Eblex Group is supporting a growing rare disease biotechnology company in the search for a Clinical Study Manager to support the delivery of its clinical development programmes.
This is a hands on study management role within a lean biotech environment, working closely with Clinical Operations, Clinical Development, Medical, Regulatory, Quality and external CRO partners to ensure studies are delivered to the required timelines, budget and quality standards.
Key Responsibilities of the Clinical Study Manager
- Manage assigned clinical studies from study planning through to closeout
- Support protocol development, study feasibility and operational planning
- Develop and maintain study timelines, trackers, budgets and operational plans
- Coordinate CROs, vendors and other external partners supporting study delivery
- Support country and site feasibility, selection and activation
- Monitor recruitment, study milestones, risks and operational performance
- Work with sites and investigators to address study issues and maintain delivery
- Ensure clinical trial activities are conducted in accordance with ICH GCP, applicable regulations, protocol and SOPs
- Maintain oversight of study documentation and TMF quality and completeness
- Support study meetings, governance activities and reporting to senior stakeholders
- Contribute to inspection readiness and study closeout activities
What We're Looking For in the Clinical Study Manager
- 5+ years' experience in clinical operations or clinical study management within small biotech
- Experience managing clinical studies across the study lifecycle
- Previous rare disease experience highly desirable
- Strong understanding of ICH GCP and clinical trial requirements
- Experience working with CROs, investigators and external vendors
- Strong organisational and project management skills
- Comfortable working independently within a small, fast moving biotech environment
- Strong communication and stakeholder management skills
Eblex Group is managing this search exclusively.
Apply directly or contact Eblex Group for a confidential discussion.
Clinical Operations | Clin Ops | Biotech | Rare Disease | Clinical | Clinical Study Manager | Global | Early Phase | Late Phase | Clinical Development | CPM | CSM | CTM
