Senior Clinical Trial Manager

Job Description

Position Summary

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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.

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Key Responsibilities

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• Manage day-to-day operational aspects of Phase I–III clinical trials from study start-up through closeout.
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• Develop and maintain study timelines, project plans, and trial tracking tools.
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• Coordinate activities among CROs, clinical sites, vendors, and internal stakeholders.
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• Monitor study progress and identify risks, implementing mitigation strategies as needed.
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• Review and execute according to essential study documents, including protocols, informed consent forms, monitoring plans, and study manuals.
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• Oversee CRO and site activation, enrollment, patient retention, and data collection activities.
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• Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
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• Have experience in managing study budgets, forecasts, and review of vendor contracts.
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• Lead study team meetings and provide regular updates to senior management.
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• Review monitoring reports, protocol deviations, and CAPA plans.
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• Support regulatory submissions, ethics committee approvals, and inspection readiness activities as needed.
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• Collaborate with Data Management, Biostatistics, Medical Monitoring, Safety, Regulatory Affairs, and Clinical Operations teams.
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• Contribute to process improvements and implementation of best practices across clinical programs.
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Qualifications

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• Bachelor's degree in the Sciences, Nursing, Pharmacy, Public Health, or related field.
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• Approximately 3-5 years of clinical research experience, including experience managing clinical studies.
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• Strong understanding of ICH-GCP guidelines and clinical trial regulations.
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• Experience working with CROs and external vendors.
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• Knowledge of CTMS, EDC, eTMF, and clinical trial systems.
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• Excellent project management, communication, and organizational skills.
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• Ability to manage multiple priorities in a fast-paced environment.
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Core Competencies

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• Clinical Trial Management
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• Project Planning & Execution
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• Risk Management
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• Vendor Oversight
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• Budget Management
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• Study Start-up & Closeout
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• Site Management
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• Regulatory Compliance
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• Cross-functional Leadership
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• Clinical Systems (CTMS, EDC, eTMF)
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Typical Therapeutic Area Experience

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• Oncology
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Expected Scope at 5 Years Experience

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• Independently manages 1–3 clinical studies or a significant portion of a large global study.
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• Provides oversight of CRO activities and site performance.
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• Escalates study risks appropriately and contributes to strategic study decisions.
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• May mentor Clinical Trial Associates (CTAs) or junior Clinical Research Associates (CRAs).
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