Clinical Project Manager, Biotech Vendor Oversight

Opus Genetics is a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases. The Clinical Project Manager, Vendor Management will oversee the sponsor-side clinical vendor ecosystem, including vendor qualification, contracting, governance, performance management, financial tracking, risk management, and inspection readiness across clinical studies.

Responsibilities:

• Lead vendor qualification, onboarding, governance, performance management, and closeout
• Translate study requirements into scopes of work, deliverables, and payment milestones
• Maintain budget tracking, invoice review, change order management, and financial forecasting
• Develop and manage vendor oversight plans using a risk-based approach
• Lead vendor kickoffs, governance meetings, and performance reviews
• Maintain inspection-ready documentation including meeting minutes, decisions, and CAPA tracking
• Identify and escalate quality, safety, regulatory, and timeline risks
• Contribute to SOPs, templates, and process improvements

Requirements:

• Bachelor's degree in life sciences, health sciences, or related discipline
• 5+ years in clinical operations, clinical project management, or CRO/vendor management
• Experience with clinical trial start-up, execution, and closeout
• Working knowledge of ICH-GCP, FDA clinical trial regulations, and sponsor oversight obligations
• Experience with KPIs, risk management, issue logs, and CAPA tracking
• Ability to review SOWs, budgets, invoices, and change orders
• Strong project management, communication, and organizational skills
• Ophthalmology, gene therapy, or rare disease clinical development experience
• Small biotech or startup environment experience