Senior Manager, Clinical Monitoring Oversight

The Senior Manager will be responsible for the overall oversight of clinical studies, ensuring the quality and integrity of risk-based monitoring deliverables. This involves developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) to detail strategies for maintaining high standards in monitoring activities. The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring.