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*THIS IS A RE-ADVERTISEMENT. PREVIOUS APPLICANTS NEED NOT APPLY* Oxford Population Health (Nuffield Department of Population Health) is home to world-renowned population health research groups and provides an excellent environment for multi-disciplinary research and teaching. The Clinical Trial Service Unit (CTSU) is a major international research institute within the NDPH, and is a world-leading centre for large-scale research into the causes, prevention and treatment of chronic diseases such as cancer and cardiovascular and kidney disease. As Clinical Trial Supplies Planner, you will contribute to the development of new methodologies and processes to improve the quality of current and future trials at CTSU, for example in relation to IMP management, forecasting and supplies. To be considered for the Clinical Trial Supplies Planner post, you will have a University degree, relevant experience within the procurement/supplies planning field, with proven success of delivering on agreed targets. You will also have excellent data management experience and the ability to work cohesively and effectively as part of a busy team with a high degree of accuracy. Ideally, you will have familiarity with the requirements of GMP, GDP and GLP, and experience working with third party suppliers and service providers. The post is full time (part time considered) and fixed term 2 years. The closing date for applications is noon on 26 March 2024. You will be required to upload a CV and Supporting Statement as part of your online application. The Supporting Statement should include a cover letter and should also clearly describe how you meet each of the selection criteria listed in the job description.
Oxford Population Health (Nuffield Department of Population Health), Old Road Campus, Oxford
Job description Job title Clinical Trial Supplies Planner Division Medical Sciences Division Department Oxford Population Health (Nuffield Department of Population Health, University of Oxford) Location Old Road Campus, Headington, Oxford, OX3 7LF Grade and salary Grade 7: £36,024 - £44,263 (with a discretionary range up to £48,350) Hours Full time (Part-time considered) Contract type Fixed term – 2 years Vacancy reference 171528 Clinical Trial Supplies Planner job description, March 2024 1 About Oxford Population Health Oxford Population Health (the Nuffield Department of Population Health) provides an excellent environment for multi-disciplinary research and teaching and for professional and support staff. We work together to answer some of the most important questions about the causes, prevention and treatment of disease. The Department has around 900 staff, students and academic visitors working in a number of world-renowned population health research groups, including the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), the Cancer Epidemiology Unit (CEU), the National Perinatal Epidemiology Unit (NPEU) and other groups working on public health, health economics, ethics and health record linkage. It is also a key partner in the Oxford University’s Big Data Institute. In the 2021 Research Excellence Framework (REF), 96% of the research submitted to Unit of Assessment 2: Public Health, Health Services and Primary Care, was ranked either 4* (world-leading in terms of originality, significance and rigour) or 3* (internationally excellent in terms of originality, significance and rigour). This comprised research from Oxford Population Health and research from the Nuffield Department of Primary Care Health Sciences. We scored particularly well for having an environment that is conducive to producing research of world-leading quality and enabling outstanding impact, in terms of its vitality and sustainability. In addition to its research activities, the Department is home to the MSc in Global Health Science and Epidemiology, the MSc in Clinical Trials, and a variety of short courses. Students also come to undertake research for DPhil degrees. Teaching is provided for undergraduates reading for Medicine and for public health doctors in specialist training. For more information please visit the Oxford Population Health website. About the Medical Sciences Division The Medical Sciences Division is an internationally recognised centre of excellence for biomedical and clinical research and teaching, and 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 the Medical Sciences Division website. 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 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 Clinical Trial Supplies Planner job description, March 2024 2 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 the Oxford University website. Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) CTSU is one of the world’s leading centres for research into the causes, prevention, and treatment of chronic diseases (such as cancer, renal and heart disease). The aim of the Unit is to generate and disseminate reliable evidence from observational epidemiology and from randomized trials that leads to practicable methods of avoiding premature death and disability. It has been responsible for initiating and conducting large-scale randomized trials of different treatments for some of the major diseases affecting public health, as well as establishing collaborative systematic overviews (“meta-analyses”) of individual patient data from randomized trials, particularly in cancer and vascular disease. It also plays an important role in large prospective epidemiological studies across the world, including in China, Cuba, India, Mexico, Russia and the UK. For more information please visit: www.ctsu.ox.ac.uk The role This is a key role relating to the supply of Investigational Medicinal Product (IMP) and the supply and retrieval of laboratory (typically blood and urine sample) kits to/from sites for the large-scale national and international trials run by the Clinical Trial Service Unit (CTSU). CTSU has extensive experience of developing efficient and streamlined clinical trials underpinned by extensive IT infrastructure. Since most of the studies for this Group are CTIMPs (Clinical Trial of an Investigational Medicinal Product), all processes must be in compliance with applicable regulations including the UK Medicines for Human Use (Clinical Trials) Regulations and its amendments and relevant EU directives relating to Good Clinical Pratice (GCP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). You will contribute to the development of new methodologies and processes to improve the quality of current and future trials at CTSU, for example in relation to IMP management, forecasting and supplies. Clinical Trial Supplies Planner job description, March 2024 3 Current trials include:       HPS-4/TIMI65/ORION-4: assessing inclisiran (a small interfering RNA which lowers LDL cholesterol) among people at high-risk of cardiovascular disease RECOVERY: a national platform trial assessing multiple interventions among people hospitalised with Covid-19 LENS: assessing fenofibrate among people with diabetic retinopathy ASCEND PLUS: a new national trial assessing the effect of semaglutide on cardiovascular and other outcomes in people with diabetes EASi-KIDNEY: a new international trial of participants with established chronic kidney disease that aims to definitively test the efficacy and safety of a novel aldosterone synthase inhibitor (ASi) BI 690517 given on top of standard of care Potential new studies Responsibilities  Responsible for key areas relating to IMP and laboratory sample kit provision to sites and sample retrieval both nationally and internationally  Assisting with the forecasting of laboratory sample kit requirements at Study, country and site level  Forecasting IMP requirements at site level and the provision of IMP to sites as required.  Assisting with planning and the procurement of laboratory sample kit components, kit manufacture and delivery of kits to sites depending on their current and projected requirements  Responsible for coordinating laboratory sample retrieval from sites. This may involve direct liaison with site staff, courier company’s and Central Coordinating Centre (CCO) Laboratory staff to coordinate sample shipments.  Management of spreadsheets to track samples requiring collection from sites  Responding to queries from the CCO Laboratory and Regional coordinating Office (RCC) staff regarding unexpected, missing or temperature compromised samples and managing associated spreadsheets  Contributing to SOPs and User Guides as required  Assisting with the management of IMP product complaints, and temperature excursions  Training junior staff as required on a day-to-day basis ensuring study operating procedures are adhered to and providing advice and solutions to any issues arising.  Establishing effective working relationships with a variety of stakeholders (including clinicians, site staff, couriers and third party suppliers) The above list is not exhaustive and the role-holder is required to undertake such duties as may reasonably be requested within the scope of the post. All staff are required to act in a professional, cooperative and flexible manner, in line with the requirements of the post. Selection criteria Essential  University degree or equivalent experience  Relevant experience within the procurement/supplies planning field Clinical Trial Supplies Planner job description, March 2024 4  Proven success of delivering on agreed targets  Ability to demonstrate a logical and analytical approach for developing processes and solving problems  Excellent data management experience  Familiarity with IMP supply, customs processes and logistics relating to IMP, kit and sample shipments  Ability to work with a high degree of accuracy  A high degree of proficiency in using Microsoft software including Excel and Access, or other tools used for forecasting and tracking of supplies, and Powerpoint  Ability to communicate clearly to ensure effective communication with colleagues, funders and third party providers, and to present written work clearly and concisely  Effective organisational and team working skills  Positive and flexible approach to meet the changing demands of the studies Desirable  University degree within a scientific discipline  Relevant experience within the procurement/supplies field in large-scale complex international clinical trials involving IMPs  Familiarity with GMP, GDP and GLP 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. How to apply Applications are made through our e-recruitment system and you will find all the information you need about how to apply on our Jobs website. Your application will be judged solely on the basis of how you demonstrate that you meet the selection criteria stated in the job description. 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 Clinical Trial Supplies Planner job description, March 2024 5 skills and experience. This may include experience gained in employment, education, or during career breaks (such as time out to care for dependants). Please upload your CV and supporting statement 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 illhealth/disability. Priority candidates are issued with a redeployment letter by their employing departments. 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 Help and support is available from the HR Systems Recruitment support webpage. If you require any further assistance please email the Recruitment Support team. To return to the online application at any stage, please go to the University’s recruitment website. Please note that you will receive an automated email from our e-recruitment system 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. The University’s Policy on Data Protection is available on the University’s Compliance webpages. 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. Clinical Trial Supplies Planner job description, March 2024 6 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. 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. Clinical Trial Supplies Planner job description, March 2024 7 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. 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. 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. There is also a visa loan scheme to cover the costs of UK visa applications for staff and their dependents. 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. 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 the Childcare Services webpages. 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 the Disability Support webpages. 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 on the Equality and Diversity at Oxford webpages. 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. 8
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***THIS IS A RE-ADVERTISEMENT. PREVIOUS APPLICANTS NEED NOT APPLY*** Oxford Population Health (Nuffield Department of Population Health) is home to world-renowned population health research groups and provides an excellent environment for multi-disciplinary research and teaching. The Clinical Trial Service Unit (CTSU) is a major international research institute within the NDPH, and is a world-leading centre for large-scale research into the causes, prevention and treatment of chronic diseases such as cancer and cardiovascular and kidney disease. As Clinical Trial Supplies Planner, you will contribute to the development of new methodologies and processes to improve the quality of current and future trials at CTSU, for example in relation to IMP management, forecasting and supplies. To be considered for the Clinical Trial Supplies Planner post, you will have a University degree, relevant experience within the procurement/supplies planning field, with proven success of delivering on agreed targets. You will also have excellent data management experience and the ability to work cohesively and effectively as part of a busy team with a high degree of accuracy. Ideally, you will have familiarity with the requirements of GMP, GDP and GLP, and experience working with third party suppliers and service providers. The post is full time (part time considered) and fixed term 2 years. The closing date for applications is noon on 26 March 2024. You will be required to upload a CV and Supporting Statement as part of your online application. The Supporting Statement should include a cover letter and should also clearly describe how you meet each of the selection criteria listed in the job description.
Clinical Trial Supplies Planner JD 171528
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Standard Grade 7: £36,024 - £44,263 (with a discretionary range up to £48,350)
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