Senior Clinical Study Manager Remote, Strategy & Delivery

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

Job summary

Takeda in the United States is seeking a Lead Clinical Study Manager to drive study operations from a remote location, reporting to the Clinical Operations Leadership team. The role emphasizes leading operational strategy, cross-functional collaboration, and ensuring studies are on time and on budget.

Responsibilities include oversight of protocol development, vendor management with CROs, budgeting, feasibility assessments, and ensuring regulatory compliance across global programs; strong

Qualifications

• 6+ years in pharmaceutical industry or CRO
• 4+ years in clinical study management/oversight
• Global/international trial experience advantageous
• Fluent business English (oral and written)

Responsibilities

• Lead study operational strategy and planning for assigned programs.
• Oversee execution of studies in compliance with ICH GCP and Takeda SOPs, on time and on budget.
• Manage Strategic Partners, CROs, and 3rd party vendors.
• Oversee budget planning and external spend; coordinate with Finance and Global Program Management.
• Ensure study readiness for inspections and regulatory processes.
• Mentor and onboard junior Clinical Study Managers.

Skills

Fluent English

Excellent communication

Teamwork & leadership

Education

BS/BA in health sciences or related field

Advanced degree (MS/PhD)

Job description

Takeda in the United States is seeking a Lead Clinical Study Manager to drive study operations from a remote location, reporting to the Clinical Operations Leadership team. The role emphasizes leading operational strategy, cross-functional collaboration, and ensuring studies are on time and on budget.

Responsibilities include oversight of protocol development, vendor management with CROs, budgeting, feasibility assessments, and ensuring regulatory compliance across global programs; strong