Clinical Study Manager

The Contract Clinical Study Manager is responsible for providing operational leadership, coordination, and oversight of assigned clinical studies from study start-up through close-out. This role works collaboratively with internal cross‑functional teams, contract research organizations (CROs), vendors, investigators, and site personnel to ensure studies are executed efficiently, compliantly, and in alignment with clinical development objectives.

The ideal candidate is a proactive clinical operations professional with strong expertise in study management, vendor oversight, risk management, and cross‑functional collaboration. The Clinical Study Manager will ensure study activities are conducted in accordance with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and project timelines while maintaining a strong focus on quality, compliance, and inspection readiness.

• Lead and oversee day‑to‑day operational activities for assigned clinical studies from initiation through close‑out.
• Coordinate study execution with internal stakeholders, CROs, vendors, investigators, and site personnel to ensure achievement of study milestones and deliverables.
• Monitor study start‑up activities, including essential document collection, site activation requirements, investigational product readiness, and study‑specific tracking processes.
• Facilitate and lead study team, vendor, and CRO meetings to review study progress, identify risks, track action items, and drive issue resolution.
• Develop, maintain, and monitor study timelines, deliverables, and risk mitigation plans to support successful study execution.
• Support vendor selection and contracting activities, including requests for proposal (RFPs), scope of work development, budget review, and vendor planning documentation.
• Oversee CRO and vendor performance, ensuring timely delivery of study services and proactive management of operational challenges.
• Identify, escalate, and support resolution of study risks, quality concerns, and performance issues through appropriate corrective and preventive action (CAPA) plans.
• Coordinate and document study‑specific training for CRO personnel, vendors, investigators, site staff, and internal study team members.
• Monitor vendor staff qualifications, training compliance, personnel changes, and performance against key study milestones and performance indicators.
• Support Trial Master File (TMF) management activities, including document filing, reconciliation, quality control reviews, and inspection readiness initiatives.
• Draft, review, and approve study‑related documentation, including informed consent forms, study manuals, monitoring plans, site tools, pharmacy manuals, laboratory manuals, and monitoring reports, as applicable.
• Review monitoring findings, audit observations, and other study conduct issues, ensuring appropriate follow‑up and resolution.
• Serve as a key operational contact for clinical sites, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating complex issues as needed.
• Ensure study records and processes are maintained in compliance with regulatory requirements, company procedures, and study‑specific plans.
• Oversee CTMS maintenance, study metrics, and status reporting to support effective management of study progress and performance.
• Review clinical data, monitoring trends, vendor outputs, and study reports to support data quality, integrity, and GCP compliance.
• Collaborate with Data Management, Biostatistics, Safety, Regulatory Affairs, Clinical Supply, Contracts, and other functional groups to ensure coordinated study execution.
• Provide input into case report form design, data management plans, data transfer specifications, and clinical data review activities.
• Prepare regular study status updates, risk assessments, operational reports, and executive summaries for internal stakeholders.
• Contribute to study, site, and vendor budget planning, forecasting, and financial oversight activities.
• Review site and vendor invoices to ensure expenses align with approved budgets, contracted services, and study agreements.
• Support development of investigator budget templates, vendor…