Clinical Study Manager

Job Title : Lead Clinical Study Manager

Location : Remote - United States

Type : Full time

Our Client is seeking a Lead Clinical Study Manager to drive the operational strategy, planning, and execution of clinical studies across assigned programs. This role plays a pivotal part in ensuring high‑quality delivery of global clinical trials while aligning study execution with the overall clinical development plan.

Key Responsibilities

• Lead the operational planning and execution of assigned clinical trials from start‑up to close‑out.
• Provide expert operational input into protocol design, study plans, and related documentation.
• Assess operational feasibility, proactively identifying risks and solutions to optimize study delivery.
• Oversee study budgets, financial forecasting, and external vendor spend.
• Participate in country and site selection activities, bringing insights to ensure optimal study placement.
• Ensure effective onboarding of team members, CROs, and vendor partners.
• Guide CROs and external partners to resolve issues promptly and maintain study momentum.
• Drive vendor selection, contract discussions, and ongoing performance management.
• Oversee monitoring activities, review critical oversight documents, and track study risks, trends, and mitigation steps.
• Partner with data management to validate database activity timelines and ensure alignment with program objectives.
• Maintain inspection‑ready quality standards and support regulatory inspections when needed.
• Contribute to cross‑functional initiatives and support onboarding/mentorship of junior team members.
• Provide operational support to program leadership as required.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related field (advanced degrees preferred).
• 6+ years’ experience in the pharmaceutical or clinical research industry, with at least 4+ years managing clinical trials.
• Background in early‑phase or late‑phase global studies; experience across multiple therapeutic areas is a plus.
• Strong knowledge of global regulatory and GCP requirements.
• Proven project management, cross‑functional leadership, and vendor oversight experience.
• Excellent communication, organizational, and problem‑solving skills.
• Proficiency in written and spoken English.

Travel Requirement

• Approximately 5–20% international and domestic travel.