Senior Clinical Project Manager: Lead - Closeout

An exciting opportunity is available for an experienced Clinical Project Manager to join an innovative and growing biopharmaceutical organisation supporting the delivery of clinical development programmes.

This is a broad clinical operations role with responsibility for managing studies from start-up through to closeout, working closely with internal cross-functional teams, CROs, clinical sites and external vendors.

The Role

You will be responsible for the operational delivery of assigned clinical trials, ensuring studies are delivered to time, budget and quality expectations and in accordance with ICH-GCP and applicable regulations.

Key responsibilities will include:

• Leading the day-to-day management of clinical trials from study start-up through closeout

• Supporting site identification, feasibility, selection, contracting, budgeting and activation

• Managing CROs, service providers and external vendors

• Overseeing study budgets, timelines and key milestones

• Developing and maintaining project plans and critical path activities

• Leading cross-functional study team meetings and ensuring actions are followed through

• Managing site and study team communications

• Overseeing TMF set-up and maintenance and ensuring inspection readiness

• Identifying and managing study risks and implementing mitigation strategies

• Supporting CAPAs, audits and inspections

• Contributing to study documentation including protocols, IBs and ICFs

• Reviewing trial data and procedures to ensure quality

• Building strong relationships with investigators, KOLs, CROs and external stakeholders

• Escalating significant operational, quality or timeline issues to Clinical Operations leadership

• Supporting the development and review of SOPs and clinical quality processes

• Providing some line management support to Clinical Trial Managers and/or Clinical Trial Administrators

About You

The ideal candidate will have:

• 5+ years' experience in clinical trial management

• Strong experience managing studies from start-up through to closeout

• Experience with in a biotech or pharmaceutical environment

• Experience managing Phase I–III clinical trials

• Strong CRO, vendor and clinical site management experience

• A strong understanding of ICH-GCP and clinical research regulations

• Experience working across the UK, EU and/or US clinical trial environment

• Experience with eTMF systems; Veeva Vault experience would be advantageous

• Good understanding of data privacy and GDPR requirements

• Experience in advanced therapies, ATMPs or First-in-Human studies would be advantageous

• A degree in Biological Sciences or a related discipline, or equivalent experience