Clinical Study Manager

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.

• 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

• 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

Clinical Operations | Clin Ops | Biotech | Rare Disease | Clinical | Clinical Study Manager | Global | Early Phase | Late Phase | Clinical Development | CPM | CSM | CTM