Support the operational execution of cell therapy clinical trials with a primary focus on vendor management, including central laboratory oversight.
Ensure vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements.
Oversee site feasibility, selection, contracting, start-up and close-out activities.
Conduct Monitoring Oversight Visits as needed.
Lead vendor oversight through governance structures, issue identification, escalation, and resolution.
Ensure central lab operational readiness, including lab manual review and site training coordination.
Partner closely with vendors to ensure timely, accurate data delivery.
Communicate vendor performance and escalate risks/issues to leadership as needed.
Contribute to development/review of study documents and support process improvements in vendor governance and central lab operations.

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.

Clinical Trial Manager

Key skills