Remote Lead Clinical Study Manager – Global Programs

Takeda Pharmaceutical Co.; Boston (MA); Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Lead Clinical Study Manager to lead the study operations strategy and execution for assigned programs. You will manage SETs, oversee CROs, and ensure delivery on time and within budget while maintaining ICH-GCP compliance.

The role requires extensive clinical development experience, strong communication, and budget management capabilities; travel may occur. The position is remote with US-based responsibilities and collaboration across global teams.

Qualifications

• BS/BA required in a health-related, life science, or technology field.
• 6+ years in pharma/clinical research, including 4+ years in study management.
• Advanced degree may supplement experience.
• Knowledge of global regulatory and ICH GCP requirements.

Responsibilities

• Lead the cross-functional study execution team (SET) to meet objectives on schedule and budget.
• Oversee STRATEGIC PARTNERS/CROs and vendors to meet ICH-GCP and Takeda objectives.
• Collaborate with other CSMs and study management colleagues as needed.
• Manage study budget and external spend; coordinate with Clinical Operations Program Leaders, Global Program Management and Finance.
• Ensure studies are inspection-ready and serve as SME during regulatory inspections.
• Onboard and mentor study management team members; support COPL where required.

Skills

Business English

Communication

Teamwork

Budgeting

Regulatory knowledge

Education

Bachelor's degree

Advanced degree

Job description

Takeda Pharmaceutical Co. is seeking a Lead Clinical Study Manager to lead the study operations strategy and execution for assigned programs. You will manage SETs, oversee CROs, and ensure delivery on time and within budget while maintaining ICH-GCP compliance.

The role requires extensive clinical development experience, strong communication, and budget management capabilities; travel may occur. The position is remote with US-based responsibilities and collaboration across global teams.