Remote Lead Clinical Study Manager

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

Job summary

Takeda is seeking a Lead Clinical Study Manager to work remotely with the Clinical Operations Leadership team. You will guide study strategy, oversee execution, budgets, and vendor relationships for multiple programs, ensuring ICH GCP compliance and on-time delivery.

You will mentor junior CSMs, coordinate with partners and CROs, and ensure studies are inspection-ready. Travel 5–20% is expected to sites and international partners.

Qualifications

• BS/BA in a health-related, life science or tech field is required.
• Advanced degrees may supplement experience.
• 6+ years in pharma/ CRO with 4+ years in clinical study management.
• Knowledge of global regulatory and compliance requirements (ICH GCP etc.).
• Demonstrated excellence in project/program management and leadership.
• Excellent communication skills and teamwork.

Responsibilities

• Lead study operational strategy and oversee execution of clinical studies.
• Oversee budgets, timelines, and vendor management with CROs/Strategic Partners.
• Provide SME input into protocols and study documents.
• Ensure studies meet timelines and regulatory requirements; onboarding of new team members.

Skills

Project management

Leadership

Communication

Teamwork

Problem-solving

Education

BS/BA in health-related or life sciences

Advanced degree(s) preferred

Job description

Takeda is seeking a Lead Clinical Study Manager to work remotely with the Clinical Operations Leadership team. You will guide study strategy, oversee execution, budgets, and vendor relationships for multiple programs, ensuring ICH GCP compliance and on-time delivery.

You will mentor junior CSMs, coordinate with partners and CROs, and ensure studies are inspection-ready. Travel 5–20% is expected to sites and international partners.