Remote Lead Clinical Study Manager

Takeda Pharmaceutical Co.; Boston (MA); Remote; USD 116.000 - 182.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. in the United States is seeking a Lead Clinical Study Manager to drive study strategy and oversee execution of assigned clinical programs, reporting remotely to the Clinical Operations Leadership team.

You will partner with Clinical Operations Leads, manage budgets and CRO/vendor relationships, ensure compliance with ICH-GCP and global regulatory requirements, and mentor junior staff. Travel is required (approximately 5-20%), with work across sites and partner networks.

Qualifikationen

• BS/BA in health-related, life science, or technology field.
• Advanced degree may supplement experience.
• 6+ years in pharmaceutical industry or CRO with 4+ years clinical study management/oversight; global/international exposure.
• Experience in more than one therapeutic area is advantageous.
• Knowledge of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP) and local country requirements.
• Excellent communication, teamwork, problem-solving and matrix leadership.
• Fluent business English.

Aufgaben

• Lead study operational strategy, planning and oversee execution of clinical studies for assigned programs.
• Oversee CROs and vendors to meet ICH-GCP and Takeda objectives, on schedule and on budget.
• Ensure studies are inspection-ready and compliant with quality standards.
• Participate in country/site feasibility and alignment with program strategy.
• Manage budgets, enrollment and external spend; communicate status to leadership.
• Oversee vendor selection, budget, contracts and performance; escalate as needed.
• Provide onboarding and mentoring of new or junior CSMs.
• Support regulatory inspections and ensure coordination with data management plans.

Kenntnisse

Fluent business English

Excellent communication skills

Project management

Matrix leadership

Teamwork

Problem-solving

Ausbildung

BS/BA in health-related or life science or technology field

Advanced degree (MS/PhD) preferred

Jobbeschreibung

Takeda Pharmaceutical Co. in the United States is seeking a Lead Clinical Study Manager to drive study strategy and oversee execution of assigned clinical programs, reporting remotely to the Clinical Operations Leadership team.

You will partner with Clinical Operations Leads, manage budgets and CRO/vendor relationships, ensure compliance with ICH-GCP and global regulatory requirements, and mentor junior staff. Travel is required (approximately 5-20%), with work across sites and partner networks.