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Job #02162

About our client Our client is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products. Their principal programs are directed toward symptom management and supportive care, human immunodeficiency virus (HIV), infection and cancer. They have four product candidates in clinical development and several others in pre-clinical development. Position Location Associate Director, Clinical Research Operations 1 New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide strategic direction and guidance to internal teams within the clinical research as regards the management and GCP compliance of company sponsored clinical trials 2) Represent clinical operations on company initiatives and task force 3) Plan and manage the document control group and related GCP matters 4) Provide input into protocols, protocol amendments, and clinical study reports 5) Represent clinical research and chair on teams managing SOPs and working practices for the company 6) Oversee the preparation of project specific training programs and training materials for internal and external clinical teams 7) Manage team members including preparing evaluations and when appropriate, recommending corrective actions 8) Participate in process improvement activities Requirements 1) Degree in Life Sciences - advanced degree MS/MA preferred 2) Minimum 5-7 years' clinical research experience 3) In-depth knowledge of GCP, ICH guidelines and FDA regulations 4) Strong clinical trial management experience 5) Strong background - CRA, CTM, etc 6) Good understanding of the drug development process 7) Excellent software skills (MS Word, MS Project, Excel)