Clinical Project Manager, Biotech Vendor Oversight

Clinical Project Manager, Vendor Management
Department: Clinical Development | Location: Remote (Hybrid available for Durham, NC area).
Travel required. Role is currently remote with hybrid options for those close to the home office in Durham, North Carolina. Occasional travel may be required for company meetings, investigator or vendor meetings, audits, study activities, and other business needs.
About Opus Genetics
Opus Genetics is a clinical-stage biotechnology company developing transformational gene therapies for patients with inherited retinal diseases. We are advancing a growing clinical portfolio and building the operational infrastructure to match.
The Opportunity
We are looking for a Clinical Project Manager, Vendor Management to own the sponsor side of our clinical vendor ecosystem. This is a hands-on operational role responsible for planning, contracting, overseeing, and managing the performance of CROs and specialty clinical vendors across our studies.
You will serve as the central point of accountability for vendor qualification, governance, financial tracking, risk management, and inspection readiness - working across outsourced, hybrid, and in-sourced operating models.
What You'll Do
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
What We're Looking For
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
Preferred
Ophthalmology, gene therapy, or rare disease clinical development experience
Small biotech or startup environment experience
Why Opus?
A remote-friendly role with direct impact on a growing clinical portfolio. Competitive compensation, equity, and the opportunity to help build the operational foundation of a mission-driven biotech.

Work arrangement
Yes