Hybrid Clinical Project Manager - Gene Therapy Trials

Cpl Group; Greater London; Hybrid; GBP 70.000 - 95.000; Vollzeit

Zusammenfassung

Cpl Group is seeking an experienced Clinical Project Manager to lead planning, coordination and delivery of a gene therapy programme across phase II-III, working closely with Clinical Operations, Regulatory, CMC, Quality, Biometrics and external partners to ensure studies are on time and within budget.

This highly cross-functional role requires strong project management and clinical development knowledge, with responsibility for timelines, risks, dependencies, and executive reports to senior

Qualifikationen

• Experience in project management within biotechnology and clinical development environments.
• Experience supporting delivery of clinical-stage development projects.
• Strong understanding of clinical operations, regulatory activities, vendor management and study execution.
• Experience managing CROs and external service providers.
• Proven ability to manage complex timelines, budgets, risks and multiple stakeholders.
• Excellent communication and organisational skills with ability to influence across cross-functional teams.
• Strong attention to detail, problem-solving ability and delivery-focused approach.

Aufgaben

• Develop and maintain integrated clinical project plans with cross-functional teams.
• Lead cross-functional project meetings, track milestones, actions, risks and dependencies.
• Plan and execute global clinical studies ensuring start-up, enrolment, data delivery, regulatory activities and close-out.
• Oversee timelines, deliverables, performance, budgets and issue resolution with CROs and external providers.
• Coordinate regulatory submissions and health authority interactions with Regulatory Affairs.
• Work with CMC and supply to ensure clinical trial materials are available to support study timelines.
• Maintain project budgets, forecasts and resource plans; highlight risks and mitigation strategies.
• Prepare project reports, dashboards and updates for leadership with key decisions and priorities.
• Ensure project documentation and study records comply with procedures and regulatory requirements.
• Identify and manage project risks, escalating issues and driving solutions to minimise delivery impact.

Kenntnisse

Project management

Biotech experience

Clinical development

Vendor management

Cross-functional leadership

Budget management

Ausbildung

Degree in Life Sciences

PM certification desirable

Jobbeschreibung

Cpl Group is seeking an experienced Clinical Project Manager to lead planning, coordination and delivery of a gene therapy programme across phase II-III, working closely with Clinical Operations, Regulatory, CMC, Quality, Biometrics and external partners to ensure studies are on time and within budget.

This highly cross-functional role requires strong project management and clinical development knowledge, with responsibility for timelines, risks, dependencies, and executive reports to senior