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Job #02604

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 Operations (GI) New Jersey Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Ensure that the therapeutic area is meeting the company's short and long-term goals with respect to monitoring/management of clinical trials in the Clinical Operations Group 2) Lead large global or multiple clinical studies within the group from protocol development and study management, to final analysis and submission within a therapeutic area 3) Identify potential challenges and work with the team to strategize possible solutions 4) Develop sound knowledge of a number of areas in the drug development process, including clinical plan development, study area and execution of the clinical study chain Requirements 1) Bachelor of Science in a relevant scientific discipline 2) 5+ yrs of experience in the pharmaceutical industry, including managing outsourcing to CROs and multiple vendors 3) Phase – III study experience (GI area) preferred 4) Knowledge of entire drug development process, including clinical plan development and execution of entire Clinical Study Plan 5) Detailed knowledge of Code of Federal regulation (CFRs), ICH Guidelines, project management and corporate/regional SOPs 6) Good organizational and time-management skills with good attention to detail 7) Extremely proficient computer skills, including MS Word, Excel and PowerPoint 8) Strong interpersonal communication (verbal and written) skills, especially in a cross-functional team environment (leading study teams) 9) Willingness to travel – up to 20%