Clinical Study Manager

Role overview

The hiring company is looking for a Lead Clinical Study Manager to own the operational direction, planning, and delivery of clinical studies across assigned programs. The position is central to making sure global trials are executed to a high standard and remain aligned with the broader clinical development strategy.

Core responsibilities

• Take charge of operational planning and day-to-day execution for assigned clinical trials from initiation through final close-out.
• Contribute specialist operational guidance to protocol development, study plans, and connected study documents.
• Evaluate whether study plans are operationally practical, spot potential risks early, and recommend solutions that keep delivery on track.
• Manage study budgets, financial projections, and spending with external vendors.
• Support country and site selection efforts by providing operational insight that helps choose the best study locations.
• Make sure new team members, CROs, and vendor partners are effectively onboarded.
• Work with CROs and external partners to resolve issues quickly and preserve study progress.
• Lead vendor sourcing, contract discussions, and ongoing performance oversight.
• Monitor study activities, review key oversight materials, and track risks, emerging trends, and mitigation actions.
• Collaborate with data management to confirm database timeline expectations and keep them aligned with program goals.
• Maintain inspection-ready quality practices and assist with regulatory inspections when needed.
• Contribute to cross-functional initiatives and help onboard and mentor junior colleagues.
• Support program leadership with operational input as required.

Education and experience

A bachelor’s degree in a health-related, life science, or technology-related field is required, or an equivalent mix of education, training, and experience. Advanced degrees such as a master’s or doctorate may be accepted when paired with relevant training or experience, including fellowships or internships, to help satisfy experience expectations.

The role calls for at least 5 years of experience in the pharmaceutical industry and/or a clinical research organization, including 3+ years specifically in clinical study management or oversight. Relevant support experience such as clinical trial assistant, clinical trial associate, or lead CRA is also valued. Experience with early-phase studies, Phase 2/3 studies, and global or international programs is useful, and exposure to multiple therapeutic areas is considered an advantage.

Candidates should understand global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, ICH GCP, and local country rules. Strong results in project or program management, matrix leadership, communication, teamwork, organization, interpersonal effectiveness, and problem-solving are expected. Fluent business English in both spoken and written form is required.

Travel

This position involves about 5% to 20% travel, both domestically and internationally.