Global Study Lead

Role: Lead global clinical trial operations as Sr. Manager, overseeing planning, execution, and vendor management from start-up through closeout. Responsibilities: direct cross-functional teams, manage timelines, budgets, quality, and vendor relationships; identify and mitigate operational risks; ensure compliance with GCP and regulatory standards; support inspections and audits; drive process improvements; and mentor colleagues. Qualifications: BS/BAS degree; 7+ years in clinical research within CRO, biotech, or pharma; 3-5 years leading Phase 3 global trials; proven experience managing outsourced trials; strong decision-making, leadership, organizational, and communication skills; proficient in MS Office and project management tools. High-Value: extensive trial management experience in Phase 1-4, with emphasis on Phase 3 registrational studies, vendor oversight, and global trial execution. Collaboration with internal teams across functions such as Regulatory, Quality, Data Management, and Medical Affairs. Work setup: hybrid in Cambridge, MA or Philadelphia, PA, with ~10% travel; remote considered for exceptional candidates.