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Manager II, Clinical Quality Assurance (GCP Auditing)Boehringer Ingelheim - Ridgefield, CTBASIC PURPOSE: Assess the compliance of BI clinical research activities with Good Clinical Practices, ICH guidelines, local regulations and company SOPs/WI. Communicate information relative to the quality of BI's clinical trials to management. DUTIES & RESPONSIBILITIES: Organize and implement an International Clinical QA activity plan for assigned products. Plan and conduct GCP audits of clinical research activities to assess compliance with applicable regulations, GCP and ICH guidelines, sponsor policies and procedures, study protocols and contracts; The incumbent will be responsible for conducting audits (both domestic and international) of clinical investigator sites, and vendors, including CROs, internal product, and system audits. The incumbent, when appropriate will also assess the compliance...originally from PharmaDiversityJobBoard.com - More Tools...
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