Clinical Trial Manager

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.

Qualifications

• 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.