Senior Clinical Project Manager – Rare Disease

Eblex Group; Greater London; Vor Ort; GBP 75.000 - 110.000; Vollzeit

Zusammenfassung

Eblex Group is seeking a Senior Clinical Project Manager to drive execution of its clinical development programmes within a lean biotech setting. This hands-on role collaborates with Clinical Operations, Medical, Regulatory, Quality and CRO partners to deliver trials on time, within budget and to quality standards.

The ideal candidate will bring 5+ years in clinical operations, strong ICH GCP knowledge and experience managing studies end-to-end, with preference for rare disease exposure.

Qualifikationen

• 5+ years experience in clinical operations or clinical study management within small biotech.
• Experience managing clinical studies across the study lifecycle.
• Rare disease experience is highly desirable.
• Strong understanding of ICH GCP and clinical trial requirements.

Aufgaben

• 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.

Kenntnisse

Clinical operations

Project management

Stakeholder management

Study management

ICH GCP knowledge

Jobbeschreibung

Eblex Group is seeking a Senior Clinical Project Manager to drive execution of its clinical development programmes within a lean biotech setting. This hands-on role collaborates with Clinical Operations, Medical, Regulatory, Quality and CRO partners to deliver trials on time, within budget and to quality standards.

The ideal candidate will bring 5+ years in clinical operations, strong ICH GCP knowledge and experience managing studies end-to-end, with preference for rare disease exposure.