Senior QA Lead (Data and Information governance)

University Hospital Southampton NHS FT; Southampton; On-site; GBP 40,000 - 55,000; Full time

Job summary

A prominent healthcare organization in Southampton seeks a motivated R&D Quality Assurance Officer to oversee clinical data use for research, ensuring compliance and quality standards. This role supports various departments, fostering collaborative relationships and promoting high-quality governance in research. Candidates should possess a Master's degree and strong IT and interpersonal skills. The position offers a flexible work environment to enhance work-life balance.

Qualifications

• Experience of undertaking, coordinating or managing clinical research.
• Up-to-date knowledge of major regulatory issues governing clinical research.
• Evidence of continual professional development.

Responsibilities

• Develop relationships with researchers and staff to ensure cooperation.
• Ensure QA activities are documented and the Trust is inspection ready.
• Support R&D governance and prepare for audits.

Skills

Excellent interpersonal and communication skills

Excellent IT skills

Understanding of governance requirements

Flexible approach to work

Education

Master's degree or equivalent

Tools

MS Office

Various databases

Job description

Job Overview

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.

Please see below for detailed job description of the role.

Main duties of the job

We are looking for a highly motivated research quality assurance lead working at the cutting‑edge of NHS data research within the R&D department at UHS. This post will have specific responsibility for the use of clinical data for research and information governance.

This post forms part of a collaborative team to support the delivery of the Wessex Secure Data Environment (SDE programme – a national programme to increase the safe use of clinical data for research) and Southampton Emerging Therapies and Technologies (SETT) Centre to scale data research across the region.

Working for our organisation

University Hospital Southampton is one of England’s largest acute teaching Trusts, offering a wide range of learning and development opportunities to support your career aspirations.

Located on the south coast with an international airport and direct rail links to London, Southampton offers an ideal setting to live and work, with the New Forest, South Downs and Jurassic Coast.

We believe that using technology wisely shows strong time management and commitment to innovation. However, personalising your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI‑generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.

At UHS we’re committed to providing a flexible working environment where possible. Whether you are balancing family, study, or your wellbeing with your career, we want to support you so you can help our patients.

At UHS, we proudly champion individuality, recognising that outstanding care is only possible with a diverse, inclusive team. We’re committed to creating an anti‑racist, anti‑discriminatory environment where everyone feels valued, safe, and empowered to make a meaningful impact in our communities. We welcome applicants of all backgrounds, identities, and experiences to join us in building a healthcare community where everyone can belong, thrive, and contribute.

About The Team

Detailed job description and main responsibilities.

The research and Development Department at University Hospital Southampton are looking for an R&D Quality Assurance Officer who will take responsibility for the safe delivery of research studies by the trust. A key responsibility of the role is to ensure that all QA activities are carried out and documented so that the Trust is inspection ready at all times. The role is varied as it included working with a variety of teams and colleagues to provide a safe, quality focussed framework for research at the trust.

UHS and University of Southampton partnership is recognised as a centre of excellence in clinical research. With state‑of‑the‑art research facilities and research recognised as a key pillar of improving patient care the trust is one of the top research active trusts in the country.

The SETT Data & AI Research Unit is the data science arm of the hospital – supporting clinical research through the design of scalable and reproducible analytical/ML pipelines. The SETT Data team are a highly collaborative and forward‑thinking team at the forefront of NHS data research and are passionate about unlocking clinical data at scale to drive better outcomes for our patients.

The SETT data team are also an integral part of the Wessex SDE programme hosted by UHS. The Secure Data Environment programme is a national programme aimed at maximising the use of NHS data providing safer, more secure, and faster access to different types of NHS data as well as ensuring consistent standards and interoperability.

What You’ll Do

• Work closely with a number of teams and individuals in R&D, SETT, the SDE as well as the wider Trust/region to ensure the delivery of the UHS R&D strategy and SDE programme meet regulatory and governance needs.
• Support the R&D Governance, Quality Assurance and Sponsorship Manager.
• Support the SDE Ops Director in the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Trust with specific oversight of data and IG systems. This will include but is not limited to SOPs, Policies, Risks and Issues Management and accreditation and compliance with DHSC and other organisational standards.
• Support the Trust and SDE preparation for external audit and regulatory inspection.
• Assist in the delivery of QA initiatives to ensure that the Trust and SDE meets required standards for the conduct of clinical research.
• Assist with the development and use of systems for recording and collating information for audits, using analytical skills to interpret metrics information required for audit reporting methods.
• Support the general administration of the QA team.

What We’re Looking For

This post requires a dynamic, out‑going person since a key aim in the role will be to develop relationships with researchers and other staff to ensure cooperation with the quality agenda. Good IT skills are essential and the successful applicant should be able to provide evidence of continuing professional development.

The following skills and experience are required for this post:

• An understanding of the governance requirements surrounding clinical research in the NHS.
• An excellent understanding of the use of clinical data for research in the NHS, including HRA and IG understanding and expectations.
• An understanding of R&D issues in the NHS.
• Excellent interpersonal and communication skills.
• Excellent IT skills, particularly in the use of web applications.
• A flexible approach to work and the ability to adjust workload to changing priorities.

Person specification

Trust Values

• Patients First
• Always Improving
• Working Together

Qualifications, Knowledge And Experience

Essential criteria

• Master’s degree or equivalent professional knowledge underpinned by relevant training and experience.
• Experience of undertaking, coordinating or managing clinical research, either from an academic or commercial setting.
• Up to date knowledge of major regulatory issues governing the conduct of clinical research.
• Evidence of continual professional development.
• Information Governance experience.
• Current certificate in ICH GCP (International Conference on Harmonisation Good Clinical Practice).
• Experience of implementing new systems.
• Experience providing training.
• Proven ability to maintain highly complex information sources and databases.
• Project Planning and management experience.
• Experience of influencing senior academic/clinical members of staff.
• Excellent written and verbal communication.
• Good inter‑personal skills – must be able to influence and motivate others to achieve results.
• Able to analyse highly complex information and make appropriate judgements.
• Methodical with good organisational skills with attention to detail.
• Good time management skills – able to plan and work to agreed timescales and to multi‑task effectively.
• Excellent IT skills, including MS Office, internet and various databases.
• Evidence of ability to motivate others.
• Ability to listen to others and use critical questioning of techniques.
• Ability to prioritise and quickly identify the main core issues in a situation.
• Ability to use problem solving skills.
• Knowledge of the inspection and regulation environment in which the Trust operates.
• Sound knowledge of the Research, Clinical, Information and Corporate Governance agendas. Good understanding of confidentiality issues.

Desirable criteria

• Experience of Clinical Data for research.
• QA Management experience.
• Clinical /Laboratory qualification or training.
• Teaching/training qualification.
• Evidence of continual professional development within a management role.
• Coaching and mentoring experience.
• Experience of implementing new systems within a research environment.
• Recent NHS experience with logical and consistent work and career pattern.
• Experience of re‑design or change management initiatives.
• Experience of regulatory inspections.