The Clinical Trial Manager will oversee the operational execution of cell therapy trials, manage vendor relationships, and ensure compliance with study timelines and regulations.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
The Clinical Trial Manager (CTM) will support the operational execution of cell therapy clinical trials, with a primary focus on vendor management, including central laboratory oversight. This role is responsible for ensuring vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements.
This position requires strong vendor oversight capabilities and hands-on clinical operations experience, particularly in managing central labs and other external partners supporting complex cell therapy trials.
Title: Clinical Trial Manager
Location: Remote
Reports to: Executive Director, Clinical Operations
Responsibilities
- Serve as the primary contact for assigned vendors
- Participate in vendor selection activities (as needed)
- Develop and track study timelines, budgets, forecasts, and key performance indicators.
- Assist in day-to-day operational execution of assigned clinical trials from startup through close-out.
- Oversee site feasibility, selection, contracting, start‐up (site initiation visits, training, enrollment & retention strategies) and close‐out activities.
- Conduct Monitoring Oversight Visits (as needed)
- Support delivery of study milestones in alignment with program objectives.
- Lead vendor oversight through:
- Governance structures (e.g., recurring vendor meetings, KPIs, performance dashboards)
- Issue identification, escalation, and resolution
- Oversight of deliverables, timelines, and quality
- Ensure central lab operational readiness, including:
- Lab manual review and site training coordination
- Sample collection, processing, and shipment workflows
- Data transfer specifications and reconciliation with data management systems
- Partner closely with vendors to ensure timely, accurate data delivery.
- Review and approve vendor deliverables, invoices, and change orders; track spend vs. budget.
- Partner with cross-functional teams (Clinical Ops, Data Management, Biostatistics, Regulatory, Safety, Manufacturing, Supply Chain, Quality) to ensure aligned study execution.
- Communicate vendor performance and escalate risks/issues to leadership as needed.
- Identify and track risks related to vendor performance, lab data quality, logistics, and timelines.
- Collaborate cross-functionally to implement mitigation plans.
- Contribute to development/review of study documents (protocols, ICFs, CRFs, monitoring plans, lab manuals, data review plans).
- Support process improvements, particularly in vendor governance and central lab operations.
- Contribute to SOP development and best practices within Clinical Operations.
Qualifications
- B.S. degree with 4+ years of clinical operations experience in biotech or pharmaceutical industry.
- Strong vendor management experience required, including oversight of central laboratories.
- Strong understanding of managing clinical trials from startup through close-out.
- Exposure to cell therapy, CAR-T, or advanced biologics preferred.
- Working knowledge of ICH-GCP, FDA, and EMA regulations.
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities and work with moderate supervision.
- Experience in a biotech or startup environment preferred.
Top Skills
Cell Therapy
Ema Regulations
Fda
Ich-Gcp
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