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| Clinical Study Manager NJ Open (J#45219) Title: Clinical Study Manager Company: Ockham Development Group Inc Responsibilities: - Candidate will have experience in managing all aspects of study progress from start-up to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines. - Candidate will have experience in coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing. - Candidate will be expected to collaborate with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team. - Candidate will have experience in oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality. - Candidate will be expected to communicate with study sites, proactively recognizes problem situations and inform team members to enable issue resolution. - Candidate will be preferred to have electronic data capture experience, particularly Inform, as a plus. - Candidate will be expected to contribute to individual and team development through training initiatives and team building activities. Requirements -Minimum 5 to 7 years experience in the pharmaceutical or related industry with on-site monitoring experience. -Strong communication skills. -Global experience a plus with respect to clinical research activities. -Bachelor s degree in biological science, nursing, pharmacy or equivalent as a minimum. -20% travel required. | |||
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