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 postholder will be responsible for: · the safe, efficient and effective operational delivery of the oncology and haematology clinical trial service at Guy’s and St Thomas’ NHS Foundation Trust in compliance with The Medicines for Human Use (Clinical Trials) Regulations and GCP Directive · measuring, monitoring and improving key performance indicators · recruiting, retaining and developing the OHCT workforce to deliver a competitive, high quality clinical trials service · staff line management as required The postholder will work as part of the OHCT SMT (Service Management Team) and with key stakeholders (including PIs, research teams, pharmacy, KHP Clinical Trials Office and GSTT R&D) and will be expected to identify service needs in order to develop innovative solutions for service improvements. Main duties of the job To be accountable for operational delivery of the Oncology and Haematology Clinical Trials Service. To maintain a current knowledge and awareness of recent developments in cancer research and clinical research and to demonstrate continuing professional education and development. With the Business Development and Initiation Manager, report on income to the OHCT Clinical Lead, Directorate Management Team and Finance Manager as well as review outgoing costs to identify cost saving efficiencies. To develop and maintain a culture, of openness, support, quality, safety and honesty within OHCT. Assume overall responsibility for OHCT communication and provide a communication infrastructure, including preparation and delivery of presentations, reports and newsletters or meetings detailing local and national initiatives and performance. This may include setting up OHCT intranet and internet web presence. 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. Our values help us to define and develop our culture, what we do and how we do it. It is important that you understand and reflect these values throughout your employment with the Trust. The post holder will: Caring – we put patients first We provide patient and person-centred care. We care about others’ needs and wellbeing. We listen. We are compassionate to ourselves and others. We reflect on our actions. We are respectful and welcoming. Ambitious – we innovate and strive for excellence We innovate and strive for excellence. We act with integrity. We act on staff and patient feedback. We seek ways to improve the care and experience of others. We are efficient. We are committed to growth. We find new ways to deliver excellence. Inclusive – we respect each other and work collaboratively We respect each other and work collaboratively. We act on diverse views. We put ourselves in ‘others’ shoes’. We are building an anti-racism organisation. We seek opportunities to collaborate. We show sensitivity towards diversity of culture Detailed job description and main responsibilities Operational Management To be accountable for operational delivery of the Oncology and Haematology Clinical Trials Service Accountable for OHCT workforce planning including advertisement of and recruitment to vacancies, identification of areas where new post development is needed and work closely with the OHCT SMT to ensure financial accountability for new and existing OHCT funded positions To work with OHCT SMT to review and upkeep the Electronic Staff Record, ensuring roles are budgeted and recruited to in line with agreed financial streams and Trust policy Responsible for business planning for OHCT throughout the year ensuring implementation of strategic plans as agreed by the SMT and/or DMT and performance targets are met. Responsible for performance management of Research Team Leads and other members of OHCT in terms of delivery of research within their teams as needed across the service Work closely and collaboratively with the OHCT SMT to ensure effective systems are in place for swift and effective study set up and smooth delivery of agreed oncology and haematology clinical trials Engage with the Clinical Research Network and Experimental Cancer Medicine Centre team to manage and report on externally-funded positions within OHCT Responsible for ensuring EDGE reporting complete for trials running within OHCT Responsible for ensuring systems are in place to record and measure key performance indicators/metrics for OHCT, recording and monitoring KPIs, identifying and highlighting deficiencies with plans for improvement where necessary, implementing improvement, presenting data at the weekly SMT meeting To work with the OHCT Clinical Lead and Oncology/Haematology R&D Leads to ensure quality and compliance expectations are met by the Cancer Principal Investigators To develop and maintain detailed oversight of appropriate governance systems for ensuring compliance with internal and external standards and shared learning and to ensure that OHCT remains adequately prepared for regulatory inspections. Build and maintain close working relationships with the GSTT Research and Development Team and the King’s Health Partners Clinical Trials Office. They are expected to work collaboratively to ensure smooth running of trials across the commercial and non-commercial portfolio To attend meetings where required along with members of the wider Trust R&D team to engage in shared learning and to disseminate information on new processes To formally link with departments relevant to the conduct of OHCT research and maintain strong links with the Radiotherapy Research Group To ensure good working relationships between research staff and other clinical services To develop effective links with the NIHR Networks to inform funding and performance across OHCT. Be responsible, in collaboration with the OHCT SMT for development and maintenance of systems and procedures to ensure quality delivery and compliance with national regulations & policy as well as GSTT policy. Be responsible, in collaboration with the OHCT SMT for the coordination of all regulatory inspection within the OHCT Be responsible, in collaboration with the OHCT SMT for ensuring findings from regulatory inspections and audits are shared within OHCT and other relevant staff and that findings are addressed promptly Maintain detailed awareness of current portfolio of research and the impact on teams and service support departments Troubleshoot problems with clinical trials as they arise, communicate any issues with the OHCT SMT and share learning via educational events or implementation of new OHCT policies and procedures To identify barriers to participation in clinical trials within the organisation and develop strategies for improving recruitment To participate in the investigation and resolution of patient complaints related to clinical trials in compliance with Trust policy Attend meetings with KHP Clinical Trials Officials as required to ensure strong operational delivery of the service. Professional and Academic · To maintain a current knowledge and awareness of recent developments in cancer research and clinical research and to demonstrate continuing professional education and development. · To keep up to date with regulatory requirements relating to the conduct of clinical research, including the EU Clinical Trials Directive, GCP Directive, Human Tissue Act, as well as ICH GCP and the Research Governance Framework and appropriate ethical process. · Presentations to academic, medical, technical, and nursing staff and presentation of data at scientific meetings, nationally and internationally · To teach and supervise staff working in oncology and haematology clinical research as appropriate · Oversee the development and implementation of appropriate teaching and education sessions Financial · With the Business Development and Initiation Manager, report on income to the OHCT Clinical Lead, Directorate Management Team and Finance Manager as well as review outgoing costs to identify cost saving efficiencies · Responsible for negotiating with the NIHR CRN South London to access resource for OHCT. · Identify and pursue/support, where applicable, the potential additional sources of income for supporting OHCT clinical trials at GSTT · To plan for instrument purchases on an ongoing basis and to evaluate and secure competitive quotations for the purchase of all equipment necessary for the service. · To have oversight of research team management of invoicing and review regularly in performance review meetings Personnel · To develop and maintain a culture, of openness, support, quality, safety and honesty within OHCT. · To develope workforce plans for OHCT and develop systems for education development and learning within the team. · To be responsible for the recruitment and appointment of all relevant Clinical Research Support staff. · Monitor rates of Statutory Mandatory Training across the team in line with Trust targets · To be responsible for the performance management, objective setting and effectiveness of direct reports · To work with the OHCT Research Matron and other senior nursing colleagues as needed to ensure that there is a coordinated approach to the appointment, structure and appraisal of nursing staff within OHCT. · To support recruitment and retention initiatives within OHCT. · To promote good working relationships between members of the department and with other hospitals. · Ensure that staff are able to carry out their duties free from harassment and bullying, adhering to hospital guidelines. · To implement personnel policies on matters of welfare, counselling, grievance and disciplinary procedures. · To ensure sickness and annual leave records are maintained on all staff members. · Where responsible for staff ensure performance managed by annual appraisal and that all staff have a Personal Development Plan, adhering to hospital performance management policies. · Responsible for overseeing the implementation of an induction and training programme for all Clinical Research Support staff. Information Management &Communication · To attend SMT meeting, ensuring good governance with a focus on action delivery and communication. · Assume overall responsibility for OHCT communication and provide a communication infrastructure, including preparation and delivery of presentations, reports and newsletters or meetings detailing local and national initiatives and performance. This may include setting up OHCT intranet and internet web presence. · To lead on preparation of OHCT performance report in consultation with SMT to discuss at the monthly PRMs (performance review meeting). To review new trials for adoption into the portfolio and sit as a member of the OHCT Adoption Committee, highlighting any potential operational issues of the upcoming trials. · To lead the OHCT Management Meeting each month on operational issues t o keep all staff informed of departmental and Trust issues (eg joint staff meetings, team briefings, one-to-one meetings) · To co-ordinate and present at quarterly PI research lead/OHCT meetings · To maintain a record of OHCT academic and scientific outputs and other key achievements · Generate a quarterly OHCT newsletter · Generate an annual report on research activity within OHCT Person specification Education/Qualifications Essential criteria First degree or equivalent in scientific/healthcare related discipline Desirable criteria MSc in Scientific, healthcare or related discipline or equivalent experience of operational management of clinical trials within the NHS Management Qualification Previous Experience Essential criteria Significant experience of working in clinical research Operational experience of working with multiple clinical trials involving IMPs and ATMPs Previous experience of working at a managerial level including management of staff Experience working in the NHS Experience of Clinical Trial set up including contract and budget negotiation Experience of working on local studies, national academic and commercial studies Expert experience of working to UK clinical trial regulations & ICH GCP Proven track record of management of clinical trial delivery Desirable criteria Experience of project management Experience of working in the field of Oncology/Haematology Skills/Knowledge/Ability Essential criteria Detailed knowledge of scientific conduct of clinical research including the planning, co- ordination and conduct of clinical trials Understanding of National research policy and current issues in the NHS Detailed knowledge of Good Clinical Practice and Research Governance together with the ability to disseminate the knowledge and information Familiarity with the issues surrounding clinical data, particularly confidentiality Knowledge of NIHR and Department of Health research priorities Proven ability to provide leadership Well developed interpersonal and communication skills; able to work with clinical and management colleagues at all levels across a range of organisations Organisation and time management skills to manage and deliver a range of complex tasks and projects to tight deadlines IT skills particularly in the use of MS Office applications Ability to analyse and interpret specialised, confidential research management information and ability to make judgements regarding a range of complex research management issues Excellent negotiating skills Ability to assess clinical trial protocols for impact and deliverability Understanding of costing studies and managing finance Ability to manage change and convey contentious information Flexible approach to working, including problem solving skills, management of change and a desire to develop knowledge Ability to work within a team Attention to detail Highly motivated with the ability to influence and inspire others Able to adapt style to the needs of the situation Confidence to act on own initiative and take ideas forward Capacity to manage a demanding workload and deliver work to 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 Dr Rebecca Kristeleit Job title Consultant Medical Oncologist Clinical Lead OHCT Email address [email protected] Additional information Antoine Lehman General Manager [email protected]