Senior Clinical Trial Manager

A Clinical Trial Manager with 3-8 years of experience in the planning, execution, oversight, and delivery of clinical trials in accordance with protocol requirements, ICH-GCP guidelines, applicable regulations, and company SOPs. Manages study timelines, vendors, budgets, and cross-functional teams to ensure high-quality trial conduct and successful study outcomes. Key Responsibilities Manage day-to-day operational aspects of Phase I–III clinical trials from study start-up through closeout. Develop and maintain study timelines, project plans, and trial tracking tools. Coordinate activities among CROs, clinical sites, vendors, and internal stakeholders. Monitor study progress and identify risks, implementing mitigation strategies as needed. Review and execute according to essential study documents, including protocols, informed consent forms, monitoring plans, and study manuals. Oversee CRO and site activation, enrollment, patient retention, and data collection activities. Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Have experience in managing study budgets, forecasts, and review of vendor contracts. Lead study team meetings and provide regular updates to senior management. Review monitoring reports, protocol deviations, and CAPA plans. Support regulatory submissions, ethics committee approvals, and inspection readiness activities as needed. Collaborate with Data Management, Biostatistics, Medical Monitoring, Safety, Regulatory Affairs, and Clinical Operations teams. Contribute to process improvements and implementation of best practices across clinical programs. Qualifications Bachelor's degree in the Sciences, Nursing, Pharmacy, Public Health, or related field. Approximately 3-5 years of clinical research experience, including experience managing clinical studies. Strong understanding of ICH-GCP guidelines and clinical trial regulations. Experience working with CROs and external vendors. Knowledge of CTMS, EDC, eTMF, and clinical trial systems. Excellent project management, communication, and organizational skills. Ability to manage multiple priorities in a fast-paced environment. Core Competencies Clinical Trial Management Project Planning & Execution Budget Management Study Start-up & Closeout Site Management Regulatory Compliance Cross-functional Leadership Clinical Systems (CTMS, EDC, eTMF) Typical Therapeutic Area Experience Oncology Expected Scope at 5 Years Experience Independently manages 1–3 clinical studies or a significant portion of a large global study. Provides oversight of CRO activities and site performance. Escalates study risks appropriately and contributes to strategic study decisions. May mentor Clinical Trial Associates (CTAs) or junior Clinical Research Associates (CRAs). #J-18808-Ljbffr