Biopharmaceuticals, Ltd April 2004 - June 2007
Skills
Clinical Trials, Biostatistics, Statistical Programming, Clinical Study Design, Statistics, SAS programming, Clinical Development, CDISC, CRO, Pharmaceutical Industry, Clinical Data Management, SAS, Clinical Research, FDA, Lifesciences, CTMS, ICH-GCP, GCP, Drug Development, EDC, Regulatory Submissions, Protocol, SDTM, Oracle Clinical, Oncology, Therapeutic Areas, Data Management, Infectious Diseases, Survival Analysis
Education
North Carolina State University 1992 — 1995
MS
Rice University 1988 — 1992
BA
Ronna Freeman's Clinsys Clinical Research Experience June 2010 - May 2011
Job Clinical Trial Specialist II at United Therapeutics
Industry Pharmaceuticals
Experience
United Therapeutics April 2015 - Present
United Therapeutics March 2011 - April 2015
Clinsys Clinical Research June 2010 - May 2011
Clinsys Clinical Research January 2008 - July 2010
GlaxoSmithKline March 2006 - January 2008
INC Research December 2005 - March 2006
INC Research June 2004 - December 2005
INC Research July 2003 - June 2004
INC Research July 2001 - July 2003
Duke University Health System April 1998 - July 2001
Skills
CRO, Clinical Monitoring, GCP, Clinical Trials, CTMS, Clinical Research, Sop, Protocol, EDC, Clinical Study Design, FDA, Clinical Development, Therapeutic Areas, ICH-GCP, Clinical Data Management, Regulatory Requirements, Oncology, Clinical Operations, SOP
Education
Western Carolina University 2002 — 2005
MPM, Project Management
Duke University 1993 — 1997
B.S., Biology
United Therapeutics April 2015 - Present
United Therapeutics March 2011 - April 2015
Clinsys Clinical Research June 2010 - May 2011
Clinsys Clinical Research January 2008 - July 2010
GlaxoSmithKline March 2006 - January 2008
INC Research December 2005 - March 2006
INC Research June 2004 - December 2005
INC Research July 2003 - June 2004
INC Research July 2001 - July 2003
Duke University Health System April 1998 - July 2001
Skills
CRO, Clinical Monitoring, GCP, Clinical Trials, CTMS, Clinical Research, Sop, Protocol, EDC, Clinical Study Design, FDA, Clinical Development, Therapeutic Areas, ICH-GCP, Clinical Data Management, Regulatory Requirements, Oncology, Clinical Operations, SOP
Education
Western Carolina University 2002 — 2005
MPM, Project Management
Duke University 1993 — 1997
B.S., Biology
Craig Zerbe's Clinsys Clinical Research Experience September 2008 - April 2010
Job Senior Clinical Research Associate
Industry Pharmaceuticals
Experience
Craig Zerbe November 2012 - February 2013
Craig Zerbe, CCRP 2002 - 2013
Craig Zerbe 2002 - 2013
Novalla Clinical Resourcing July 2011 - September 2012
Craig Zerbe April 2010 - July 2011
Clinsys Clinical Research September 2008 - April 2010
INC Research 2004 - September 2008
Skills
EDC, CRO, CTMS, GCP, Clinical Trials, Clinical Development, Oncology, Dermatology, Clinical Research, Cardiology, Clinical Monitoring, Pharmaceutical Industry
Education
Durham Technical Community College 1999 — 2002
Associate of Applied Science in Clinical Research, Cinical Research
University of Delaware
Craig Zerbe November 2012 - February 2013
Craig Zerbe, CCRP 2002 - 2013
Craig Zerbe 2002 - 2013
Novalla Clinical Resourcing July 2011 - September 2012
Craig Zerbe April 2010 - July 2011
Clinsys Clinical Research September 2008 - April 2010
INC Research 2004 - September 2008
Skills
EDC, CRO, CTMS, GCP, Clinical Trials, Clinical Development, Oncology, Dermatology, Clinical Research, Cardiology, Clinical Monitoring, Pharmaceutical Industry
Education
Durham Technical Community College 1999 — 2002
Associate of Applied Science in Clinical Research, Cinical Research
University of Delaware
Joan Davis-Grimes's Clinsys Clinical Research Experience July 2008 - March 2010
Job Clinical Research Monitor II
Industry Research
Experience
Clinsys Clinical Research July 2008 - March 2010
Paragon Biomedical June 2007 - June 2008
Quintiles Transnational May 2006 - July 2007
Education
Antioch University Midwest 1998 — 2000
MA, Business Management
University of Dayton 1981 — 1983
BS, Cytotechnology
Wilimigton 1975 — 1978
pre-vet science
Clinsys Clinical Research July 2008 - March 2010
Paragon Biomedical June 2007 - June 2008
Quintiles Transnational May 2006 - July 2007
Education
Antioch University Midwest 1998 — 2000
MA, Business Management
University of Dayton 1981 — 1983
BS, Cytotechnology
Wilimigton 1975 — 1978
pre-vet science
Karen Lewis's Clinsys Clinical Research Experience April 2011 - November 2011
Job Executive Director, Product Development, Clinical Operations and Project Management, Independent Consultant
Industry Pharmaceuticals
Experience
Independent Consultant December 2014 - Present
Akesis, LLC April 2014 - December 2014
Akesis, LLC June 2013 - April 2014
Salix Pharmaceuticals, Inc December 2011 - May 2013
Clinsys Clinical Research April 2011 - November 2011
Clinsys Clinical Research February 2010 - April 2011
Clinsys Clinical Research September 2009 - February 2010
PharmaNet April 2001 - September 2009
SFBC International 2001 - 2005
Otsuka America Pharmaceuticals 1991 - 2001
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, CRO, Dermatology, Biotechnology, Infectious Diseases, Ophthalmology, Clinical Development, Gastroenterology, CTMS, EDC, Strategy, Clinical Operations, Immunology, Pharmacovigilance, Regulatory Affairs, Drug Development, Clinical Monitoring, Therapeutic Areas, Regulatory Submissions, Oncology, Clinical Data Management, GCP, FDA, Protocol, Sop, ICH-GCP, Lifesciences, SOP
Education
The Johns Hopkins University 1997 — 2001
Masters of Science, Biotechnology
University of North Carolina at Chapel Hill 1983 — 1988
BS, Chemistry
Independent Consultant December 2014 - Present
Akesis, LLC April 2014 - December 2014
Akesis, LLC June 2013 - April 2014
Salix Pharmaceuticals, Inc December 2011 - May 2013
Clinsys Clinical Research April 2011 - November 2011
Clinsys Clinical Research February 2010 - April 2011
Clinsys Clinical Research September 2009 - February 2010
PharmaNet April 2001 - September 2009
SFBC International 2001 - 2005
Otsuka America Pharmaceuticals 1991 - 2001
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, CRO, Dermatology, Biotechnology, Infectious Diseases, Ophthalmology, Clinical Development, Gastroenterology, CTMS, EDC, Strategy, Clinical Operations, Immunology, Pharmacovigilance, Regulatory Affairs, Drug Development, Clinical Monitoring, Therapeutic Areas, Regulatory Submissions, Oncology, Clinical Data Management, GCP, FDA, Protocol, Sop, ICH-GCP, Lifesciences, SOP
Education
The Johns Hopkins University 1997 — 2001
Masters of Science, Biotechnology
University of North Carolina at Chapel Hill 1983 — 1988
BS, Chemistry
Olek Czepla's Clinsys Clinical Research Experience April 2002 - May 2006
Job Subhead TA OON GCDM at Bayer HealthCare
Industry Pharmaceuticals
Experience
Bayer HealthCare July 2015 - Present
Bellerophon Therapeutics February 2014 - July 2015
Ikaria May 2006 - February 2014
Clinsys Clinical Research April 2002 - May 2006
Clinsys Clinical Research September 1997 - April 2002
Skills
Clinical Trials, Data Management, Pharmaceutical Industry, EDC, ICH-GCP, CRO, Clinical Data Management, GCP, Sop, CTMS, Clinical Development, CRF design, Oncology, 21 CFR Part 11, Inform, Oracle Clinical, CDISC
Education
University of Gdansk
MS, Econometrics and Statistics
Bayer HealthCare July 2015 - Present
Bellerophon Therapeutics February 2014 - July 2015
Ikaria May 2006 - February 2014
Clinsys Clinical Research April 2002 - May 2006
Clinsys Clinical Research September 1997 - April 2002
Skills
Clinical Trials, Data Management, Pharmaceutical Industry, EDC, ICH-GCP, CRO, Clinical Data Management, GCP, Sop, CTMS, Clinical Development, CRF design, Oncology, 21 CFR Part 11, Inform, Oracle Clinical, CDISC
Education
University of Gdansk
MS, Econometrics and Statistics
Lisa Krestalude's Clinsys Clinical Research Experience December 2007 - January 2010
Job Program Manager at Duke Clinical Research Institute
Industry Biotechnology
Experience
Duke Clinical Research Institute August 2014 - Present
Duke Clinical Research Institute August 2010 - July 2014
INC Research October 2009 - September 2010
Clinsys Clinical Research December 2007 - January 2010
PPD January 2007 - November 2007
Discovery Alliance International July 2005 - January 2007
Hematology Oncology Associates of CNY September 2002 - July 2005
Skills
EDC, Clinical Trials, CRO, Clinical Data Management, Oncology, Clinical Research, Data Management, CRF design, Medidata, Cancer, GCP, CTMS, ICH-GCP, Oracle Clinical, Clinical Development, Clinical Monitoring, CDISC, Protocol, Therapeutic Areas, 21 CFR Part 11, Sop, Inform, FDA, Infectious Diseases, Biotechnology, Software Documentation, Pharmacovigilance, SAS programming, Regulatory Submissions, Pharmaceutical Industry, Clinical Study Design
Education
State University of New York Empire State College 2003 — 2007
MA, Business & Policy Studies
Binghamton University 1990 — 1993
BS, Biological Sciences
Duke Clinical Research Institute August 2014 - Present
Duke Clinical Research Institute August 2010 - July 2014
INC Research October 2009 - September 2010
Clinsys Clinical Research December 2007 - January 2010
PPD January 2007 - November 2007
Discovery Alliance International July 2005 - January 2007
Hematology Oncology Associates of CNY September 2002 - July 2005
Skills
EDC, Clinical Trials, CRO, Clinical Data Management, Oncology, Clinical Research, Data Management, CRF design, Medidata, Cancer, GCP, CTMS, ICH-GCP, Oracle Clinical, Clinical Development, Clinical Monitoring, CDISC, Protocol, Therapeutic Areas, 21 CFR Part 11, Sop, Inform, FDA, Infectious Diseases, Biotechnology, Software Documentation, Pharmacovigilance, SAS programming, Regulatory Submissions, Pharmaceutical Industry, Clinical Study Design
Education
State University of New York Empire State College 2003 — 2007
MA, Business & Policy Studies
Binghamton University 1990 — 1993
BS, Biological Sciences
Sandra Saadeh's Clinsys Clinical Research Experience December 2008 - July 2010
Job Senior Clinical Manager at Premier Research
Industry Pharmaceuticals
Experience
Premier Research June 2014 - Present
Jubilant Clinsys October 2013 - May 2014
Jubilant Clinsys Inc. July 2010 - October 2013
Clinsys Clinical Research December 2008 - July 2010
ACRP Lower Cape Fear Chapter 2008 - 2010
ZARS Pharma 2006 - 2008
NHRMC Zimmer Cancer Center 2003 - 2006
Purdue Pharma 1999 - 2002
PPD 1990 - 1999
Skills
Clinical Monitoring, EDC, CRO, CTMS, Clinical Trials, GCP, Clinical Research, Therapeutic Areas, Clinical Development, ICH-GCP, Sop, Oncology, Protocol, Pharmaceutical Industry, Trial Management, Regulatory Affairs, Infectious Diseases, Phase I, FDA, Biotechnology, Clinical Research..., Regulatory Submissions, Clinical Operations, Clinical Data Management, Dermatology, Pharmacovigilance, Drug Development, Medical Writing, Oracle Clinical, CRF design, Diabetes, Inform, Patient Recruitment, Hematology, Endocrinology, Neurology
Education
East Carolina University 1986 — 1988
MA, Adult Education
Moravian College 1983 — 1985
BS MT, Medical Technology/Laboratory Medicine
University of North Carolina at Wilmington 1972 — 1975
BS, Biology; Pre-Med
John T. Hoggard 1969 — 1972
Premier Research June 2014 - Present
Jubilant Clinsys October 2013 - May 2014
Jubilant Clinsys Inc. July 2010 - October 2013
Clinsys Clinical Research December 2008 - July 2010
ACRP Lower Cape Fear Chapter 2008 - 2010
ZARS Pharma 2006 - 2008
NHRMC Zimmer Cancer Center 2003 - 2006
Purdue Pharma 1999 - 2002
PPD 1990 - 1999
Skills
Clinical Monitoring, EDC, CRO, CTMS, Clinical Trials, GCP, Clinical Research, Therapeutic Areas, Clinical Development, ICH-GCP, Sop, Oncology, Protocol, Pharmaceutical Industry, Trial Management, Regulatory Affairs, Infectious Diseases, Phase I, FDA, Biotechnology, Clinical Research..., Regulatory Submissions, Clinical Operations, Clinical Data Management, Dermatology, Pharmacovigilance, Drug Development, Medical Writing, Oracle Clinical, CRF design, Diabetes, Inform, Patient Recruitment, Hematology, Endocrinology, Neurology
Education
East Carolina University 1986 — 1988
MA, Adult Education
Moravian College 1983 — 1985
BS MT, Medical Technology/Laboratory Medicine
University of North Carolina at Wilmington 1972 — 1975
BS, Biology; Pre-Med
John T. Hoggard 1969 — 1972
Angela Brinson Hoke, MBA, PMP, CSM's Clinsys Clinical Research Experience December 2008 - January 2011
Job Manager, Business Solutions at FHI 360
Industry Hospital & Health Care
Experience
FHI 360 February 2014 - Present
FHI 360 November 2011 - February 2014
Duke Clinical Research Institute October 2010 - October 2011
Clinsys Clinical Research December 2008 - January 2011
INC Research 2004 - 2008
Skills
CTMS, Project Management, Management, CRO, Clinical Trials, Business Strategy, Clinical Development, Budgets, Business Process, Quality Assurance, Clinical Research, 21 CFR Part 11, Program Management, GCP, Pharmaceutical Industry, Integration, EDC, Project Portfolio..., SDLC, Project Delivery
Education
North Carolina State University - College of Management
Master of Business Administration (M.B.A.)
University of North Carolina at Chapel Hill
Bachelor’s Degree
FHI 360 February 2014 - Present
FHI 360 November 2011 - February 2014
Duke Clinical Research Institute October 2010 - October 2011
Clinsys Clinical Research December 2008 - January 2011
INC Research 2004 - 2008
Skills
CTMS, Project Management, Management, CRO, Clinical Trials, Business Strategy, Clinical Development, Budgets, Business Process, Quality Assurance, Clinical Research, 21 CFR Part 11, Program Management, GCP, Pharmaceutical Industry, Integration, EDC, Project Portfolio..., SDLC, Project Delivery
Education
North Carolina State University - College of Management
Master of Business Administration (M.B.A.)
University of North Carolina at Chapel Hill
Bachelor’s Degree
Michael Ceglio's Clinsys Clinical Research Experience June 2009 - December 2009
Job Clinical Data Associate II at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences February 2013 - Present
Datatrial June 2011 - December 2012
Clinforce, LLC (Parexel Contract) March 2010 - July 2010
Clinsys Clinical Research June 2009 - December 2009
ALMAC-Clinical Services October 2008 - March 2009
PPD March 2008 - September 2008
PPD May 2007 - February 2008
PPD October 2006 - May 2007
Skills
GCP, Medidata, Oracle Clinical, Database Administration, Clinical Data Management, Excel, Word, Windows, MS Project, Livelink, RightFax, Data Management, Validation, Data Entry, Clinical, EDC, SAS, Clinical Trials, Clinical Trial..., Microsoft Office, PowerPoint, Clinical Research, CRO, Oncology, ICH-GCP, Clinical Study Design, Pharmaceutical Industry, Biotechnology, Biostatistics, Infectious Diseases, Regulatory Affairs, CRF design, Trial Management, Data Validation
Education
University of North Florida - College of Business Administration
BA, Business Administration and Management, General
Gilead Sciences February 2013 - Present
Datatrial June 2011 - December 2012
Clinforce, LLC (Parexel Contract) March 2010 - July 2010
Clinsys Clinical Research June 2009 - December 2009
ALMAC-Clinical Services October 2008 - March 2009
PPD March 2008 - September 2008
PPD May 2007 - February 2008
PPD October 2006 - May 2007
Skills
GCP, Medidata, Oracle Clinical, Database Administration, Clinical Data Management, Excel, Word, Windows, MS Project, Livelink, RightFax, Data Management, Validation, Data Entry, Clinical, EDC, SAS, Clinical Trials, Clinical Trial..., Microsoft Office, PowerPoint, Clinical Research, CRO, Oncology, ICH-GCP, Clinical Study Design, Pharmaceutical Industry, Biotechnology, Biostatistics, Infectious Diseases, Regulatory Affairs, CRF design, Trial Management, Data Validation
Education
University of North Florida - College of Business Administration
BA, Business Administration and Management, General
Rick Palma's Clinsys Clinical Research Experience April 2009 - December 2011
Job Project Manager, MedSource
Industry Pharmaceuticals
Experience
MedSource January 2012 - Present
Clinsys Clinical Research April 2009 - December 2011
King Pharmaceuticals, Inc. June 2008 - March 2009
PharmaNet October 2006 - June 2008
PPD August 2004 - October 2006
Verizon 2000 - 2004
Skills
CRO, Clinical Trials, Protocol, Clinical Research, Clinical Operations, Pharmaceutics, Leadership, CTMS, Management, GCP, EDC, ICH-GCP, Clinical Monitoring, Drug Development, Therapeutic Areas
Education
Northeastern University 1990 — 1994
BS, Cardiovascular Health Science
MedSource January 2012 - Present
Clinsys Clinical Research April 2009 - December 2011
King Pharmaceuticals, Inc. June 2008 - March 2009
PharmaNet October 2006 - June 2008
PPD August 2004 - October 2006
Verizon 2000 - 2004
Skills
CRO, Clinical Trials, Protocol, Clinical Research, Clinical Operations, Pharmaceutics, Leadership, CTMS, Management, GCP, EDC, ICH-GCP, Clinical Monitoring, Drug Development, Therapeutic Areas
Education
Northeastern University 1990 — 1994
BS, Cardiovascular Health Science
Edwin Nunez's Clinsys Clinical Research Experience January 1997 - April 2008
Job Technical Specialist at Medidata Solutions
Industry Pharmaceuticals
Experience
Medidata Solutions September 2013 - Present
Daiichi Sankyo October 2012 - May 2013
Daiichi Sankyo 2012 - 2013
Clinsys Clinical Research January 1997 - April 2008
Skills
Microsoft Excel, CRO, GCP, Databases, Data Entry, Validation, Data Management, CTMS, Clinical Trials
Education
Union County College
Medidata Solutions September 2013 - Present
Daiichi Sankyo October 2012 - May 2013
Daiichi Sankyo 2012 - 2013
Clinsys Clinical Research January 1997 - April 2008
Skills
Microsoft Excel, CRO, GCP, Databases, Data Entry, Validation, Data Management, CTMS, Clinical Trials
Education
Union County College
Anthony Abruzzini's Clinsys Clinical Research Experience April 2007 - December 2007
Job Vice President, Quintiles Advisory Services, Strategic Drug Development
Industry Pharmaceuticals
Experience
Quintiles December 2007 - Present
Clinsys Clinical Research April 2007 - December 2007
INC Research April 2004 - April 2007
Encelle, Inc. 2001 - April 2004
Quintiles 1992 - 2001
Cardiovascular Diagnostics, Inc. 1989 - 1992
Pitman-Moore, Inc. 1985 - 1988
Jewish Hospital of St. Louis / Washington University Medical Center 1980 - 1985
Skills
Immunoassays, Pharmaceutical Industry, Clinical Research, FDA, Biotechnology, Clinical Development, Cross-functional Team..., Oncology, Biopharmaceuticals, Regulatory Submissions, Informatics, Vaccines, CTMS, Immunology, Regulatory Affairs, Drug Development, Therapeutic Areas, Sop, Infectious Diseases, Science, Business Development, CRO, GCP, EDC, Clinical Data Management, Management, Biologics, Cell, Program Management, Clinical Trials, Strategy, Product Launch, Strategic Planning, Healthcare, Product Development, Entrepreneurship, Lifesciences, Medical Devices, Medicine, Data Management, Pharmacovigilance, Business Strategy, Risk Assessment, Validation
Education
University of Florida College of Medicine 1975 — 1980
Ph.D., Immunology and Medical Microbiology
The Johns Hopkins University 1973 — 1976
M.S.E., Environmental Biology
The Johns Hopkins University 1971 — 1973
B.A., Natural Sciences
Quintiles December 2007 - Present
Clinsys Clinical Research April 2007 - December 2007
INC Research April 2004 - April 2007
Encelle, Inc. 2001 - April 2004
Quintiles 1992 - 2001
Cardiovascular Diagnostics, Inc. 1989 - 1992
Pitman-Moore, Inc. 1985 - 1988
Jewish Hospital of St. Louis / Washington University Medical Center 1980 - 1985
Skills
Immunoassays, Pharmaceutical Industry, Clinical Research, FDA, Biotechnology, Clinical Development, Cross-functional Team..., Oncology, Biopharmaceuticals, Regulatory Submissions, Informatics, Vaccines, CTMS, Immunology, Regulatory Affairs, Drug Development, Therapeutic Areas, Sop, Infectious Diseases, Science, Business Development, CRO, GCP, EDC, Clinical Data Management, Management, Biologics, Cell, Program Management, Clinical Trials, Strategy, Product Launch, Strategic Planning, Healthcare, Product Development, Entrepreneurship, Lifesciences, Medical Devices, Medicine, Data Management, Pharmacovigilance, Business Strategy, Risk Assessment, Validation
Education
University of Florida College of Medicine 1975 — 1980
Ph.D., Immunology and Medical Microbiology
The Johns Hopkins University 1973 — 1976
M.S.E., Environmental Biology
The Johns Hopkins University 1971 — 1973
B.A., Natural Sciences
Natasha Tavahen's Clinsys Clinical Research Experience 2006 - 2010
Job Manager, Clinical Data Management at Novartis
Industry Pharmaceuticals
Experience
Novartis October 2014 - Present
Novartis June 2010 - October 2014
Clinsys Clinical Research 2006 - 2010
TKL Research 2003 - 2006
Education
D'Amore-McKim School of Business at Northeastern University 2007 — 2010
MBA, Marketing, International Management
University of Scranton 1999 — 2003
B.S, Biology
Novartis October 2014 - Present
Novartis June 2010 - October 2014
Clinsys Clinical Research 2006 - 2010
TKL Research 2003 - 2006
Education
D'Amore-McKim School of Business at Northeastern University 2007 — 2010
MBA, Marketing, International Management
University of Scranton 1999 — 2003
B.S, Biology
Scott Rosenberger's Clinsys Clinical Research Experience August 1998 - June 2009
Job Sr. Director, Clinical Monitoring Operations, Chiltern International
Industry Pharmaceuticals
Experience
Covance April 2012 - March 2015
Integrium June 2009 - November 2011
Clinsys Clinical Research August 1998 - June 2009
Wyeth September 1989 - August 1998
Skills
Clinical Trial..., CTMS, EDC, CRO, GCP, Clinical Research, Clinical Trials, Therapeutic areas, Clinical Development, Endocrinology, Dermatology, Clinical, Nephrology, Cardiology, Diabetes, Clinical Monitoring, Pharmaceuticals, Pediatrics, Data Management, Clinical Data Management, Protocol Development, Phase I, Asthma, Gastroenterology, SOP, Allergy, Research, Protocol
Education
University of Delaware 1985 — 1989
BS, Medical Technology (ASCP)
Covance April 2012 - March 2015
Integrium June 2009 - November 2011
Clinsys Clinical Research August 1998 - June 2009
Wyeth September 1989 - August 1998
Skills
Clinical Trial..., CTMS, EDC, CRO, GCP, Clinical Research, Clinical Trials, Therapeutic areas, Clinical Development, Endocrinology, Dermatology, Clinical, Nephrology, Cardiology, Diabetes, Clinical Monitoring, Pharmaceuticals, Pediatrics, Data Management, Clinical Data Management, Protocol Development, Phase I, Asthma, Gastroenterology, SOP, Allergy, Research, Protocol
Education
University of Delaware 1985 — 1989
BS, Medical Technology (ASCP)
Katie Melton's Clinsys Clinical Research Experience 2009 - 2010
Job Sr. Clinical Project Manager / UCB BioScience, Inc
Industry Research
Experience
Trio Clinical Research May 2010 - November 2011
Clinsys Clinical Research 2009 - 2010
i3 Consulting Group April 2008 - April 2009
Trio Clinical Research April 2007 - April 2008
PPD April 2003 - April 2007
ClinTrials Research 1992 - 1997
Education
Fairmont State University 1984 — 1988
BS, Criminal Justice / Psychology
Trio Clinical Research May 2010 - November 2011
Clinsys Clinical Research 2009 - 2010
i3 Consulting Group April 2008 - April 2009
Trio Clinical Research April 2007 - April 2008
PPD April 2003 - April 2007
ClinTrials Research 1992 - 1997
Education
Fairmont State University 1984 — 1988
BS, Criminal Justice / Psychology
Tara Johnson's Clinsys Clinical Research Experience March 2008 - May 2009
Job Sr. Manager Pharmacovigilance at Allergan
Industry Pharmaceuticals
Experience
Genentech April 2013 - June 2014
CareFusion April 2012 - April 2013
Jubilant Clinsys April 2009 - November 2011
Clinsys Clinical Research March 2008 - May 2009
PPD February 2007 - March 2008
PPD July 2006 - February 2007
Skills
Regulatory Affairs, Phase I, Auditing, Healthcare, GCP, Microsoft Word, Medicine, Clinical Monitoring, Therapeutic Areas, Clinical Operations, Microsoft Excel, Clinical Data Management, Regulatory Submissions, Pharmacovigilance, ISO 13485, Biotechnology, Compliance, Internal Audit, Outsourcing, Project Management, Risk Assessment, R&D, Manufacturing, Drug Safety, Oncology, Dermatology, Neurology, Quality Assurance, Clinical Research, Clinical Trials, Sop, FDA, CTMS, EDC, CRO, ICH-GCP, Protocol, CRF design, Clinical Development, Medical Devices, CAPA, Quality System, Biopharmaceuticals, GMP, SAE Reconciliation, Cancer, Hematology, 21 CFR Part 11, Pharmaceutical Industry, Diabetes
Education
Holy Family University
BSN, Nursing
Bucks County Community College
AD, Nursing
Genentech April 2013 - June 2014
CareFusion April 2012 - April 2013
Jubilant Clinsys April 2009 - November 2011
Clinsys Clinical Research March 2008 - May 2009
PPD February 2007 - March 2008
PPD July 2006 - February 2007
Skills
Regulatory Affairs, Phase I, Auditing, Healthcare, GCP, Microsoft Word, Medicine, Clinical Monitoring, Therapeutic Areas, Clinical Operations, Microsoft Excel, Clinical Data Management, Regulatory Submissions, Pharmacovigilance, ISO 13485, Biotechnology, Compliance, Internal Audit, Outsourcing, Project Management, Risk Assessment, R&D, Manufacturing, Drug Safety, Oncology, Dermatology, Neurology, Quality Assurance, Clinical Research, Clinical Trials, Sop, FDA, CTMS, EDC, CRO, ICH-GCP, Protocol, CRF design, Clinical Development, Medical Devices, CAPA, Quality System, Biopharmaceuticals, GMP, SAE Reconciliation, Cancer, Hematology, 21 CFR Part 11, Pharmaceutical Industry, Diabetes
Education
Holy Family University
BSN, Nursing
Bucks County Community College
AD, Nursing
Angela Nixon Neal's Clinsys Clinical Research Experience June 2002 - August 2006
Job Regional CRA at DSP Clinical Research
Industry Pharmaceuticals
Experience
DSP Clinical Research November 2008 - Present
Nixon Neal Research April 2006 - November 2008
INC Research August 2006 - April 2007
Target Research/Clinsys July 2002 - August 2006
Clinsys Clinical Research June 2002 - August 2006
Quintiles June 2000 - June 2002
Dr. Kerry J. Neal, DDS January 1997 - June 2000
Allergan Pharmaceuticals December 1995 - January 1997
PPD June 1992 - December 1995
Education
St. Edward's University 1989 — 1992
MAHS, Health Care Administration
Del Valle High School 1972 — 1976
DSP Clinical Research November 2008 - Present
Nixon Neal Research April 2006 - November 2008
INC Research August 2006 - April 2007
Target Research/Clinsys July 2002 - August 2006
Clinsys Clinical Research June 2002 - August 2006
Quintiles June 2000 - June 2002
Dr. Kerry J. Neal, DDS January 1997 - June 2000
Allergan Pharmaceuticals December 1995 - January 1997
PPD June 1992 - December 1995
Education
St. Edward's University 1989 — 1992
MAHS, Health Care Administration
Del Valle High School 1972 — 1976
Nicole Brown McGee's Clinsys Clinical Research Experience February 2008 - March 2010
Job Site StartUp Specialist at Quintiles
Industry
Experience
Health Decisions 2012 - 2012
Quintiles September 2010 - March 2011
PAREXEL 2011 - 2011
Clinsys Clinical Research February 2008 - March 2010
Pharmanet 2006 - 2008
Education
LSU Shreveport 1994 — 1996
Education
Health Decisions 2012 - 2012
Quintiles September 2010 - March 2011
PAREXEL 2011 - 2011
Clinsys Clinical Research February 2008 - March 2010
Pharmanet 2006 - 2008
Education
LSU Shreveport 1994 — 1996
Education
Cheryl Arvay's Clinsys Clinical Research Experience October 2002 - March 2010
Job Senior Project Manager at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2012 - Present
i3 Research May 2010 - January 2012
Clinsys Clinical Research October 2002 - March 2010
Schering-Plough Research Institute December 1991 - October 2002
Skills
CRO, Clinical Trial..., Protocol Development, GCP, Clinical Development, Clinical Research, EDC, Clinical Trials, Oncology, Infectious Diseases, Asthma, SOP, Pharmaceuticals, Neurology, Cardiology, Healthcare, Cross-functional Team..., Clinical Monitoring, Nursing
Education
University of Pittsburgh 1987 — 1991
MPH, Epidemiology
Carlow College 1973 — 1977
BSN, Nursing
PAREXEL March 2012 - Present
i3 Research May 2010 - January 2012
Clinsys Clinical Research October 2002 - March 2010
Schering-Plough Research Institute December 1991 - October 2002
Skills
CRO, Clinical Trial..., Protocol Development, GCP, Clinical Development, Clinical Research, EDC, Clinical Trials, Oncology, Infectious Diseases, Asthma, SOP, Pharmaceuticals, Neurology, Cardiology, Healthcare, Cross-functional Team..., Clinical Monitoring, Nursing
Education
University of Pittsburgh 1987 — 1991
MPH, Epidemiology
Carlow College 1973 — 1977
BSN, Nursing
Jillian Chapas-Reed's Clinsys Clinical Research Experience August 2005 - June 2006
Job Director of Clinical Operations at iCeutica
Industry Pharmaceuticals
Experience
iCeutica March 2015 - Present
PAREXEL February 2014 - February 2015
ICON plc April 2013 - February 2014
ICON plc June 2011 - April 2013
ICON Clinical Research March 2010 - August 2011
ICON plc June 2006 - March 2010
Clinsys Clinical Research August 2005 - June 2006
AstraZeneca October 2000 - August 2005
Chimeric Therapies, Inc. November 1999 - November 2000
INO Therapeutics February 1998 - December 1999
Skills
Transplant, Infection, Respiration, CTMS, CRO, Clinical Trials, Oncology, Drug Development, Clinical Operations, Clinical Study Design, Neurology, Clinical Monitoring, Vaccines, Clinical Development, Clinical Research, ICH-GCP, Pharmaceutical Industry, GCP, EDC, SOP, Regulatory Submissions, FDA, Clinical Data Management, Therapeutic Areas
Education
Hightstown High School
Hightstown High School
Juniata College
Bachelor of Science (BS), Biopsychology
Temple University
MS, Quality Assurance and Regulatory Affairs
iCeutica March 2015 - Present
PAREXEL February 2014 - February 2015
ICON plc April 2013 - February 2014
ICON plc June 2011 - April 2013
ICON Clinical Research March 2010 - August 2011
ICON plc June 2006 - March 2010
Clinsys Clinical Research August 2005 - June 2006
AstraZeneca October 2000 - August 2005
Chimeric Therapies, Inc. November 1999 - November 2000
INO Therapeutics February 1998 - December 1999
Skills
Transplant, Infection, Respiration, CTMS, CRO, Clinical Trials, Oncology, Drug Development, Clinical Operations, Clinical Study Design, Neurology, Clinical Monitoring, Vaccines, Clinical Development, Clinical Research, ICH-GCP, Pharmaceutical Industry, GCP, EDC, SOP, Regulatory Submissions, FDA, Clinical Data Management, Therapeutic Areas
Education
Hightstown High School
Hightstown High School
Juniata College
Bachelor of Science (BS), Biopsychology
Temple University
MS, Quality Assurance and Regulatory Affairs
Jackie Shaw's Clinsys Clinical Research Experience 1998 - 2009
Job Director, Clinical Operations at Prosoft Clinical
Industry Pharmaceuticals
Experience
Prosoft Clinical December 2012 - Present
PAREXEL April 2012 - December 2012
Auxilium Pharmaceuticals March 2011 - January 2012
Graceway Pharmaceuticals March 2009 - February 2011
Clinsys Clinical Research 1998 - 2009
Clinsys Clinical Research (formerly Target Research Associate) 1998 - 2009
Target Research Associates 1998 - 2009
IBRD Rostrum Global 1994 - 1998
US Food and Drug Administration 1990 - 1994
Skills
CTMS, CRO, EDC, Clinical Development, Clinical Trials, GCP, Oncology, Pharmaceutical Industry, Infectious Diseases, Clinical Monitoring, Clinical Research, Dermatology, Protocol, Clinical Data Management, ICH-GCP, Sop, Therapeutic Areas, Neurology, Cardiology, Lifesciences
Education
College 1984 — 1989
BS Biological Sciences, Biology
University of Pittsburgh 1984 — 1989
BS Biological Sciences, Biology
Prosoft Clinical December 2012 - Present
PAREXEL April 2012 - December 2012
Auxilium Pharmaceuticals March 2011 - January 2012
Graceway Pharmaceuticals March 2009 - February 2011
Clinsys Clinical Research 1998 - 2009
Clinsys Clinical Research (formerly Target Research Associate) 1998 - 2009
Target Research Associates 1998 - 2009
IBRD Rostrum Global 1994 - 1998
US Food and Drug Administration 1990 - 1994
Skills
CTMS, CRO, EDC, Clinical Development, Clinical Trials, GCP, Oncology, Pharmaceutical Industry, Infectious Diseases, Clinical Monitoring, Clinical Research, Dermatology, Protocol, Clinical Data Management, ICH-GCP, Sop, Therapeutic Areas, Neurology, Cardiology, Lifesciences
Education
College 1984 — 1989
BS Biological Sciences, Biology
University of Pittsburgh 1984 — 1989
BS Biological Sciences, Biology
Angela Nixon-Neal's Clinsys Clinical Research Experience June 2002 - April 2006
Job Regional Senior CRA at Salix Pharmaceuticals
Industry Pharmaceuticals
Experience
Salix Pharmaceuticals January 2013 - Present
ICON plc June 2012 - August 2012
DSP Clinical Research April 2007 - May 2012
Clinsys Clinical Research June 2002 - April 2006
Quintiles January 2000 - June 2002
Allergan January 1996 - January 1998
Pharmaco LSR May 1992 - January 1996
Skills
EDC, CTMS, GCP, CRO, Clinical Trials, Clinical Monitoring, Therapeutic Areas, Clinical Data Management, Oncology, Phase I, ICH-GCP, Clinical Development, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Drug Development, Inform, Regulatory Submissions, Clinical Operations, Regulatory Affairs, Data Management, Sop, Protocol, Neurology, 21 CFR Part 11, Vaccines, Endocrinology, Pharmacovigilance, Medical Writing, Patient Recruitment, Oracle Clinical, FDA
Education
St. Edward's University 1982 — 1992
BA, MAHS, Social Work, Health Care Admin.
Del Valle
Salix Pharmaceuticals January 2013 - Present
ICON plc June 2012 - August 2012
DSP Clinical Research April 2007 - May 2012
Clinsys Clinical Research June 2002 - April 2006
Quintiles January 2000 - June 2002
Allergan January 1996 - January 1998
Pharmaco LSR May 1992 - January 1996
Skills
EDC, CTMS, GCP, CRO, Clinical Trials, Clinical Monitoring, Therapeutic Areas, Clinical Data Management, Oncology, Phase I, ICH-GCP, Clinical Development, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Drug Development, Inform, Regulatory Submissions, Clinical Operations, Regulatory Affairs, Data Management, Sop, Protocol, Neurology, 21 CFR Part 11, Vaccines, Endocrinology, Pharmacovigilance, Medical Writing, Patient Recruitment, Oracle Clinical, FDA
Education
St. Edward's University 1982 — 1992
BA, MAHS, Social Work, Health Care Admin.
Del Valle
Alana Harrison's Clinsys Clinical Research Experience March 2008 - March 2011
Job Clinical Data Associate at Triangle Biostatistics, ARH Data Consulting, LLC
Industry Research
Experience
Triangle Biostatistics, LLC April 2013 - Present
Jubilant Clinsys March 2011 - April 2013
Clinsys Clinical Research March 2008 - March 2011
INC Research September 2007 - March 2008
PPD December 2006 - September 2007
Charles River Laboratories June 2005 - December 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, English, Research, Windows, Outlook, Budgets, CRF design, Clinical Data Management, Clinical Data
Education
North Carolina State University 1998 — 2003
Biology/Biological Sciences, General
Triangle Biostatistics, LLC April 2013 - Present
Jubilant Clinsys March 2011 - April 2013
Clinsys Clinical Research March 2008 - March 2011
INC Research September 2007 - March 2008
PPD December 2006 - September 2007
Charles River Laboratories June 2005 - December 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, English, Research, Windows, Outlook, Budgets, CRF design, Clinical Data Management, Clinical Data
Education
North Carolina State University 1998 — 2003
Biology/Biological Sciences, General
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY