Senior Clinical Trial Manager
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Job Description
Clinical Trial Manager advancing Jade Biosciences’ autoimmune disease therapies through Phase 1–3 trials. Coordinating CROs, budgets, vendors, sites, compliance, and study execution.
Responsibilities:
- Support the Director, Clinical Operations, in planning and operational execution of assigned clinical trials
- Coordinate day-to-day study activities across cross-functional partners, clinical sites, CROs, and vendors
- Maintain study plans, timelines, budgets, risks, and key documentation
- Oversee vendor deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking
- Maintain clinical trial budgets and forecasts; review invoices, track spend, identify variances, and escalate financial risks
- Maintain risk, issue, decision, and action logs; drive mitigation and resolution activities
- Coordinate operational input into protocols, monitoring plans, informed consent forms, investigator brochures, manuals, and clinical study reports
- Oversee study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities
- Support investigator meetings and monitoring oversight
- Build relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders
- Review study performance metrics and implement corrective and preventive actions
- Ensure trial activities and documentation comply with protocols, Good Clinical Practice, regulations, contracts, and company procedures
- Coordinate operational requirements and timelines across clinical supply, laboratories, data management, safety, biostatistics, medical monitoring, and regulatory activities
- Maintain an accurate, inspection-ready Trial Master File and support audits, inspections, and quality oversight
- Mentor Clinical Trial Associates and Clinical Trial Managers, contribute to process improvements, and prepare study updates for governance and senior leadership
Requirements:
- Bachelor’s degree and 10+ years of related experience for Senior Clinical Trial Manager, or 7+ years of related experience for Clinical Trial Manager
- Trial management experience within a biopharmaceutical company
- Ability to manage complex clinical trial activities, timelines, vendors, budgets, risks, and cross-functional deliverables with appropriate independence and escalation
- Experience supporting Phase 1 through Phase 3 clinical trials
- Experience managing CROs and clinical vendors, including laboratories, RTSM, EDC, and ancillary clinical technology or applications
- Strong working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, medical terminology, and clinical trial conduct
- Working knowledge of clinical protocol implementation, regulatory submissions, Trial Master File requirements, and the overall drug development process
- Excellent communication, organization, collaboration, problem-solving, and attention-to-detail skills, with the ability to manage competing priorities
- Authorization to work in the United States verified through Form I-9 and E-Verify
Benefits:
- Remote work
- Periodic travel to team and company events
- Equal Opportunity employment
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