Sr. Clinical Trial Manager
K
Kyverna TherapeuticsBiopharmaceutical
West Coast RemoteFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- Budget management
Requirements
- B.S. degree.
- Minimum 5+ years of experience in clinical operations within biotech or pharmaceutical companies.
- Established Cell Therapy or CAR T study experience.
- Strong clinical study conduct experience from start-up through close-out.
- Working knowledge of relevant GCPs and FDA/EMA regulations.
- Knowledgeable of current ICH GCP guidelines and applicable regulations.
- Experience in small/mid biotechnology environment with a startup mindset.
- Strong leadership, effective decision making, and problem-solving skills.
- Ability to work effectively with minimal supervision and manage multi-task activities.
- Excellent written and verbal communication skills.
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, and service providers to ensure high quality and timely deliverables.
- Serve as the primary cross-functional operational contact for study teams including clinical operations, biostatistics, and regulatory.
- Ensure compliance with regulatory and quality standards such as FDA, EMA, and ICH-GCP.
- Oversee site feasibility, selection, contracting, and startup activities.
- Monitor study progress to identify risks and implement mitigation strategies for issues like enrollment delays or data quality.
- Ensure preparation for audits and maintain high standards of documentation readiness.
- Review invoices and track study budget according to the forecast.
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