Clinical Research Project Manager

University Hospital Southampton NHS Trust

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us. Please see below for a detailed job description of the role.

Main duties of the job

We are looking for a highly motivated, enthusiastic clinical research project manager to join us in the NIHR Clinical Research Facility at the University Hospital Southampton NHS Foundation Trust (UHS). UHS is one of the UK's most successful healthcare organisations. Clinical research is a core activity of the Trust and UHS aims to become one of the top 10 clinical research NHS organisations in the UK.

We are dedicated to providing high quality, patient-centred research within a state-of-the-art clinical research facility (CRF). The appointed clinical research project manager will oversee the set-up and management of the cystic fibrosis portfolio studies including managing a team to ensure the studies are coordinated appropriately.

About us

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.

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, recognizing 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.

Job responsibilities

WHAT YOU'LL DO

As a Clinical Research Project Manager, you will oversee the setup and management of the cystic fibrosis research study portfolio. This is a diverse role and responsibilities will include:

1. Managing a team to ensure trials are coordinated, prepared, set up, conducted, and closed effectively within the portfolio and conducted to required standards (ICH-GCP, EU Directive, U.K. laws and other applicable laws and regulations).
2. Ensuring trials in the portfolio are planned, set up, conducted, and closed within the defined timeframe, budget, and quality requirements including implementation of systems and processes where required.
3. Maintaining oversight of management and coordination of early phase, experimental medicine, and complex clinical research studies within the cystic fibrosis portfolio.
4. Providing a specialist role, giving expert support to Chief and Principal Investigators and patients participating in NIHR research studies.

WHAT WE'RE LOOKING FOR

• Significant experience in conducting or organising research in the NHS or other research setting
• Knowledge of current legislation regarding research governance issues
• Exceptional attention to detail and organisation skills
• Exceptional communication skills and the ability to lead a team

Person Specification Qualifications / training required

• Educated to degree level or equivalent
• Specialist qualification or significant experience in Project Management to postgraduate diploma level or equivalent
• Evidence of ongoing professional development
• International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) training
• Experience in research management
• PhD in a biomedical science

Previous or relevant experience necessary

• Significant clinical research experience in a health or relevant commercial sector
• Experience in managing teams
• Detailed knowledge of the changes in funding and research management within the NHS and in particular relating to the CRN and NIHR portfolio
• Sound knowledge of current clinical trials regulations and guidelines
• Experienced in reviewing paperwork relating to research to extract information required for a specific purpose
• Understanding of personal accountability
• Logical and consistent work and career pattern
• Recent experience in project management
• Knowledge of Research Governance Framework (RGF)
• Experience in conducting clinical research
• Recent NHS experience

Values and behaviours

• Patients First
• Always Improving
• Working Together

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.

Salary: £46,148 to £52,809 a year or pro rata