Position Details:
Client Direct Client
Location Cambridge, MA
Job Title Senior Clinical Operation Lead
Duration 1year+ (possible extension)
Must have skill-set [Job Description] JOB RESPONSIBILITIES:
• Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols.
• Leverage Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy.
• Independently oversees one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner.
• Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
• Leverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues
• Ensure all operational aspects support end point integrity and data validity.
Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity.
• Leverages Phase expertise (e.g. Phase I, II, III, and IV), therapeutic knowledge, as well as internal and external data to develop protocols and expert operational strategy for one or more clinical studies.