Monitoring Oversight Lead (Lead CRA)

Role: Lead CRA responsible for study and operational line management in clinical trials within a medical device company. Objectives include overseeing site management, ensuring regulatory compliance, and driving study milestones. Responsibilities: lead study-specific activities, manage site visits, monitor site performance, oversee CRO/vendor relations, mentor junior CRAs, and support study start-up and closure. Also, perform site monitoring duties similar to CRA IV level. Qualifications: 8+ years in clinical research monitoring, proficient in GxP, regulations (FDA, EU), and site management, with the ability to oversee 10-15 sites for Class 2-3 medical devices from start-up to closeout. Preferred: experience with cardiovascular devices or implantable therapies, and demonstrated leadership in complex clinical trials. HighValue: medical devices, cardiovascular/aortic indications, clinical phases from start-up to close, GxP compliance, site management, vendor oversight, and team leadership. WorkSetup: not specified.