Clinical Project Manager, Biotech Vendor Oversight

Role: Clinical Project Manager focused on vendor management for a biotech developing gene therapies for inherited retinal diseases. Responsibilities: lead vendor qualification, onboarding, governance, performance oversight, and closeout; translate study needs into SOWs, manage budgets, invoices, and change orders; develop risk-based oversight plans; conduct vendor meetings and maintain inspection-ready documentation; escalate risks and contribute to SOP improvements. Requirements: Bachelor's in life or health sciences; 5+ years in clinical operations, project or vendor management; knowledge of ICH-GCP, FDA regulations, sponsor oversight; experience with KPIs, risk management, CAPA; strong organizational skills. Preferred: ophthalmology, gene therapy, rare disease experience; startup/biotech background. High-Value: ophthalmology, gene therapy, rare disease, clinical stage, vendor oversight, risk management, CRO coordination. WorkSetup: remote with hybrid options near Durham, NC; travel required for meetings and audits.