Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07261 About our client Our client is a biotechnology company based in California. They focus on the research, development and commercialization of products to regulate gene therapy. These new technologies are used to fight diseases such as diabetes and HIV. With a strong pipeline of products in pre-clinical and clinical stages, this is an exciting time to join a fast-paced environment! Position Location Clinical Project Manager CA - North Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop, execute and manage clinical studies conducted 2) Write study protocol, informed consent, case report forms, study reports and summaries and other study-related documents 3) Evaluate and recommend selection of investigators/study sites and participate in identifying potential sites 4) Train investigators, Coordinator and other trial staff in data collection methods 5) Ensure collection of patient data is accurate, complete and conforms to project data standards and protocol requirements 6) Monitor and close out clinical studies, ensure adherence to protocol, accurate data collection on CRFs via comprehensive source document verification and device accountability 7) Ensure the collection and updating of all essential documents defined by FDA regulations, SOPs and general industry standards 8) Develop solutions for logistical and operational issues that arise during trials execution and communicate these in a timely fashion to investigators, coordinator and staff 9) Identify and prepare written reports for product complaints, serious or unexpected adverse events 10) Attend relevant scientific and/or medical meetings 11) Maintain a high level of professional expertise through familiarity with clinical literature and participates in project team meetings 12) Work with clinical data analysts and biostatisticians to maintain, analyze and report outcomes data 13) Prepare accurate and timely study reports and disseminate outcome results to clinical investigators, internal clinical personnel and external groups 14) Support company goals and objectives, policies and procedures, Good Clinical Practices and FDA and other notifying bodies’ regulations Requirements 1) BA/BS in Nursing, Pharmacy, Life Sciences or a health-related discipline 2) Minimum 8+ years of pharmaceutical industry experience including direct site management 3) People management experience 4) Thorough knowledge of GCP, ICH and FDA regulations 5) Strong organizational skills 6) Strong written and verbal communication skills 7) Self-motivated, assertive individual with ability to function independently or as part of a team 8) Strong interpersonal skills 9) Detail-oriented individual with ability to multi-task and work effectively in a fast-paced environment
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