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An exciting opportunity has arisen to play a leading role in the highly successful University of Oxford’s Primary Care Clinical Trials Unit (PC-CTU), as Head of Operations. Working closely with the CTU Director and Deputy Director Academic as well as the Head of Administration for the department, the Head of Operations has a key management role in the delivery of all the operational aspects of the CTU to support the department’s strategy to undertake the highest quality research in primary care. You will lead the trial management functions and provide senior clinical trials operations leadership and oversight of procedures; ensuring that the professional development of trial operations staff, the development of trial grant applications and the delivery of funded trials is of the standards expected of a registered CTU. You will take an active role in the overall development of CTU including attracting new business and funds. You will also work closely with Chief Investigators within and outside the Department, and provide the management expertise and input to support the CTU operational activities. You will have excellent interpersonal skills and the ability to build strong and productive working relationships across the department and beyond. You will work to high standards across a variety of tasks with constant regard to scientific and regulatory requirements. You will need a doctorate in a relevant subject or extensive relevant experience in trial management in a high performance environment, and have significant experience of clinical research management at a senior level. You will have strategic experience in planning, coordination and conduct of clinical trials with extensive experience in line managing teams of staff and in managing budgets. The PC-CTU is part of the UKCRC fully registered Oxford Primary Care and Vaccine Collaborative CTU. The Unit’s portfolio encompasses a wide range of health research, including but not limited to Behavioural Research and Others, Cardiovascular and Renal, and Infections themes. The majority of studies undertaken by the PC-CTU are multi-centre randomised controlled trials with a primary care focus evaluating complex interventions to improve outcomes for patients. At any one time the Unit has about 80 staff working on a portfolio of about 40 clinical trials and other well-designed studies. This thriving Unit is the only dedicated primary care generic clinical trials Unit in the UK and has an exciting portfolio of current studies with an exciting and solid pipeline. You will be based in the Gibson Building, Nuffield Department of Primary Care Health Sciences, Woodstock Road, Oxford, OX2 6GG as your normal place of work but you may be able to agree a pattern of partial remote working with your line manager. We would be interested in receiving application from individuals interesting in undertaking the role on either a permanent or interim basis. For further information or to discuss the post please contact Professor Chris Butler, Clinical Director (Christopher.butler@phc.ox.ac.uk) or Associate Professor Ly-Mee Yu, Deputy Director Academic (ly-mee.yu@phc.ox.ac.uk) “Committed to equality and valuing diversity” The closing date for applications is **noon on 13 November 2023** Interviews are expected to be held on 29 November 2023
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Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG
An exciting opportunity has arisen to play a leading role in the highly successful University of Oxford’s Primary Care Clinical Trials Unit (PC-CTU), as Head of Operations. Working closely with the CTU Director and Deputy Director Academic as well as the Head of Administration for the department, the Head of Operations has a key management role in the delivery of all the operational aspects of the CTU to support the department’s strategy to undertake the highest quality research in primary care. You will lead the trial management functions and provide senior clinical trials operations leadership and oversight of procedures; ensuring that the professional development of trial operations staff, the development of trial grant applications and the delivery of funded trials is of the standards expected of a registered CTU. You will take an active role in the overall development of CTU including attracting new business and funds. You will also work closely with Chief Investigators within and outside the Department, and provide the management expertise and input to support the CTU operational activities. You will have excellent interpersonal skills and the ability to build strong and productive working relationships across the department and beyond. You will work to high standards across a variety of tasks with constant regard to scientific and regulatory requirements. You will need a doctorate in a relevant subject or extensive relevant experience in trial management in a high performance environment, and have significant experience of clinical research management at a senior level. You will have strategic experience in planning, coordination and conduct of clinical trials with extensive experience in line managing teams of staff and in managing budgets. The PC-CTU is part of the UKCRC fully registered Oxford Primary Care and Vaccine Collaborative CTU. The Unit’s portfolio encompasses a wide range of health research, including but not limited to Behavioural Research and Others, Cardiovascular and Renal, and Infections themes. The majority of studies undertaken by the PC-CTU are multi-centre randomised controlled trials with a primary care focus evaluating complex interventions to improve outcomes for patients. At any one time the Unit has about 80 staff working on a portfolio of about 40 clinical trials and other well-designed studies. This thriving Unit is the only dedicated primary care generic clinical trials Unit in the UK and has an exciting portfolio of current studies with an exciting and solid pipeline. You will be based in the Gibson Building, Nuffield Department of Primary Care Health Sciences, Woodstock Road, Oxford, OX2 6GG as your normal place of work but you may be able to agree a pattern of partial remote working with your line manager. We would be interested in receiving application from individuals interesting in undertaking the role on either a permanent or interim basis. For further information or to discuss the post please contact Professor Chris Butler, Clinical Director (Christopher.butler@phc.ox.ac.uk) or Associate Professor Ly-Mee Yu, Deputy Director Academic (ly-mee.yu@phc.ox.ac.uk) “Committed to equality and valuing diversity” The closing date for applications is noon on 13 November 2023 Interviews are expected to be held on 29 November 2023
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Job Description _________________________________________________________________________ Summary Job title Head of Operations Division Medical Sciences Department Primary Care Health Sciences Location Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG Grade and salary Grade 9: £52,815 - £61,198 p.a.(with discretionary range to £66,857) Hours Full-time Contract type Permanent Reporting to CTU Director (with link to Head of Administration and Finance) Vacancy Reference BZ23113 - 167914 The role This key position requires an Operations Manager with a high degree of expertise in clinical trial management who can develop and implement systems and processes to support the development of the CTU and the Department’s strategy to undertake the highest quality research in primary care. The portfolio of the Primary Care Clinical Trials Unit is grouped into three themes: Infection; Cardiovascular and Metabolic Medicine; and Behavioural Medicine and Others. The majority of studies are multi-centre randomised controlled trials with a primary care focus evaluating complex interventions and/or controlled trials of investigational medicinal products to improve the evidence base supporting quality clinical care for patients. Since the pandemic we have broken new ground with the establishment of platform trials in primary care. The post holder will work closely with the Director and Deputy Director to build relationships across the Department and other clinical departments, the NIHR Clinical Research Network and other external agencies, to maintain and deliver a portfolio of funded clinical trials. The post holder will have the vision and leadership skills to deliver a strategy of continuous development, benchmarking against similar units, ensuring high quality professional development for the trial management team and a positive, inclusive working environment. Responsibilities Policy, strategy and planning • Articulate the vision for clinical trial management in the CTU • Work closely with the leadership team to deliver the CTU strategy and with the Head of Administration and Finance to plan the funding and resources of the CTU • Ensure policies and procedures are deeply and efficiently embedded to comply with regulatory requirements and act as a beacon of best practice • Represent the CTU at University, national or international meetings. Staff management • Be responsible for planning, coordinating and managing resource requirements for the trial portfolio deploying staff effectively and efficiently. • Line manage the senior trial managers, overseeing their induction, probation, objectives, performance management, personal development in accordance with departmental and University policies and procedures liaising closely with the HR team where appropriate. • Model good leadership and support the senior trial managers in management of their teams. • Develop and implement a professional development strategy for CTU staff, facilitating access to appropriate training opportunities. Trial management • Oversee the day-to-day activities of the CTU and to ensure a robust operational input into all aspects of clinical trial management and delivery. • Seek out, evaluate and implement improvements to systems and processes as part of a continuous improvement culture • Provide high level trial management strategies across functions, co-ordinating the trial management, programming, data management, and strong research nurse teams, statistics, and QA in order to deliver high quality and efficient studies. • Ensure trials run by the CTU are in compliance with the CTU standard operating procedures. • Liaise with the Research Governance, Ethics and Assurance Team to ensure that all studies have the appropriate regulatory approval and sponsorship • Keep abreast of, and respond to, changes in legislation and regulatory requirements and other developments that may impact on the work of the CTU • Lead the CTU internal and external audits, and regulatory inspections • Promote the work of the CTU within the University and in relevant local/regional research networks • Proactively curate positive networks and relationships to the benefit of internal and external stakeholders Financial • Contribute to grant applications by providing expert advice on study design and trial management aspect of the clinical trials along with an achievable, best value budget for the trial. • Be proactive in securing new funding to ensure the stability and sustainability of the unit. • Oversee the budgets of all trials across the portfolio supporting senior trial managers in budget management of individual trials and work with the Head of Administration and finance teams to monitor budgets and plan resource requirements. Other • Work with colleagues to deliver a Clinical Trials Management module on the MSc Evidence Based Health Care. CTU Head of Operations JD Final_Ly-Mee Yu.docx 2 • Travel on University business within the UK and/or outside of the UK to attend meetings, seminars or conferences as and when appropriate. You can expect to spend up to 2 weeks on University business travel per year. Selection criteria Essential Criteria • PhD in a relevant subject or extensive research experience • Significant experience of clinical research management at a senior level, to include strategic experience in planning, coordination and conduct of clinical trials • Excellent project management skills • A strong track record of leading and managing a team of staff ensuring professional development and resource management • Excellent knowledge of the EU Clinical Trials Directive, UK Clinical Trials Regulations, Principles of Good Clinical Practice and research governance framework legislation together with the ability to disseminate the knowledge and information. • Experience in quality management/clinical trials audits and inspections. • Experience in costing and budgeting studies, financial processes and budget management • Excellent communication skills, able to build working relationships at senior levels and manage diverse teams. • Pro-active and strong problem-solving skills. Desirable Criteria • Experience of developing materials and delivering teaching to post-graduate students. Pre-employment screening Standard checks If you are offered the post, the offer will be subject to standard pre-employment checks. You will be asked to provide: proof of your right-to-work in the UK; proof of your identity; and (if we haven’t done so already) we will contact the referees you have nominated. You will also be asked to complete a health declaration so that you can tell us about any health conditions or disabilities for which you may need us to make appropriate adjustments. Please read the candidate notes on the University’s pre-employment screening procedures at: https://www.jobs.ox.ac.uk/pre-employment-checks Additional security pre-employment checks This job includes duties that will require additional security pre-employment checks (clinical trial management): • University security screening (eg identity checks) About the University of Oxford Welcome to the University of Oxford. We aim to lead the world in research and education for the benefit of society both in the UK and globally. Oxford’s researchers engage with academic, commercial and cultural partners CTU Head of Operations JD Final_Ly-Mee Yu.docx 3 across the world to stimulate high-quality research and enable innovation through a broad range of social, policy and economic impacts. We believe our strengths lie both in empowering individuals and teams to address fundamental questions of global significance, while providing all our staff with a welcoming and inclusive workplace that enables everyone to develop and do their best work. Recognising that diversity is our strength, vital for innovation and creativity, we aspire to build a truly diverse community which values and respects every individual’s unique contribution. While we have long traditions of scholarship, we are also forward-looking, creative and cutting-edge. Oxford is one of Europe's most entrepreneurial universities and we rank first in the UK for university spin-outs, and in recent years we have spun out 15-20 new companies every year. We are also recognised as leaders in support for social enterprise. Join us and you will find a unique, democratic and international community, a great range of staff benefits and access to a vibrant array of cultural activities in the beautiful city of Oxford. For more information, please visit www.ox.ac.uk/about/organisation. Nuffield Department of Primary Care Health Sciences A top ranked centre for academic primary care in the UK, we lead world-class research and training to rethink the way healthcare is delivered in general practice and other primary care settings, both across the UK and globally. Integrating evidence and innovation, our main research focus is on enhancing prevention, early diagnosis and management of common illness. Our research is led by internationally renowned scientists, many of whom are practising GPs and primary care clinicians, and public health physicians, but we also have academics from a range of non-medical disciplines including the social sciences and humanities. We cover the broad range of issues that you might expect to consult in the community about including cardiovascular and metabolic disease, infectious diseases and childhood illness, diet, smoking and cancer. We also focus on understanding and improving the experiences of patients, rigorously evaluating the effectiveness of treatments and diagnostics, utilising big data, developing digital health interventions and working internationally. We have methodological expertise in novel clinical trial design and implementation, clinical decision making and diagnostics, clinical epidemiology, medical statistics, modelling, qualitative research and the wider application of social science theory and methods to address practical and theoretical challenges in health and care settings. The department was established in October 1998 (as the Department of Primary Health Care) with the appointment of a foundation chair in general practice, and was made a free-standing department in 2011 with the first Oxford statutory chair in primary care. We provide a strong multi-disciplinary training environment, a full programme of academic support and good IT facilities. Our ability to collaborate with other epidemiological and community based research groups across the University and with GP surgeries locally and nationally enables us to utilise a broad range of relevant expertise into our teaching and research. Our main research themes coalesce around cardiovascular disease and diabetes, infection, cancer, health behaviours, and digital health, with several cross-cutting themes, including disease prevention, early diagnosis, and patient self-management, big data and new clinical themes. We place inclusivity and diversity at the forefront of our approach to research from design and conduct through to the dissemination of our findings. The department has exceptional infrastructure, including the long-established Primary Care Clinical Trials Unit, one of the most expert CTU’s for trials conducted in community settings. We also host the Oxford Institute for Digital Health, the Bennett Institute for Applied Data Science, the Oxford Centre for Evidence-Based Medicine; the Interdisciplinary Research in Health Sciences research group (which uses both quantitative and qualitative methods to examine the human, organisational and societal issues relating to the delivery of healthcare and the improvement of health services) and the Medical Sociology and Health Experiences Research Group (MS HERG), which undertakes qualitative research into the patient experience including the Healthtalk research programme published on CTU Head of Operations JD Final_Ly-Mee Yu.docx 4 www.healthtalkonline.org. The department is a founding member of the National Institute for Health Care Research (NIHR) School of Primary Care Research, houses both the NIHR Applied Research Collaboration (ARC), Oxford Thames Valley and the NIHR MedTech and In Vitro Diagnostics Co-operative (MIC), and leads several themes of the Oxford University Hospital BRC. In terms of methodologies, as well as our critical mass of social scientists and computer/information scientists, the department supports one of the largest groups of medical statisticians in medical sciences and a growing team of health economists. Clinicians in our department teach a number of threads in the undergraduate course in Medicine and we place students in GP practices as part of their training. We run a very successful, well established MSc programme in Evidence Based Health Care, and a new MSc in Translational Health Science with the Department of Continuing Education. In 2023 we will accept students to a new MSc in Applied Digital Health and to an MSc in Global Health Care Leadership run in partnership with the Said Business School. The University of Oxford is a member of the Athena SWAN Charter to promote women in Science, Engineering, Technology and Medicine and holds an Athena SWAN Bronze award at institutional level. The Nuffield Department of Primary Care Health Sciences holds a departmental Silver Athena SWAN award to recognise advancement of gender equality: representation, progression and success for all. The Nuffield Department of Primary Care Health Sciences currently holds a Gold National Union of Students (NUS) Green Impact award. Green Impact is an environmental accreditation scheme championed by the National Union of Students and is designed to support environmentally and socially sustainable practice. The department supports sustainability initiatives in the following areas: supporting and leading change; energy; water; materials and waste; sustainable travel; biodiversity and nature; and food. Our staff are mostly located in the superbly renovated Grade II listed Radcliffe Primary Care Building on the Radcliffe Observatory Quarter (ROQ), the University’s most prestigious development site for a generation, and close to the city centre (see http://www.ox.ac.uk/roq/ for more information). Some staff are located nearby in the Gibson Building at the ROQ and some, including clinical teachers are based in Eagle House nearby off Walton Street. Car parking is very restricted at both sites with only a small percentage of staff being granted an annual parking permit and priority being given to those with access needs. Bus Pass, Train Pass, bicycle loans and Season Ticket Loan Schemes are all in operation for staff. For more information please visit: http://www.phc.ox.ac.uk. Medical Sciences Division The Medical Sciences Division is an internationally recognised centre of excellence for biomedical and clinical research and teaching. We are the largest academic division in the University of Oxford. World-leading programmes, housed in state-of-the-art facilities cover the full range of scientific endeavour from the molecule to the population. With our NHS partners we also foster the highest possible standards in patient care. For more information please visit: http://www.medsci.ox.ac.uk/ How to apply Applications are made through our online recruitment portal. Information about how to apply is available on our Jobs website https://www.jobs.ox.ac.uk/how-to-apply. Your application will be judged solely on the basis of how you demonstrate that you meet the selection criteria stated in the job description. CTU Head of Operations JD Final_Ly-Mee Yu.docx 5 As part of your application you will be asked to provide details of two referees and indicate whether we can contact them now. You will be asked to upload a CV and a supporting statement. The supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience. This may include experience gained in employment, education, or during career breaks (such as time out to care for dependants) If you are applying for a research post and you have had periods of working part-time, please indicate this on your CV or in your supporting statement. This will ensure that any outputs such as publications are fairly judged when considered alongside the expected outputs of full-time workers. Where posts are advertised full-time, we may be able to consider part-time working or job share arrangements depending on the requirements of the role. If you want to work part-time and this option is not expressly stated in the advert or job information, please email hr@phc.ox.ac.uk to enquire whether the role you are applying for might be available on a part-time basis. Please upload all documents as PDF files with your name and the document type in the filename. All applications must be received by midday UK time on the closing date stated in the online advertisement. Information for priority candidates A priority candidate is a University employee who is seeking redeployment because they have been advised that they are at risk of redundancy, or on grounds of ill-health/disability. Priority candidates are issued with a redeployment letter by their employing department(s). If you are a priority candidate, please ensure that you attach your redeployment letter to your application (or email it to the contact address on the advert if the application form used for the vacancy does not allow attachments). If you need help Application FAQs, including technical troubleshooting advice is available at: https://staff.web.ox.ac.uk/recruitment-support-faqs Non-technical questions about this job should be addressed to the recruiting department directly please email recruitment@phc.ox.ac.uk To return to the online application at any stage, please go to: www.recruit.ox.ac.uk. Please note that you will receive an automated email from our online recruitment portal to confirm receipt of your application. Please check your spam/junk mail if you do not receive this email. Important information for candidates Data Privacy Please note that any personal data submitted to the University as part of the job application process will be processed in accordance with the GDPR and related UK data protection legislation. For further information, please see the University’s Privacy Notice for Job Applicants at: https://compliance.admin.ox.ac.uk/job-applicant-privacypolicy. The University’s Policy on Data Protection is available at: https://compliance.admin.ox.ac.uk/dataprotection-policy. The University’s policy on retirement The University operates an Employer Justified Retirement Age (EJRA) for very senior research posts at grade RSIV/D35 and clinical equivalents E62 and E82, which with effect from 1 October 2023 will be 30 September before the 70th birthday. The justification for this is explained at: https://hr.admin.ox.ac.uk/the-ejra. For existing employees on these grades, any employment beyond the retirement age is subject to approval through the procedures: https://hr.admin.ox.ac.uk/the-ejra. CTU Head of Operations JD Final_Ly-Mee Yu.docx 6 There is no normal or fixed age at which staff in posts at other grades have to retire. Staff at these grades may elect to retire in accordance with the rules of the applicable pension scheme, as may be amended from time to time. Equality of opportunity Entry into employment with the University and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation. Benefits of working at the University Employee benefits University employees enjoy 38 days’ paid holiday, generous pension schemes, travel discounts, and a variety of professional development opportunities. Our range of other employee benefits and discounts also includes free entry to the Botanic Gardens and University colleges, and discounts at University museums. See https://hr.admin.ox.ac.uk/staff-benefits University Club and sports facilities Membership of the University Club is free for all University staff. The University Club offers social, sporting, and hospitality facilities. Staff can also use the University Sports Centre on Iffley Road at discounted rates, including a fitness centre, powerlifting room, and swimming pool. See www.club.ox.ac.uk and https://www.sport.ox.ac.uk/. Information for staff new to Oxford If you are relocating to Oxfordshire from overseas or elsewhere in the UK, the University's Welcome Service website includes practical information about settling in the area, including advice on relocation, accommodation, and local schools. See https://welcome.ox.ac.uk/ There is also a visa loan scheme to cover the costs of UK visa applications for staff and their dependents. See https://staffimmigration.admin.ox.ac.uk/visa-loan-scheme Family-friendly benefits With one of the most generous family leave schemes in the Higher Education sector, and a range of flexible working options, Oxford aims to be a family-friendly employer. We also subscribe to the Work+Family Space, a service that provides practical advice and support for employees who have caring responsibilities. The service offers a free telephone advice line, and the ability to book emergency back-up care for children, adult dependents and elderly relatives. See https://hr.admin.ox.ac.uk/my-family-care Childcare The University has excellent childcare services, including five University nurseries as well as University-supported places at many other private nurseries. For full details, including how to apply and the costs, see https://childcare.admin.ox.ac.uk/ Disabled staff We are committed to supporting members of staff with disabilities or long-term health conditions. For further details, including information about how to make contact, in confidence, with the University’s Staff Disability Advisor, see https://edu.admin.ox.ac.uk/disability-support CTU Head of Operations JD Final_Ly-Mee Yu.docx 7 Staff networks The University has a number of staff networks including the Oxford Research Staff Society, BME staff network, LGBT+ staff network and a disabled staff network. You can find more information at https://edu.admin.ox.ac.uk/networks The University of Oxford Newcomers' Club The University of Oxford Newcomers' Club is an organisation run by volunteers that aims to assist the partners of new staff settle into Oxford, and provides them with an opportunity to meet people and make connections in the local area. See www.newcomers.ox.ac.uk. CTU Head of Operations JD Final_Ly-Mee Yu.docx 8
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