An exciting opportunity has arisen for an experienced Clinical Project Manager to join an ambitious, early-stage gene therapy biotech as it builds its clinical operations function.
Working within a lean, growing team, you’ll take hands‑on ownership of clinical studies from set‑up through to close‑out, with the opportunity to shape how clinical operations develops as the business and its pipeline expand.
The role
- Lead the selection, onboarding and management of CROs and specialist vendors, including RFPs, bid defence and contract input.
- Take ownership of assigned clinical trials from set‑up through to close‑out, ensuring delivery against timelines, budgets and quality expectations.
- Oversee study plans, regulatory and ethics submissions, essential documentation and trial milestones.
- Manage CRO performance and site delivery, working closely with investigators and external partners to maintain study quality.
- Coordinate study activities across clinical operations, including site readiness, supplies, data cleaning and close‑out deliverables.
- Monitor budgets, forecasts, change orders and invoices, escalating risks and issues promptly.
- Contribute to the development of clinical SOPs, processes, templates and vendor governance as the function evolves.
We’re looking for:
- At least five years’ experience in clinical operations, with direct responsibility for live interventional trials.
- Experience selecting and managing CROs or clinical vendors, including RFPs and bid defence.
- Strong project management, organisational and stakeholder management skills.
- The confidence to work independently, make decisions within your remit and escalated issues when needed.
- A proactive, hands‑on approach and a willingness to contribute beyond your immediate responsibilities.
- Excellent written and verbal communication skills.
Experience in any of the following would be particularly valuable:
- Gene therapy or other complex biologics.
- CNS or neurosurgical trials.
- Drug‑device combination products.
- Surgical or late‑phase interventional studies.