Clinical Trial Manager / Senior Clinical Trial Manager

Role: Senior Clinical Operations Lead for complex cardiovascular trials, overseeing study execution from planning through close-out. Responsibilities: manage study budgets, vendor/vendor selection, site feasibility, activation and recruitment, monitor timelines, oversee site and vendor performance, review study plans, and ensure regulatory compliance. Provide strategic input on risk management, data review, and system UAT; mentor staff; contribute to SOPs and inspection readiness. Qualifications: B.S./B.A. in a relevant field; 7+ years of clinical operations experience, including 5+ years in industry, with expertise in GCP, FDA regulations, ICH, and electronic systems. Experience in Phase 2 and 3 global studies; knowledge of multiple therapeutic areas, especially cardio/rare/orphan diseases, preferred. HighValue: cardiovascular indications, complex adaptive designs, vendor oversight, global Phase 2/3, GCP/FDA compliance, systems UAT. Collaboration: cross-functional with Data Management, QA, Regulatory, and site teams. WorkSetup: not specified; likely hybrid or onsite based on typical roles.