2007 -2008 Manager, Phase I and BA and BE Quality Assurance @
2005 -2007 Sr GCP Auditor and QA Project Manager @ MedTrials, Inc.
1999 -2000 Clinical Research Auditor @ Medex Clinical Trials (later acquired by Pharmanet)
Amanda Grim Education
Villanova University School of Law
JD (Health Care Law)
1996-1999
Davidson College
BA/AB (Medical Ethics)
1989-1993
Amanda Grim Skills
GCP
CAPA
Quality Assurance
Auditing
Documentation
FDA
SOP
Quality Systems
ISO 13485
Clinical Trials
Change Control
Quality Auditing
Clinical Research
ICH-GCP
Regulatory Requirements
CRO
IRB
EDC
Regulatory Affairs
Validation
Software Documentation
21 CFR Part 11
Quality System
Medical Devices
Protocol
Regulatory Submissions
Pharmaceutical Industry
GxP
Biotechnology
CTMS
Clinical Development
Pharmacovigilance
Clinical Monitoring
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Good Clinical Practice (GCP)
Corrective and Preventive Action (CAPA)
CRO Management
U.S. Title 21 CFR Part 11 Regulation
Standard Operating Procedure Sop
Strategic Planning
Ich Gcp
Process Improvement
u.s. Food and Drug Administration Fda
Program Management
Good Clinical Practice Gcp
Strategy
Corrective and Preventive Action Capa
Audits
Business Analysis
u.s. Food and Drug Administration
Standard Operating Procedure
Good Clinical Practice
Corrective and Preventive Action
Amanda Grim Summary
Amanda Grim, based in Carolina Beach, NC, US, is currently a CEO, Principal Consultant at Amanda Grim's GCP Audits, LLC. Amanda Grim brings experience from previous roles at Boston Scientific, AAIPharma, MedTrials, Inc. and Medex Clinical Trials (later acquired by Pharmanet). Amanda Grim holds a 1996 - 1999 JD in Health Care Law @ Villanova University School of Law. With a robust skill set that includes GCP, CAPA, Quality Assurance, Auditing, Documentation and more. Amanda Grim has 1 emails and 1 mobile phone numbers on RocketReach.
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