Global Study Lead

Role: Lead global clinical trial operations as Sr. Manager, overseeing planning, execution, and vendor management from start-up through closeout, ensuring compliance with GCP and regulatory standards. Responsibilities: direct cross-functional teams, manage trial timelines, budgets, quality, and milestones; oversee CRO/vendor selection and performance; identify and mitigate operational risks; ensure inspection readiness; contribute to process improvements; interface with internal stakeholders; and provide operational updates. Qualifications: BS/BA degree; 7+ years in clinical research with CRO, biotech, or pharma, including 3-5 years leading Phase 3 global trials; strong project management, decision-making, financial, and leadership skills; experience managing outsourced trials; proficiency in MS Office and project tools. High-Value: experience in Phase 1-4 trials, with a focus on global trial management, vendor oversight, and compliance; candidate preferred in biotech or pharmaceutical settings based in Cambridge, MA or Philadelphia, PA, with flexibility for remote work and approximately 10% travel.