Remote Senior Clinical Study Manager – Global Trials Lead

Takeda; United States; Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to lead study strategy and oversee execution of clinical trials remotely from Massachusetts, reporting to the Clinical Operations Leadership team.

The role collaborates with Clinical Operations leads, CROs, and strategic partners to ensure studies meet ICH-GCP standards, stay on schedule and on budget, and remain inspection-ready throughout development and regulatory processes. Fluent business English is required.

Qualifications

• BS/BA in health-related, life sciences, or tech field.
• Advanced degrees may supplement experience.
• 6+ years in pharma/ CRO with 4+ years in clinical study management.
• Knowledge of US CFR, EU CTD, ICH GCP; awareness of local requirements.
• Strong project management, leadership, and communication skills.
• Fluent business English (oral and written).

Responsibilities

• Lead study operational strategy and oversee execution for assigned trials.
• Oversee CROs/partners to meet ICH-GCP and Takeda objectives.
• Plan and manage study budgets and external spend with finance.
• Ensure studies are inspection-ready and coordinate regulatory inspections.
• Mentor junior Clinical Study Managers and support COPL as needed.
• Collaborate with data management to align timelines for CSR.

Skills

Leadership

Project management

Clinical trial management

Regulatory knowledge

Communication skills

Team collaboration

English fluency

Education

BS/BA in health-related field

Advanced degree considered

Job description

Takeda is seeking a Lead Clinical Study Manager to lead study strategy and oversee execution of clinical trials remotely from Massachusetts, reporting to the Clinical Operations Leadership team.

The role collaborates with Clinical Operations leads, CROs, and strategic partners to ensure studies meet ICH-GCP standards, stay on schedule and on budget, and remain inspection-ready throughout development and regulatory processes. Fluent business English is required.