Sr. Director, Operations Pharmacovigilance @ (June 2001 - March 2009)
Director, Drug Safety Systems and Compliance @ (January 1999 - January 2001)
Drug Safety Associate Director @ (January 1998 - January 1999)
Drug Safety Systems Scientist @ (January 1996 - January 1998)
Drug Safety Manager @ (January 1995 - January 1996)
Clinical Information Center Supervisor @ (January 1994 - January 1995)
Clinical Information Coordinator @ (January 1993 - January 1994)
Chemist @ Research Triangle Laboratories (January 1987 - January 1989)
Chemist @ Roche Biomedical Laboratories (January 1985 - January 1987)
Lee Chaiken Education
Appalachian State University
BS (Chemistry, Concentration in Computer Science)
1981-1985
Lee Chaiken Skills
Pharmacovigilance
GCP
Clinical Data Management
CRO
Clinical Trials
Protocol
Pharmaceutical Industry
Drug Safety
FDA
Computer System Validation
IND
Clinical Research
Sop
ICH-GCP
Regulatory Submissions
21 CFR Part 11
CTMS
EDC
Standard Operating Procedure (SOP)
Good Clinical Practice (GCP)
U.S. Title 21 CFR Part 11 Regulation
CRO Management
Quality Assurance
Clinical Development
Cross-functional Team Leadership
Management
Biotechnology
Leadership
Software Development Life Cycle (SDLC)
Quality Control
Drug Development
Software Documentation
Training
Regulatory Affairs
Validation
Databases
Program Management
Ich Gcp
Good Clinical Practice Gcp
Adoption
Cross Functional Team Leadership
Standard Operating Procedure Sop
Software Development Life Cycle Sdlc
Good Clinical Practice
Standard Operating Procedure
Software Development Life Cycle
Lee Chaiken Summary
Lee Chaiken, based in Durham, NC, US, is currently a Chief People Officer at Perspective Pharmacovigilance, Inc.. Lee Chaiken brings experience from previous roles at Perspective Pharmacovigilance, Inc., Perspective PV and PrimeVigilance USA Inc.. Lee Chaiken holds a 1981 - 1985 BS in Chemistry, Concentration in Computer Science @ Appalachian State University. With a robust skill set that includes Pharmacovigilance, GCP, Clinical Data Management, CRO, Clinical Trials and more. Lee Chaiken has 1 emails and 3 mobile phone numbers on RocketReach.
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