Clinical Biomarker Project Manager

Role:
Clinical Biomarker Project Manager

Location:

Welwyn Garden City, hybrid

Hours:

Full-time, 37.5 hours per week

Pay: £339.27 - £376.97 per day PAYE basic, excluding holiday pay, or £450 - £500 per day Umbrella

Contract:

6-month contract, inside IR35

An excellent opportunity has arisen for a Clinical Biomarker Project Manager to join one of our longstanding clients, a global pharmaceutical organisation, in Welwyn Garden City.

This is an excitin contract opportunity to support innovative clinical development programmes. You will take ownership of end-to-end biomarker operational strategy and execution, working across global study teams to ensure the successful delivery of biomarker and companion diagnostic activities.

Benefits

Hybrid working, with a minimum of two days per week in the Welwyn Garden City office
Opportunity to support global clinical development programmes
Exposure to innovative biomarker and companion diagnostic studies
Collaborative, cross-functional working environment
Competitive daily rates

The Requirements

Minimum of three years' experience within clinical research, clinical operations, diagnostics or pharmaceutical R&D
Degree in Life Sciences or a related scientific discipline, or equivalent industry experience
Strong clinical trial and operational project management experience
Experience managing external laboratories, vendors and service providers
Knowledge of biomarker operations, biosample management or companion diagnostics
Good understanding of ICH, GCP, ISO standards and clinical research regulations
Clinical or laboratory experience involving biological sample processing or analysis
Excellent communication, stakeholder management and presentation skills
Ability to work in a fast-paced, collaborative environment
Able to work from the Welwyn Garden City office for at least two days per week, with flexibility should office requirements change
Able to commit to a one-month notice period

The Role

Lead the operational planning and delivery of biomarker activities across one or more clinical development programmes
Develop and implement study-level biomarker operational strategies
Contribute to protocols, informed consent forms, Biomarker Management Plans and associated study documents
Manage central laboratories, specialist biomarker laboratories and external vendors
Oversee project scope, budgets, timelines, quality and performance
Coordinate biomarker data requirements and delivery timelines with scientific and clinical teams
Act as the main operational contact for biomarker and companion diagnostic activities across multiple studies
Provide technical knowledge relating to sample collection, handling, assays, devices and imaging technologies
Manage risks and ensure compliance with ICH, GCP, SOPs, ISO standards and regulatory requirements
Deliver presentations and training to internal and external stakeholders
Oversee testing-site monitoring activities and review associated reports
Maintain accurate and timely study data and documentation

The role is currently hybrid, with a minimum of two days per week in the office and home working available for the remainder. Candidates should understand that this guidance is fluid and office attendance requirements may change over time.

If you're keen to join an exceptional team offering the opportunity to contribute to the development of life-changing medicines, then please apply to this Clinical Biomarker Project Manager role below or call Chloe McCausland on (phone number removed) between 8:30am - 5:00pm