Clinical Project Manager

Barrington James; England; Presencial; GBP 55.000 - 85.000; Jornada completa

Descripción de la vacante

Barrington James is seeking an experienced Clinical Project Manager to lead operational delivery of clinical trials in a growing biopharmaceutical environment. You will manage studies from startup through closeout, coordinating with internal teams, CROs, sites and external vendors to ensure delivery within time, budget and quality expectations.

The role requires 5+ years in trial management, with experience in biotech/pharma settings and knowledge of ICH-GCP.

Formación

• Five plus years in clinical trial management.
• Experience leading studies from start-up to closeout.
• Biotech or pharmaceutical environment background.
• Experience with Phase I–III trials.
• Strong CRO, vendor and site management experience.
• Knowledge of ICH-GCP and clinical regulations.
• Experience in UK/EU/US trial landscape.
• Knowledge of eTMF systems; Veeva Vault is a plus.
• Data privacy and GDPR awareness.

Responsabilidades

• Lead day-to-day management of clinical trials from start-up to closeout.
• Oversee site identification, feasibility, contracting, budgeting and activation.
• Manage CROs, service providers and external vendors.
• Monitor study budgets, timelines and milestones.
• Develop and maintain project plans and critical path activities.
• Lead cross-functional study team meetings and drive actions.
• Manage site and study team communications.
• Oversee TMF setup and inspection readiness.
• Identify risks and implement mitigation strategies.
• Support CAPAs, audits and inspections.
• Contribute to study documentation (protocols, IBs, ICFs).
• Review trial data and procedures for quality.
• Build relationships with investigators, CROs and stakeholders.
• Escalate significant issues to Clinical Operations leadership.
• Contribute to SOPs and quality processes.
• Provide line management support to Trial Managers/Administrators.

Conocimientos

Clinical trial Mgmt

Start-up to closeout

Veeva Vault

ICH-GCP

Vendor management

Cross-functional team

Educación

Bachelor’s degree in Biological Sciences or related field

Descripción del empleo

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 within 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