Clinical Trial Manager

Key Accountabilities / Core Job 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. 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. Contribute to data review, data cleaning activities, and operational review of study outputs and clinical documentation. Prepare and review study-related materials including training content, operational manuals, presentations, and status reports. Review study invoices, support accrual tracking, and monitor study spend against approved budgets. Qualifications/Skills Bachelor’s degree in life sciences, nursing, health sciences, or related field; advanced degree, RN, or PA preferred. 5+ years clinical research or pharmaceutical industry experience; 2+ years clinical trial management experience. Experience managing global/multi-site clinical studies (sponsor or CRO) preferred. Working knowledge of ICH/GCP, FDA regulations, and end-to-end clinical trial processes. Ability to manage multiple priorities, solve operational issues, and work 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. Benefits/Compensation Salary range: $139,000.00 to $180,000.00; competitive total rewards package including 401k, healthcare coverage, and ESPP. #J-18808-Ljbffr