Senior Clinical Trial Manager

Position Summary

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
• Risk Management
• Vendor Oversight
• 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).