Remote Senior Clinical Study Manager

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of); United States; Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to drive study operations for an assigned clinical program, working remotely from Massachusetts in a virtual capacity. You will oversee CROs, budgets, and timelines, ensuring ICH-GCP compliance and strategic alignment with the development plan.

The role requires 6+ years in pharma/ CRO environments, strong cross-functional leadership, and fluency in business English. Travel 5–20% may be required to sites and partners globally.

Qualifications

• BS/BA in health-related field or equivalent; advanced degree may supplement experience.
• Demonstrated excellence in project/program management and leadership.
• Fluent business English (oral and written).
• Experience in global regulatory requirements for clinical research (US FDA, EU).

Responsibilities

• Lead study operational strategy and planning for assigned clinical program(s).
• Oversee execution of studies with CROs/vendors to meet timelines and budget.
• Ensure studies are compliant with ICH GCP and Takeda SOPs; participate in safety and data reviews.
• Manage budgets, enrollment, and country/site feasibility to align with program strategy.
• Mentor junior Clinical Study Managers and support cross-functional initiatives.

Skills

Communication skills

Teamwork

Problem solving

Fluent English

Leadership

Education

BS/BA in health-related field

Advanced degree (MS/PhD) may supplement

Job description

Takeda is seeking a Lead Clinical Study Manager to drive study operations for an assigned clinical program, working remotely from Massachusetts in a virtual capacity. You will oversee CROs, budgets, and timelines, ensuring ICH-GCP compliance and strategic alignment with the development plan.

The role requires 6+ years in pharma/ CRO environments, strong cross-functional leadership, and fluency in business English. Travel 5–20% may be required to sites and partners globally.