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.