Clinical Trial Manager, Clinical Operations

Duties and Responsibilities

• Manage day-to-day operational execution of assigned clinical studies to achieve study milestones, quality expectations, and budget objectives.
• May lead cross-functional study team activities and coordinate operational deliverables across internal stakeholders and external vendors.
• Oversee CROs and study vendors to ensure timely delivery, issue resolution, quality performance, and compliance with study requirements.
• Support study start-up activities, including feasibility assessments, country and site selection, vendor selection, system set-up, and user acceptance testing.
• Develop and maintain study management plans, operational timelines, and study tracking tools to support effective trial execution.
• Ensure inspection readiness and maintain Trial Master File documentation in compliance with ICH/GCP guidelines and company SOPs.
• Monitor study progress, identify operational risks, and implement mitigation plans to address issues impacting quality, timelines, or budget.
• Contribute to data review, data cleaning activities, and operational review of study outputs and clinical study documentation.
• Prepare and review study-related materials, including training content, operational manuals, presentations, and status reports.
• Review study invoices, support accrual tracking activities, and monitor study spend against approved budgets.

Requirements and Qualifications

• Typically requires a bachelor's degree in life sciences, nursing, health sciences, or a related field; advanced degree, RN, or PA credentials preferred.
• Typically requires 5+ years of clinical research or pharmaceutical industry experience, including 2+ years of clinical trial management experience.
• Experience managing global or multi-site clinical studies within a sponsor or CRO environment preferred.
• Working knowledge of ICH/GCP guidelines, FDA regulations, and clinical trial processes across study start-up, conduct, and closeout.
• Demonstrated ability to manage multiple priorities, solve operational issues, and drive projects independently in a fast-paced environment.
• Strong organizational, communication, and cross-functional collaboration skills.
• Proficiency with clinical trial systems, study tracking tools, and vendor management processes.