Remote Lead Clinical Study Manager: Strategy & Execution

Takeda; Northern (KY); Hybrid; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager (LeadCSM) for remote work in the United States (Massachusetts virtual). You will lead cross-functional study execution, oversee budgets, and manage strategic partners/CROs to ensure on-time delivery of clinical programs.

The role requires 6+ years in pharma/CRO with 4+ years in study management, strong leadership, and fluency in business English. Travel 5–20% and collaboration with global teams are expected.

Qualifications

• BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent.
• 6+ years’ experience in pharmaceutical industry and/or CRO, including 4+ years in clinical study management/oversight.
• Experience in early phase and/or Phase 2/3 global studies across therapeutic areas.
• Advanced degree(s) may supplement experience.
• Knowledge of global regulatory requirements (US CFR, EU CTR, ICH GCP).
• Strong project/program management and matrix leadership.
• Good communication skills.
• Fluent business English (oral and written).
• Travel approx. 5–20% to other Takeda sites and partners.

Responsibilities

• Lead cross-functional study execution team to meet objectives in compliance with ICH GCP and Takeda SOPs.
• Oversee CROs and 3rd party vendors to meet study obligations.
• Collaborate with other study management colleagues as needed.
• Plan and execute operational strategy for assigned trials.
• Provide input into protocol synopsis and related documents.
• Ensure timelines align with the clinical development plan and budget.
• Onboard new team members and vendors.
• Develop operational strategy with strategic partners/CROs during early engagement.
• Mentor and support study management team members.

Skills

Communication

Teamwork

Problem-solving

Business English

Leadership

Education

BS/BA life sciences

Advanced degree preferred

Job description

Takeda is seeking a Lead Clinical Study Manager (LeadCSM) for remote work in the United States (Massachusetts virtual). You will lead cross-functional study execution, oversee budgets, and manage strategic partners/CROs to ensure on-time delivery of clinical programs.

The role requires 6+ years in pharma/CRO with 4+ years in study management, strong leadership, and fluency in business English. Travel 5–20% and collaboration with global teams are expected.