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 provide strong operational and management support to the 5 specialist CRF units to ensure the effective use of infrastructure and resources. The post holder will work alongside the CRF Directors and other senior operational leads to ensure the timely delivery of a large and diverse portfolio of commercial and non-commercial studies undertaken in the CRF (including first-in-human Phase 1 trials and other experimental medicine studies), while ensuring compliance with regulatory research frameworks. They will be responsible for monitoring financial activity against agreed budgets, and for the development and implementation of comprehensive operational business plans and business cases for additional financial support, when appropriate. The post holder will drive the strategic development of the CRF, including working to strengthen links and collaborations with partner organisations and other NIHR funded infrastructure. The post holder will contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network. Main duties of the job Strategic development of the CRF Financial management Facilities management Human Resources management Operational management and leadership Communication and networking Working for our organisation Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best-known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield – as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation. We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark. We have a long tradition of clinical and scientific achievement and – as part of King’s Health Partners – we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients. Detailed job description and main responsibilities Strategic Development of the CRF: a) Lead on the development and implementation of a comprehensive operational business plan and business cases as required for additional financial support and resource to both internal and external audiences. b) Responsible for the development of research functions and future service delivery requirements of the adult CRFs in order to support commercial and non-commercial/academic research studies. c) Responsible for the development of key performance indicators and metrics including occupancy data in order to ensure accurate reporting of activities to the CRF Directors, BRC and R&D Departments, and the NIHR. d) Responsible for reporting the CRF metrics nationally to the NIHR in line with the contractual obligations of our NIHR CRF funding, and locally within the CRF, BRC and R&D governance structures. e) Provide expert advice and information to support the development of key strategic external peer reviewed infrastructure bids relevant to the CRF and the development of the strategic vision for the CRF. f) Working in conjunction with the adult CRF Nurse Manager, develop and maintain productive working relationships with pharmaceutical companies and the biotechnology industry partners in order to create and sustain the sound business relationships, strategic partnerships and business alliances needed to attract commercial research activities to the CRF. g) Liaise with multiple external agencies and internal departments to promote and facilitate the establishment of new clinical research studies within the adult facilities. h) Ensure that participant feedback/complaints are reported, investigated and responded to appropriately in order to improve service delivery developments and patient experience. i) Contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network and be responsible for dissemination and implementation of national initiatives within the CRF. j) Responsible for developing strategies to ensure effective collaboration with other BRC Core Facilities such as the Good Manufacturing Practice Unit and the Immune Monitoring and Flow Cytometry cores to allow the seamless transition of research activities between these facilities. k) Responsible for the strategic working relationship with other CRFs within King’s Health Partners in order to increase and maximise operational efficiencies where appropriate and to share best practice. l) Play a lead role as an Executive member of the CRF Management Team, CRF Review Board and Operations meetings as well as BRC Management meetings. Financial Management a) Lead on the development of a robust financial plan and cost recovery system for the CRF for both commercial and non-commercial research activity including the generation of income targets and monitoring of activity against such targets. b) Responsible for management of the adult CRF budget from both the NIHR CRF funding award and the delegated BRC budget, ensuring income capture, adherence to agreed budget plans, identifying savings and costs reduction in conjunction with the relevant Research Management Accountants/Financial Analysts to ensure budgets are up to date and accurate, making adjustments where required. c) Delegated signatory of up to £5k. d) Responsible for identifying costs pressures, service development and cost improvement plans and to present data on performance as required. e) Responsible for the management and maintenance of the CRF’s Asset Register on behalf of the BRC and management of any relevant associated service or maintenance contracts. Facilities Management a) To be responsible for the ongoing management and maintenance of the building, equipment and facilities, ensuring the CRF provides an environment conducive to supporting high quality clinical research in line with relevant regulatory frameworks. b) To promptly resolve any unexpected operational problems impacting on service users and safety. c) To be responsible for the procurement of all new equipment, furniture and fittings and to ensure purchases are underpinned by maintenance contracts where appropriate. d) To develop and maintain inventories/databases appropriate for good resource management and ensure that systems are in place for safety testing, servicing and maintenance as appropriate. e) Liaise with the Trust’s estates and facilities department and external suppliers in planning and implementing any repairs, improvements or other building works. f) Develop and implement a security policy for the unit and put systems in place to ensure the ongoing safety and security of staff, children and their families and investigators. g) Negotiate the annual service level agreements (e.g. the provision of cleaning services) formulated between the CRF and other service departments within the Trust, ensuring they are submitted and reviewed in a timely manner and that value for money is obtained. Act as the primary Health and Safety and Fire representative for the unit, ensuring there is an appropriate H&S structure in place to provide a suitable environment for conducting multi-disciplinary clinical research which is compliant with statutory requirements. Conduct risk analyses as appropriate. Human Resources a) Maintain a system of regular performance review and annual appraisals for all staff ensuring training and development needs are identified and met. Ensure appropriate mentors are available to all disciplines of CRF staff. b) Provide line manage for key CRF staff and lead on recruitment, induction, appraisal, training and development and retention of CRF staff as well as managing sickness and absence, disciplinary and performance issues that may arise. c) Develop workforce plans which anticipate service changes and developments and which address recruitment, retention and workforce supply issues to minimise the impact of these on service delivery. d) Lead and support organisational change to ensure efficient service delivery, productivity and compliance with Trust and CRF goals. This could include consultation with staff and promoting new ways of working, implementing new policies and procedures. Operational Management and Leadership a) Deputise for the CRF Director, Deputy Director and BRC Platforms Manager as required. b) Overall responsibility for the day to day operational management of the adult Clinical Research Facilities including operational planning to establish appropriate resources and capacity to deliver the forthcoming pipeline of clinical research in the CRF. d) In collaboration with the adult CRF Nurse Managers, provide operational leadership ensuring there is a clear framework for the delivery of high quality care and clinical research and that best practice is maintained at all times. e) Set, monitor, implement and seek to continuously improve adult CRF services in line with MHRA Phase I Accreditation, Good Clinical Practice, Research and Clinical Governance, Health and Safety, Data Protection, Infection Control and Ethics. f) Ensure that all Trust policies including child protection, vulnerable adult and Human Tissue Act legislation are adhered to by CRF staff. g) Lead by example and act as a positive role model for all staff, taking responsibility for your own professional development. h) Maintain personal standards of conduct and behaviour, which are consistent with Trust and professional standards and requirements, ensuring these standards are achieved. Communication and Networking a) Responsible for representing the CRF and the BRC at relevant internal and external meetings and conferences (national and international as required). b) Act as the lead on developing, maintaining and fostering strategic links with other national CRFs and the UK CRF Network including representation at the pan-London CRF Network. c) Responsible for promoting a positive image of the CRFs at all times especially promoting the CRFs as centres of clinical excellence for undertaking research activities in order to attract new business activities to the facility, both in the academic/NHS arena and the commercial sector. d) Responsible for promoting the CRF by proactively targeting clinical academics, research groups and organisations, building effective management links and networks with the Clusters within the BRC, Trust departments and the College, in order to ensure efficient management and development of research collaborations in relation to CRF activities. e) Establish and maintain strong links with surrounding NHS and academic partners particularly King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust within King’s Health Partners. f) Responsible for developing the patient and public involvement strategy for the CRF in partnership with the BRC, encompassing participation in Trust, UKCRF Network open days, BRC promotional events and also Trust events relating to public engagement in research. g) Act as the Trust lead in relation to showcasing the CRF in terms of infrastructure facilities and operational management, and provide advice and guidance to external visitors including government and charitable organisations on the development and management of further CRFs across the country. Educational and Training a) Facilitate the development of skills in clinical research and ensure training and development opportunities are available to all disciplines of CRF staff. b) Create and promote an appropriate learning environment across the CRFs. Person specification Qualifications / Education Essential criteria Masters degree or willingness to work towards or equivalent experience Evidence of continuing professional development Desirable criteria Management education (Diploma, MBA or equivalent experience) PRevious Experience Essential criteria Experience of working in a clinical research facility or clinical trials unit. Experience of business planning and managing a budget A track record in developing clinical research policies particularly in relation to clinical operations, clinical governance, research governance and regulatory requirements for NIHR Phase I Accreditation. Expertise in developing and reporting key performance indicators in relation to clinical research, clinical trials, clinical research operations such as occupancy, research outputs and financial data. Experience of developing new working relationships/collaborations with a broad range of commercial and non commercial organisations. Experience in managing and mentoring technical staff and dealing with significant human resource issues. Desirable criteria Demonstrable research experience or clinical trials experience at a senior level within the pharmaceutical industry Skills, Knowledge and Ability Essential criteria Strong organisational skills with proven ability to manage competing demands. A strong understanding of the issues around patients and public involvement in research. Able to deal effectively with difficult situations with staff and patients, skilled in conflict resolution. Experience of developing and delivering a training programme for a wide range of staff. Ability to analyse complex situations and produce strategic and tactical approaches to resolution. Able to collaborate constructively with internal and external partners to create the conditions for successful partnership working. Ability to work under pressure and manage/deliver within deadlines. 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 equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s 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 in to account the individual’s personal circumstances as well 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. Please apply for this post by clicking "Apply Online Now." Applicant requirements The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions. Further details / informal visits contact Name Shaun Cochrane Job title Deputy Director R&D (Operations) Email address [email protected]