Kyverna - Clinical Trial Manager
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Requirements
• 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.
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.
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