Note: The job is a remote job and is open to candidates in USA. Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Sr. Clinical Trial Manager will lead the operational delivery of one or more cell therapy clinical trials from study design through close-out, ensuring compliance with regulatory standards and managing cross-functional coordination.
Responsibilities
- Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out
- Develop and manage study timelines, budgets, forecasts, and related operational metrics
- Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables
- Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality)
- Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs
- Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation
- Oversee site feasibility, selection, contracting, start‐up (site initiation visits, training, enrollment & retention strategies) and close‐out activities
- Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies
- Foster effective communication across study teams, escalate issues to senior leadership as needed
- Ensure preparation for audits/inspections, maintain high standards of documentation readiness
- Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training)
- Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations
- Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed
- Vendor Management – Contribute to or lead cross-program vendor management activities
- Contribute to SOP development within the Clinical Operations team
Skills
- B.S. degree with minimum 5+ years of experience in clinical operations including managing clinical trials in biotech, pharmaceutical
- Strong clinical study conduct experience from start-up through close-out
- Strong leadership, effective decision making, and problem-solving skills required
- Established Cell Therapy /CAR T study experience required
- Working knowledge of relevant GCPs and FDA/EMA regulations
- Knowledgeable of current ICH GCP guidelines and applicable regulations
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
- Experience in small/mid biotechnology environment (startup mindset)
- Excellent written and verbal communication skills
Benefits
- Eligible for bonus
- Benefits
- Participation in the company’s stock plan
Company Overview
Company H1B Sponsorship