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Senior Regulatory Operations Manager - Division of GYN Oncology
The Senior Regulatory Operations Manager (Sr. ROM) reports directly to the Clinical Trials Office Associate Director of Regulatory Operations.?? This position is responsible for overseeing the specific assigned disease group???s research portfolio and, when applicable, to share regulatory oversight within the assigned regulatory POD. The Sr. ROM will be responsible for managing the development and quality control of protocol documents preparation prior to IRIS submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS submission, review and approval timelines / institutional benchmarks are met.?? This position is the primary point person responsible for the collaboration / navigation with the DFCI IRB contacts, clinical trial spo
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