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| Clinical Study Manager Job MI Open (J#44961) Title: Clinical Study Manager Job Company: Stryker Job Description: The Clinical Study Manager (CSM) is responsible for the day-to-day management of one or more clinical studies, to include, Standard Operational Procedures (SOPs), protocol development, Investigational Device Exemption (IDE), post-approval, post-market surveillance, feasibility, marketing studies, and/or investigator initiated studies. The CSM is also responsible for ensuring that assigned studies are being conducted in accordance with GCPs, FDA, ISO, ICH regulations and department SOPs. The CSM must provide greater support to the clinical group by taking on more studies, or studies of greater complexity under limited supervision. The CSM must provide clinical study guidance to less experienced CSMs, RND, Marketing, Regulatory Affairs and other multi-disciplinary teams. - Read and comprehend medical literature in the subject field in order to act as clinical representative to physician advisors, FDA, NB, internal and external consultants, and other Stryker departments - Lead multi-disciplinary teams and/or clinical project team - Design, develop and write clinical study protocols in conjunction with physician advisors More... | |||
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