Research and Innovation Quality Assurance Manager

Job Overview Are you an experienced research professional with a passion for quality, governance and continuous improvement? We are seeking a dynamic and motivated R&​I Quality Assurance Manager to lead and strengthen quality across our Research &​ Innovation (R&​I) service.

This is an exciting opportunity to play a pivotal role in ensuring that research at Frimley Health is delivered to the highest standards of safety, compliance and excellence.

Main duties of the job

As the R&​I Quality Assurance Manager, you will be accountable for the development, implementation and continuous improvement of the Trust’s Research Quality Management System (QMS) . You will provide assurance that all research activity is conducted in line with regulatory requirements, including ICH-GCP, UK Clinical Trials Regulations and the UK Policy Framework.

You will lead a proactive, risk-based programme of audit, monitoring and inspection readiness , providing expert advice to research teams, investigators and senior leaders across the Trust.

Working closely with the Head of Research &​ Innovation and wider R&​I leadership, you will embed a strong quality culture and support continuous improvement across all research activity.

Working for our organisation

Frimley Health NHS Foundation Trust is committed to being an inclusive and disability confident employer and has been awarded the Gold for the Armed Forces Employment Recognition Scheme. We provide first class development opportunities for all staff and have a wide range of professional, management and leadership, and clinical skills training available.

At Frimley Health NHS Foundation Trust, research is at the heart of improving patient care. We are committed to fostering a culture of excellence, innovation and collaboration.

Here at Frimley Health NHS Foundation Trust, we know how important it is to have a healthy work life balance; this benefits not only individuals but the patients we care for too.

We encourage applications from people who wish to work on a flexible basis, recognising that flexibility may mean a range of different working patterns and hours, we do our utmost to work with our staff to meet their needs and the needs of our service and its users.

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Detailed Job Description And Main Responsibilities For a full list of tasks and responsibilities for this role please see the attached job description.

Person specification

Qualifications Essential criteria

• Degree (or equivalent level of professional experience and/or knowledge) in a relevant subject (e.g., life sciences, health, nursing, pharmacy or related)
• ICH-Good Clinical Practice (GCP) trainer expertise as NIHR certified GCP facilitator.
• Evidence of training and/or experience in quality assurance, audit, monitoring, governance or research operations management.

Desirable criteria

• Postgraduate qualification (e.g. Masters) or equivalent experience.

Experience Essential criteria

• Substantial experience managing clinical research in an NHS, academic, CRO or pharmaceutical setting with a focus on research quality assurance and research governance.
• Experience of planning and conducting audits/monitoring (e.g., systems, process or study/site level), writing reports and managing CAPA to closure.
• Experience preparing for and/or supporting regulatory inspections or sponsor/CRO audits.
• Experience of SOP/document control and supporting training compliance (e.g., issuing SOP training and maintaining training records/metrics).

Desirable criteria

• Experience across a broader range of regulated research (e.g., CTIMPs, medical devices/ISO 14155, tissue/HTA).

Skills and Knowledge

Essential criteria

• Specialist working knowledge of key research regulations and guidance (e.g., ICH-GCP, UK Policy Framework; clinical trials regulations as relevant).
• Excellent written and verbal communication skills; able to convey complex regulatory information clearly and constructively.
• You will be able to clearly demonstrate your knowledge and understanding of current UK clinical trial regulations, good clinical practice
• Strong analytical skills with ability to interpret findings, identify trends and propose proportionate, risk-based actions.
• Excellent written and verbal communication skills; able to convey complex regulatory information clearly and constructively.
• Highly developed specialist working knowledge on clinical research management and compliance to regulatory requirements.

Desirable criteria

• Knowledge of broader quality standards/frameworks (e.g., ISO, GMP/GCLP) relevant to research delivery.
• Experience of developing training materials and delivering education sessions. Special Requirements
• Ability to travel and work across Trust sites and external locations as required to support audit/inspection activity.
• Demonstrates professional judgement, integrity and discretion when handling sensitive information.
• Commitment to equality, diversity and inclusion and to delivering a positive experience for research participants and staff.

Frimley Health NHS Foundation Trust (FHFT) is proud of its strong reputation, record of achievement and ambition for the future. We serve a population of over 900,000 people across Berkshire, Hampshire, Surrey and South Buckinghamshire, and remain committed to improving the health and wellbeing of our communities. Our new organisational strategy – FHFT 2030 – sets out our ambition to be the best place to receive care and the best place to work in the NHS. Underpinned by our Trust values – Committed to Excellence, Working Together, Facing the Future , and being a modern, compassionate, Healthcare Organisation – we are creating a culture where our people can thrive and patients always come first. We continue to invest heavily in our services and facilities. This includes the development of a new hospital at Frimley Park, major expansion of diagnostics and inpatient capacity, and the continued transformation of services across our sites. We have already delivered a brand-new £100m state-of-the-art Heatherwood Hospital, a £49m Emergency Assessment Centre at Wexham Park, and a £10m upgrade to maternity services. We are also committed to sustainability and the NHS Net Zero ambition. Our new hospital and estate developments are being designed to be environmentally responsible, energy efficient, and future-proofed, featuring on-site renewables energy and intelligent energy systems. Through our green plan, we are embedding sustainable practices across all areas of care and operations, ensuring we reduce our environmental impact while improving population health and wellbeing. Our staff are key to helps us deliver on our ambition and to ensure sustainability is a core component of care delivery and our operations. Alongside estates’ investments, we are embedding a strong focus on digital innovation and quality improvement. Our electronic patient record (Epic), launched in 2024, is already enabling safer, more connected, and more effective care for patients, while giving staff the tools they need to do their best work. Our electronic patient record also supports safe and effective digitised care pathways, savings time and carbon, whilst delivering excellent quality of care. Everything we do is guided by our values, shaping how we care for patients, support colleagues, and build a sustainable future for healthcare together. Apply online now