Senior Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist the Director of Clinical Operations in the planning and execution of assigned clinical trials.

• Facilitate daily study activities among cross-functional teams, clinical sites, CROs, and vendors.

• Manage study plans, timelines, budgets, risks, and essential documentation.

• Supervise vendor deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking.

• Oversee clinical trial budgets and forecasts; evaluate invoices, monitor expenditures, identify discrepancies, and escalate financial risks.

• Maintain logs for risks, issues, decisions, and actions; lead mitigation and resolution efforts.

• Coordinate operational contributions to protocols, monitoring plans, informed consent documents, investigator brochures, manuals, and clinical study reports.

• Manage activities related to study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection readiness.

• Assist in investigator meetings and monitoring oversight.

• Cultivate relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders.

• Analyze study performance metrics and implement corrective and preventive measures.

• Ensure that trial activities and documentation adhere to protocols, Good Clinical Practice, regulations, contracts, and company procedures.

• Coordinate operational needs and timelines across clinical supply, laboratories, data management, safety, biostatistics, medical monitoring, and regulatory functions.

• Maintain a precise, inspection-ready Trial Master File and support audits, inspections, and quality oversight.

• Mentor Clinical Trial Associates and Clinical Trial Managers, contribute to process enhancements, and prepare study updates for governance and senior leadership.

⛳️ Requirements

• Bachelor’s degree with 10+ years of relevant experience for Senior Clinical Trial Manager, or 7+ years for Clinical Trial Manager.

• Experience in trial management within a biopharmaceutical organization.

• Capability to manage intricate clinical trial activities, timelines, vendors, budgets, risks, and cross-functional deliverables with appropriate independence and escalation.

• Familiarity with supporting Phase 1 through Phase 3 clinical trials.

• Experience overseeing CROs and clinical vendors, including laboratories, RTSM, EDC, and ancillary clinical technologies or applications.

• Strong knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, medical terminology, and clinical trial execution.

• Understanding of clinical protocol implementation, regulatory submissions, Trial Master File requirements, and the overall drug development process.

• Exceptional communication, organization, collaboration, problem-solving, and attention-to-detail abilities, with the capacity to manage competing priorities.

• Authorization to work in the United States verified through Form I-9 and E-Verify.

🏝️ Benefits

• Remote work options available.

• Occasional travel for team and company events.

• Commitment to Equal Opportunity employment.