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Regulatory Operations Manager - Gastrointestinal Oncology
Reporting to the CTO Associate Director of Regulatory Operations ??and specific assigned disease center(s), the Regulatory Operations Manager (ROM) is responsible for overseeing the disease group???s research portfolio; working collaboratively with other Regulatory Managers in their assigned regulatory POD, managing the development and quality control of protocol documents 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 sponsors, DFCI designated Principal Investigator and the disease group Clinica


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