Clinical Trials Manager

Somerset NHS Foundation Trust is seeking an experienced and highly capable Clinical Trials Manager to lead the management and delivery of our Trust-sponsored and investigator-led clinical trials portfolio.

This is a senior operational role with responsibility for the end-to-end management of sponsored studies, including both CTIMPs and non-CTIMPs, across a range of clinical specialties and research themes.

The postholder will provide expert leadership across the full trial lifecycle -- from protocol development and grant applications, through regulatory approvals, study set-up, delivery, monitoring and close-out -- working in close partnership with Chief Investigators and the wider R&D leadership team.

You will play a central role in strengthening the Trust's capacity as a research sponsor, ensuring that studies are delivered to the highest standards of Good Clinical Practice (GCP), regulatory compliance and scientific quality.

About the Department of Clinical Research.

The Department of Clinical Research (DoCR) supports and enables high-quality research across Somerset NHS Foundation Trust, ensuring that patients have access to innovative studies and that all research activity meets national regulatory and ethical standards.

We provide governance, infrastructure and expert support for both hosted and Trust-sponsored research and are committed to building a strong culture of research excellence, quality and continuous improvement across the organisation.

As Clinical Trials Manager, you will:

• Lead the operational delivery of Trust sponsored clinical trials from design to closeout
• Work with Chief Investigators to develop protocols, study documentation, and funding applications
• Coordinate regulatory submissions (MHRA, HRA, REC) and oversee multicentre site setup, monitoring, and closure
• Maintain oversight of Trial Master Files and ensure the portfolio is inspection ready
• Monitor progress against timelines, budgets, recruitment targets, and quality standards
• Supervise and support trial coordinators, data managers, and monitoring staff
• Ensure all study activities comply with GCP, UK Clinical Trials Regulations, and sponsor SOPs
• Act as a key contact for audits, inspections, funders, and external collaborators
• Contribute to strengthening research infrastructure and trial management capacity across the Trust

We're looking for someone who has:

• Significant experience managing clinical trials (CTIMPs and/or nonCTIMPs), including multicentre delivery
• Strong knowledge of UK Clinical Trials Regulations, ICHGCP, and research governance
• Experience supporting protocol development, approvals, funding applications, and trial oversight
• Proven ability to manage complex workloads, deadlines, and competing priorities
• Strong communication and interpersonal skills, able to work effectively with investigators, research teams, and external partners

At Somerset NHS Foundation Trust, we're committed to supporting our employees with a range of benefits designed to enhance your professional and personal life. We offer:

Flexible working options to help you balance work and life

NHS pension scheme for long-term financial security

Generous annual leave allowance to recharge and relax

A strong focus on career development to help you grow and achieve your potential

Additionally, you'll gain access to our Blue Light Card, unlocking exclusive discounts on shopping, dining, and leisure activities, as well as NHS-specific perks to support you both inside and outside of work.

We are proud to foster a diverse, skilled, and inclusive workforce, and we encourage applications from all backgrounds.

Why Somerset? Somerset offers the perfect blend of idyllic countryside, outstanding areas of natural beauty, and breathtaking coastlines, with vibrant cities like Bristol, Bath, and Exeter just a short drive away - and only two hours to London.

The region is home to excellent educational facilities, and with affordable housing compared to other parts of the country, it's a great place to build both your career and your future.

Somerset truly has it all - the peaceful countryside and cosmopolitan city life, with something for everyone to enjoy.

The Clinical Trials Manager will be responsible for the effective management and delivery of the Trust's portfolio of Trust-sponsored and investigator-led clinical trials, spanning a range of specialties and including both CTIMPs and non-CTIMPs. These may be single or multi-centre studies, conducted at local, regional, national, and global levels.

The postholder will provide expert leadership and operational oversight across the full life cycle of sponsored studies, from concept and grant application through set-up, delivery, monitoring, and close-out. They will work in close partnership with Chief Investigators (CIs) to develop protocols, secure approvals, establish systems and processes, and ensure that all studies are delivered to the highest standards of Good Clinical Practice (GCP), UK Clinical…