Clinical Lead II - Rare Disease / Oncology

Premier Research • Regional_NC, NC

9d

About The Position

Premier Research is seeking a Clinical Lead II for its Clinical Management team, focused on rare disease and oncology. The role supports biotech, medtech, and specialty pharma companies in developing medicines, devices, and diagnostics that can improve and save lives. The Clinical Lead serves as the initial contact for site management and monitoring quality concerns, oversees clinical monitoring and site management deliverables, and supports audit readiness and resolution of findings. The position also represents Clinical and SSU functions in sponsor calls and monitors clinical operations performance, timelines, and metrics.

Requirements

• Bachelor’s degree, or international equivalent, from an accredited institution in a clinical, biological, scientific, or health-related field, or equivalent work experience.
• At least 2 years of experience as a Clinical Lead, ideally on global studies, gained in a CRO setting.
• Prior onsite monitoring experience.
• Prior experience in both rare diseases and oncology.
• Working knowledge of clinical financials, including budgets, pass-through costs, and resource management.

Nice To Haves

• Risk-Based Monitoring experience.
• Experience as a Clinical Lead managing trials in rare diseases and oncology, rather than experience solely in a CRA capacity.
• Biliary liver disease therapeutic experience.
• Oncology experience in CAR-T and/or cell and gene therapy.
• Experience working on pediatric trials.

Responsibilities

• Serve as the initial point of contact for site management and monitoring quality concerns, including initiating and overseeing site performance improvement plans (sPIPs).
• Plan, present, and participate in sponsor calls, representing Clinical and SSU functions and providing status updates on clinical deliverables.
• Oversee the quality of clinical monitoring, central monitoring, and site management deliverables using dashboards and reporting tools; contribute strongly to the central monitoring plan.
• Regularly monitor clinical operations metrics, activities, and timelines.
• Track data entry timelines, open actions, protocol deviations, query aging reports, SDR/SDV backlog, and monitoring visit report turnaround timelines.
• Ensure audit readiness for Premier and study sites.
• Review and respond to audit findings and support sites with remediation and responses to site audit findings.
• Escalate CRA, CM, and SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct, and other events requiring prompt assessment and reporting through established channels.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level