Job summary
About the role.
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.
Main duties of the job
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
About us
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.
Job description
Job responsibilities
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 Trials Regulations, and sponsor requirements.
The role will also carry line management responsibility for a team of trial management staff and will contribute to the growth of research capacity and infrastructure within the Trust.
Why join Somerset NHS FT?
- Work within a supportive, expanding research department at a Trust committed to innovation and high quality research
- Play a central role in growing a Trust-sponsored trials portfolio
- Influence how trials are designed, delivered and supported across the Trust
- Real opportunity to shape infrastructure, systems and ways of working
- Be part of a collaborative, motivated team advancing research that directly benefits patients across Somerset
For an informal discussion about the role, please contact: Flo Cullen, flo.cullen@somersetft.nhs.uk 01823 342582
Please refer to the attached job description for further details on the role. When completing your application please make sure to tell us how your experience and skills fit the person specification.
Job description
Job responsibilities
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 Trials Regulations, and sponsor requirements.
The role will also carry line management responsibility for a team of trial management staff and will contribute to the growth of research capacity and infrastructure within the Trust.
Why join Somerset NHS FT?
- Work within a supportive, expanding research department at a Trust committed to innovation and high quality research
- Play a central role in growing a Trust-sponsored trials portfolio
- Influence how trials are designed, delivered and supported across the Trust
- Real opportunity to shape infrastructure, systems and ways of working
- Be part of a collaborative, motivated team advancing research that directly benefits patients across Somerset
For an informal discussion about the role, please contact: Flo Cullen, flo.cullen@somersetft.nhs.uk 01823 342582
Please refer to the attached job description for further details on the role. When completing your application please make sure to tell us how your experience and skills fit the person specification.
Person Specification
Qualifications
Essential
- Degree in life sciences, health sciences, or related field
- Good Clinical Practice (GCP) training (current/valid)
Desirable
- Postgraduate qualification in clinical research, trial management, or equivalent experience
Experience
Essential
- Substantial experience in clinical trial management or coordination, ideally including both CTIMPs and non-CTIMPs
- Proven track record of trial set-up, approvals, conduct, monitoring, and close-out
- Experience of protocol development and supporting grant applications/costings
- Experience of multi-centre trial management
- Evidence of supervising or line managing trial staff
- Experience of working with regulatory authorities, funders, and external partners
Desirable
- Experience contributing to business cases, NIHR bids, or infrastructure proposals
Additional Criteria
Essential
- In-depth knowledge of UK Clinical Trials Regulations, ICH-GCP, and research governance
- Knowledge of trial development, approvals, and monitoring requirements
- Understanding of multi-centre trial management and sponsor oversight responsibilities
- Strong project management, organisational, and problem-solving skills
- Excellent communication and interpersonal skills, with ability to influence and build strong relationships
- Ability to work under pressure, manage competing priorities, and deliver to deadlines
- Ability to manage competing priorities across a portfolio of trials and deliver to deadlines
Desirable
- Familiarity with NIHR systems, portfolio management, and national research frameworks
- Knowledge of financial management and budgeting for research studies
- Financial and resource management skills (e.g. supporting costings, budget oversight)
- Ability to contribute to strategic planning and service development
Person Specification
Qualifications
Essential
- Degree in life sciences, health sciences, or related field
- Good Clinical Practice (GCP) training (current/valid)
Desirable
- Postgraduate qualification in clinical research, trial management, or equivalent experience
Experience
Essential
- Substantial experience in clinical trial management or coordination, ideally including both CTIMPs and non-CTIMPs
- Proven track record of trial set-up, approvals, conduct, monitoring, and close-out
- Experience of protocol development and supporting grant applications/costings
- Experience of multi-centre trial management
- Evidence of supervising or line managing trial staff
- Experience of working with regulatory authorities, funders, and external partners
Desirable
- Experience contributing to business cases, NIHR bids, or infrastructure proposals
Additional Criteria
Essential
- In-depth knowledge of UK Clinical Trials Regulations, ICH-GCP, and research governance
- Knowledge of trial development, approvals, and monitoring requirements
- Understanding of multi-centre trial management and sponsor oversight responsibilities
- Strong project management, organisational, and problem-solving skills
- Excellent communication and interpersonal skills, with ability to influence and build strong relationships
- Ability to work under pressure, manage competing priorities, and deliver to deadlines
- Ability to manage competing priorities across a portfolio of trials and deliver to deadlines
Desirable
- Familiarity with NIHR systems, portfolio management, and national research frameworks
- Knowledge of financial management and budgeting for research studies
- Financial and resource management skills (e.g. supporting costings, budget oversight)
- Ability to contribute to strategic planning and service development
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
