Lead Clinical Study Manager

Role: Lead Clinical Study Manager responsible for developing and executing operational strategies for assigned clinical trials within Takeda's pipeline, supporting clinical development plans. Responsibilities include overseeing study execution ensuring compliance with ICH GCP and local regulations, managing CROs and third-party vendors, and ensuring studies are on time, within budget, and inspection-ready. The role involves strategic planning, study budget management, vendor oversight, risk mitigation, and collaboration with cross-functional teams including Data Management and Regulatory. The manager also plays a key role in onboarding, mentoring, and representing the team in initiatives. Qualifications: Bachelor’s in health sciences or related field; 6+ years in pharma or CRO, with 4+ years in clinical study management, including Phase 2/3 or global studies, preferably across multiple therapeutic areas. Knowledge of global regulatory standards and excellent project management, communication, and leadership skills are required. Travel is expected at 5-20%, including international trips. Location: Remote in Massachusetts with flexible work arrangements.