Clinical Trial Manager

Key Responsibilities:

• Serve as primary contact for assigned vendors and participate in vendor selection activities, overseeing governance structures, issue resolution, and deliverable quality.
• Develop and track study timelines, budgets, forecasts, and key performance indicators while reviewing and approving vendor invoices and change orders.
• Ensure central lab operational readiness, including lab manual review, sample workflow coordination, and data transfer specifications.

Cross-functional Collaboration:

• Partner closely with vendors to ensure timely, accurate data delivery and with internal teams (Clinical Ops, Data Management, Regulatory, Safety, Manufacturing) for aligned study execution.
• Communicate vendor performance and escalate risks or issues to leadership as needed, identifying and tracking risks related to vendor performance and lab data quality.
• Collaborate to implement mitigation plans and contribute to process improvements in vendor governance and central lab operations.

Qualifications and Requirements:

• B.S. degree with 4+ years of clinical operations experience in biotech or pharmaceutical industry and strong vendor management experience, including central laboratory oversight.
• Strong understanding of managing clinical trials from startup through close-out, with exposure to cell therapy, CAR-T, or advanced biologics preferred.
• Working knowledge of ICH-GCP, FDA, and EMA regulations, along with strong organizational, communication, and problem-solving skills to manage multiple priorities.