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Job #02605

About our client Our client is a human health care company. It’s on the lookout for ground-breaking solutions for preventing diseases, curing and caring for the health and well being of people. Position Location Manager – Clinical Quality Assurance New Jersey Salary Reports to Highly competitive package, commensurate with experience Senior Director, Clinical Quality Assurance Responsibilities 1) Co-ordinate and perform audits of clinical investigator sites and clinical vendors to support Medical affairs of Phase IV clinical research programs 2) Provide guidance to clinical personnel to ensure that research is conducted in compliance with GxPs 3) Support medical services by advising and either performing or coordinating periodic audits of pharmacovigilance and drug safety 4) Ensure compliance with GCPs 5) Act as a liaison during regulatory inspections Requirements 1) Bachelor’s degree in a scientific discipline 2) Minimum 5 years of experience in the pharmaceutical industry, in the area of Clinical Quality Assurance 3) Familiarity with pharmacovigilance and drug safety operations 4) Knowledge of US and International Regulatory Standards and guidelines of the conduct of clinical trials