Lead Clinical Study Manager

Role: Lead Clinical Study Manager responsible for developing and overseeing operational strategies and execution of clinical trials within Takeda's clinical programs. Responsibilities include managing study planning, vendor oversight, ensuring compliance with quality standards (ICH GCP, local regulations), and maintaining study timelines and budgets. The role entails leading interactions with CROs and strategic partners, overseeing study risk management, and ensuring trial readiness for inspections. The manager provides expertise in protocol development, feasibility, site selection, and study conduct, alongside mentoring junior staff. Qualifications: BS/BA in life sciences or related field; 6+ years in pharma or CRO, with at least 4+ years in clinical study oversight, preferably in early or Phase 2/3 global studies across multiple therapeutic areas. Knowledge of global regulatory requirements, project management, and matrix leadership is essential. Preferred: advanced degrees, experience in multiple therapeutic areas, and familiarity with GxP standards. The position involves approximately 5-20% travel, including international visits. Location: remote with Massachusetts base salary range of $116,000-$182,270.