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.

• 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

• 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

• 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.