Careers | Clincal Affairs Manager - Warsaw, IN

Summary

The Clinical Affairs Manager is responsible for defining and executing clinical strategy that will support meeting OrthoPediatrics’ commercialization objectives including, but not limited to, the post-market phase. Clinical trials / registries comprise the primary means by which the strategy culminates in proactive, ongoing evaluation of product safety and effectiveness through full compliance to Good Clinical Practice (GCP) and all other applicable regulatory requirements. The Clinical Affairs Manager will manage external vendors such as Contract Research Organizations (CRO), Core Labs, Medical Monitors, Data Management, and Biostatistics, as well as certain internal staff that may be hired as the clinical affairs function matures. The Clinical Affairs Manager, with input from the Chief Medical Officer, takes the leadership role for analysis and interpretation of clinical results for regulatory submissions, Clinical Evaluation Reports (CER) per the Medical Device Regulation requirements, abstracts and publications. This position reports to the VP, Regulatory Affairs.

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