Lead Clinical Study Manager

Role: Lead Clinical Study Manager overseeing strategic planning and execution of clinical trials within Takeda's clinical development programs. Responsibilities: manage study operational strategies, ensure compliance with GCP and regulations, oversee CROs and vendors, control budgets, facilitate site and country feasibility, and prepare for regulatory inspections. Lead study risk management, support study team onboarding, and represent the role in functional initiatives. Requirements: BS/BA in life sciences or related fields; 6+ years in pharma or CRO, with 4+ years in clinical study oversight, including early-phase or Phase 2/3 global studies. Knowledge of global regulatory standards and strong leadership in project management are essential. Preferred: experience across multiple therapeutic areas, advanced degrees, and familiarity with international regulations. HighValue: global clinical trials, Phase 2/3, cross-functional vendor oversight, risk management, compliance with ICH GCP, and international site management. WorkSetup: remote Massachusetts with 5-20% travel.