Global Study Lead

Role: Senior Manager, Global Study Lead in Clinical Operations, overseeing the end-to-end execution of global clinical trials to ensure timely, within-budget, and compliant delivery. Responsibilities include leading cross-functional trial teams, managing trial timelines, budgets, quality, CRO/vendor oversight, risk mitigation, and ensuring regulatory adherence, including GCP and inspections. The role entails stakeholder engagement across functions such as Safety, Data Management, Quality, and Regulatory, with emphasis on continuous improvement and team mentorship. Qualifications: BS/BA, 7+ years in clinical research (CRO, biotech, pharma) with 3-5 years leading Phase 3 global trials, experience managing outsourced CRO activities, and strong project management and leadership skills. High-Value: experience with Phase 1-4, global trial oversight, CRO management, GCP compliance, and cross-functional stakeholder collaboration. Location: hybrid in Cambridge, MA or Philadelphia, PA, with approximately 10% travel required.