Role: Clinical Trial Expert

Location: Welwyn (Hybrid - 3 days in office)

Hours: Monday - Friday

Pay: £301.57 - £339.57 per day (PAYE) OR £400.00 - £450.00 per day (UMB)

Start Date: May

12 Month Contract Inside of IR35

An excellent opportunity has arisen for a Clinical Trial Expert to join one of our longstanding clients, an exciting global client in Welwyn.

Benefits:

• Hybrid (3 days in office), providing flexibility when able
• Weekly competitive pay.
• Free parking onsite
• 25 days holiday per annum + recognised bank holidays
• Opportunity to work in a dynamic and diverse organisation.
• Exposure to cutting-edge clinical trial innovations.
• Professional growth and development opportunities.

The Requirements:

• Strong experience in Clinical Trial Management (Phase 1 Health Volunteer studies preferred).
• Background in Pharma, Biotech, or Contract Research Organisations (CROs).
• Expertise in study close-out processes and regulatory compliance.
• Experience in pharmaceutical or healthcare industries with knowledge of drug development processes.
• University degree (Life Sciences preferred) or equivalent experience.
• Strong background in clinical trial execution, including understanding of ICH-GCP and regulatory requirements.
• Expertise in clinical trial management tools, such as IxRS, eCOA, and digital biomarkers.
• Strong leadership, collaboration, and problem-solving skills.
• Ability to navigate fast-paced and ambiguous environments while maintaining attention to detail.
• Experience in project management and process improvement methodologies.
• Willingness to travel internationally as required.

The Role:

As a Clinical Trial Expert, you will be responsible for executing clinical trials across all phases, ensuring operational excellence, and driving productivity. Key responsibilities include:

• Oversee Clinical Pharmacology & Health Volunteer studies, ensuring smooth execution.
• Support study close-out activities while ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to drive study execution.
• Ensure adherence to Good Clinical Practice (GCP) and regulatory standards.
• Support trial execution strategies and contribute to study design.
• Establish and maintain relationships with internal and external stakeholders.
• Ensure compliance with regulatory requirements and participate in audits and inspection readiness.
• Manage systems and tools essential for trial operations, including IxRS, eCOA, and digital biomarkers.
• Coordinate study start-up components, such as imaging and investigator training.
• Develop and maintain trial oversight documentation (e.g., risk management plans, monitoring plans).
• Track study progress and collaborate with teams to resolve challenges.
• Drive efficiency across clinical operations by standardising processes and supporting portfolio-wide initiatives.

If you're keen to join an exceptional team who can offer an excellent working environment and opportunities, then please apply to this Clinical Trial Expert role below or call Chloe McCausland on between 9:00am and 5:00pm.