R&D Governance Manager

Guys and St Thomas NHS Foundation Trust
London
GBP 40,000 - 80,000
Job description

Guy's and St Thomas' is among the UK's busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.

Guy's is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary's Hospital in Sidcup. St Thomas' has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children's Hospital.

Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.

Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.

In February 2021 the Royal Brompton and Harefield joined Guy's and St Thomas' NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.

We have a reputation for clinical excellence and high quality teaching and research. We are part of King's Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King's College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.

Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of 'good'. Our adult community services achieved a rating of 'outstanding'.

The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.

We have one of the most ambitious capital investment programmes anywhere in the NHS.

Job overview

The post holder will be responsible for the delivery of R&D research sponsorship and co-sponsorship and the confirmation of capability and capacity of non-commercial research within the Trust, and associated research governance processes. The post-holder will also be responsible for the R&D governance and R&D performance team (17 WTE), directly managing 5 WTE.

The post will be the Trust expert in R&D governance and sponsorship and the related legislation required for governance approval and research management and may be required to provide expert governance advice on highly complex governance issues.

Main duties of the job

This is a research leadership role in one of the UK's busiest R&D departments, with one of the largest and diverse research portfolios. The post-holder will support the non-commercial research portfolio of our world-leading researchers and balance the setting up of our studies efficiently, with the governance and regulatory requirements. The post-holder will need to be an excellent communicator to people at all levels, be able to make complex decisions and ensure the R&D governance team have systems and processes that are fit-for-purpose. The candidates will need to demonstrate significant experience in NHS research management. This role requires project management, negotiation and conflict management skills, along with pragmatism and a passion for clinical research.

Working for our organisation

This is a dynamic, lively and diverse department with a high level of research activity who look forward to welcoming a leader for the governance and performance team.

This is advertised as a full-time position but we may consider 0.8 WTE for the right candidate and are open to flexible working arrangements in line with the Trust Flexible working policy. However, the post-holder will be required to work in the R&D office at Guy's hospital a minimum of three days a week and as a senior member of the R&D office will be required to attend more frequently to support the researchers and the team during pressurised periods. The R&D office is on the 16th Floor Guy's Tower will work across all hospital sites within the organisation and across KCL campuses.

Detailed job description and main responsibilities

The role includes:

  1. Management of a robust research governance management systems that ensure compliance with all relevant regulations and legislation, for example Human Tissue Act, Medicines Act, Data Protection Act, GDPR, HRA, MHRA and EMEA.
  2. Management of R&D SOPs, Research Governance Manuals (RGMs), templates and documents under a QMS (Quality Management System) to ensure that research is compliance with the UK Policy for Health and Social Care Research.
  3. Ensuring that all data that is collected and recorded is accurate by the R&D Governance team within the Trust's R&D Database(s).
  4. Plan and develop R&D database and IT systems, and their integrations with Trust and JRO systems e.g. EPIC and Joint Research Office websites and other future developments.
  5. Attract, train and retain a talented R&D Governance and Performance management team.

Person specification

Knowledge/Qualifications

Essential criteria
  • Masters degree or equivalent experience

Desirable criteria
  • Project Management Qualification

Experience

Essential criteria
  • Experience of dealing positively with organisational politics
  • Significant experience of clinical research management, to include experience in the planning, coordination and conducting of clinical research studies or the management of clinical research.
  • Evidence of working and supporting key performance targets and delivering benefits
  • Significant experience of leading and managing staff including HR processes and policies

Desirable criteria
  • Experience of working in the NHS and/or academia

Skills

Essential criteria
  • Able to take the lead and facilitate new initiatives/change
  • Significant influencing and persuasion skills
  • Extensive knowledge of UK clinical research and its changing environment
  • Equality, Diversity and Inclusion Champion for the department
  • Champion of Research Quality and compliance
  • Attention to Detail

Guy's and St Thomas' celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitably according to their needs. We are actively committed to ensuring that no one who applies for a job, works or studies at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity, gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.

Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.

As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.

Flexible working

We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking into account the individual's personal circumstances as well as the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.

Your e-mail address is important to us - We communicate to all job applicants via the e-mail address which has been provided on the application form. Please ensure that you check your e-mail on a regular basis.

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