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Standard Grade 8: 45,585 - 54,395 with a discretionary range to £59,421 per annum (pro-rata)
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Department of Paediatrics, Oxford Vaccine Group, Churchill Hospital, Oxford
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173982 Senior Programme Manager Job Description.pdf
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_________________________________________________________________________ Job description and selection criteria Job title Senior Programme Manager Division Medical Sciences Department Paediatrics Location Department of Paediatrics, Oxford Vaccine Group, CCVTM, Churchill Hospital, Oxford Grade and salary Grade 8: £45,585 - £54,395 per annum (with a discretionary range to £59,421 per annum) Hours Full time Contract type Fixed-term (two years) Reporting to Emma Plested, Programme and Regulatory Affairs Director (UK) Vacancy reference 173982 Additional information Applications are to be made online, please see the advert for the closing date. The role The Senior Programme Manager will be based at the Centre for Clinical Vaccinology and Tropical Medicine and will provide oversight of the management of clinical trials or clinical programs. General areas of responsibility include: Management of Clinical Trial Assistants and Clinical Trial Support Officers; training and support of Project Managers, development and training of project management systems; provide oversight and knowledge to the research group; developing new policies and strategies with the group; sponsor liaison; project assessment and initiation; oversight of ethics and regulatory submissions; resource procurement and planning; project implementation; milestone planning and tracking; ensuring that projects are progressing according to contract and quality standards; SOPs, ICH-GCP, the UL Clinical Trial Regulations; production of key project progress reports; management of communication between the project team, sponsor, contract and financial management. Responsibilities Specific duties will include: a) Team Management • • • • • • • • To provide professional leadership and act as an accessible resource on clinical trial management keeping up to date with industry legislation and frameworks To be responsible for line management, staff appraisal and development of support staff, including Clinical Trial Assistants and Clinical Trial Support Officers, liaising with the Departmental HR Team. To train, support and guide Project Managers in project delivery To lead and facilitate a team of staff responsible for the coordination of a portfolio of clinical trials ensuring adherence to Standard Operating Procedures, ICH-GCP and other applicable guidelines To help set up and maintain good working practices and polices within the group, to determine when changes are required and oversee their implementation To establish and communicate team performance expectations and clear targets and project milestones To supervise the study team to ensure good lines of communication and strong working relationships are maintained both internally and externally To oversee the annual leave of staff members and ensure suitable cover during periods of staff absence to ensure studies are adequately covered b) Project coordination and management • • • • • Manage commercial or publicly-funded projects To develop and oversee new systems to track projects including all ethical regulatory review board information, patient recruitment activity and financial management in compliance with the study budget and University Financial Procedures. To have thorough knowledge of both the theoretical and practical aspects of the research studies To identify and participate in initiatives and developments relevant to the management and conduct of clinical trials Serve as primary contact to provide regular feedback, both written and verbal, to study Department of Paediatrics, Senior Programme Manager, Job Description 2 • • • • • • • • • • • • • • • • • Sponsors, Investigators (P.I & C.I), and the OVG Operations Manager, including project plans, project status reports and updates, or the study portfolio progress To contribute to and evaluate the study design, feasibility and logistics of proposed new studies and provide advice on regulatory requirements To assist with the preparation and review of all trial related documents including study protocols, patient information sheets, CRFs and other essential documents required to run the trial Be responsible for the oversight of ethics applications, submissions to the regulatory authority, and NHS Research and Development bodies To determine what project processes are needed, train and maintain project team knowledge, and apply the project processes To participate in the development of SOPs, guidelines, and group procedures and other continuous improvement programs and ‘lessons learned’ forums. To liaise with the Departmental Finance Team and Research Services to provide costings for all proposed studies, manage study budgets, and negotiate funding contracts with clients and third parties To ensure the planning, implementation, monitoring of all trials, ensuring progress and overall operational management is maintained To liaise with the Departmental Finance Team to ensure all administrative closeout procedures are completed across all studies Responsible for oversight of TMF management to ensure studies are inspection ready and regulatory compliant To proactively look for opportunities to accelerate recruitment and trial progress across study sites To advice on how to resolve issues that arise and to escalate in a timely and appropriate manner Contribute to the preparation of papers for publication, and prepare and present written and oral reports as required, including presenting at international meetings Work with the Quality Assurance Manager on any necessary audit processes Liaise with the IT Manager to ensure efficient and effective data management Maintain and regularly review financial records of all project expenses and oversee their payment by liaising with the Departmental Administrator and Departmental Finance Team. Support the lead nurse and/or clinical research fellow in the management of the project team to ensure timely and effective completion of project assignment Lead team meetings regarding the progress and delivery the study c) Supporting research team • • • • • • Make researchers aware of key relevant opportunities for new grant applications. Understand the clinical and research training needs of individual key research staff, and support them in meeting these needs Support the Principal Investigator in writing new grant applications Lead the evaluation of project activities, ensuring that lessons learned are integrated into future proposals Assist with recruitment, training and supervision of project team members as appropriate Report to the OVG Operations Manager any anticipated need for additional resources and Department of Paediatrics, Senior Programme Manager, Job Description 3 any needs or concerns regarding level of training or performance Selection criteria Essential • • • • • • • • • • • • • • Educated to degree level (or equivalent experience) in life science of health-related subject Ability to lead, support, motivate, delegate and line manage staff Ability to demonstrate initiative and think creatively to resolve problems, working both independently and part of a team Self motivation, and ability to work successfully and confidently to manage conflicting demands and tight deadlines Experience of developing new trials and writing and maintaining clinical documents Ability to manage mulitiple projects at various stages of development and organisation Extensive knowledge of Data Protection Act (1998), ICH GCP, GCLP, Research Governance and other key regulatory areas and ethical frameworks Excellent knowledge of regulatory and governance environment in the UK Experience of project management in a clinical environment Experience of writing reports and presenting complex information clearly Experience of creating study costings Evidence of effective organisational skills Excellent communication skills, both written and oral Well-developed interpersonal skills and the ability to work effectively with collaborators at all levels Desirable • • • Evidence of effective negotiation and facilitation skills Experience in audits Experience of working across the Higher Education / industry / NHS interface • Information technology skills, especially Microsoft Office software and e-mail 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 Department of Paediatrics, Senior Programme Manager, Job Description 4 Additional security pre-employment checks This job includes duties that will require additional security pre-employment checks: • A satisfactory basic Disclosure and Barring Service check due to the nature of this position, working with highly sensitive data. • University security screening (e.g. identity checks) Department of Paediatrics, Senior Programme Manager, Job Description 5 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 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 cuttingedge. 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. The University of Oxford has recently published their New Ways of Working framework to ensure professional service staff can continue to support the University’s academic mission whilst working on site or remotely. For more information, please visit https://hr.admin.ox.ac.uk/newways-of-working 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. Oxford Vaccine Group The Oxford Vaccine Group (OVG) is led by Andrew J Pollard, Professor of Paediatric Infection and Immunity. Staff are based within a purpose built centre on the Churchill Hospital site and form part of the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The aim of OVG is to co-ordinate expertise in the study of microbial diseases and the immune response to microbes, in order to facilitate research on the development and implementation of vaccines. This may include new, improved or combined vaccines for the adult and paediatric population. Core group members include 2 Consultants in Vaccinology, a Director of Clinical Trials, a Senior Clinical Trials Manager, adult and paediatric clinical research fellows, adult and paediatric research nurses, project managers, QA manager, IT manager, and an administration team. The Infection and Immunity Laboratory includes post doctorate scientists, research assistants and DPhil students. Wider group members include professionals from a range of specialities including immunologists, microbiologists, statisticians, a community paediatrician, the local Health Protection team and a bioethicist. Recent studies of the group include: • Pneumococcal conjugate vaccine studies in the elderly Department of Paediatrics, Senior Programme Manager, Job Description 6 • • • • • • Polysaccharide and conjugate quadrivalent meningococcal vaccine studies in adults H1N1 vaccine studies in children Pneumococcal nasopharyngeal carriage epidemiology Meningococcal B vaccine development Development of a typhoid challenge model COVID vaccines More information about OVG may be gained at the website: http://www.ovg.ox.ac.uk Department of Paediatrics The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology. Our work spans from early proof-of concept fundamental science, all the way up to its application in clinical settings. We continue to shape the landscape of medical science through positively impacting the lives of millions of children from our global research programmes, academic resources, and commitment to success. Our broad research base positions the department in a pivotal role and subsequently a world leader in child health. With research facilitates in the UK and abroad, we work on a global scale, building a paediatric network in the medical science community. We are committed to inform and inspire external audiences worldwide through our public engagement and outreach activities. In 2021, we successfully administered a grant value of £130,895,28 obtained through 168 projects. Our strong relationship with funding bodies have also been a contributor to the successes and milestones in children’s health research. With strong support from the Wellcome Trust, NIH, Cancer Research UK, UKRI, MDUK, Bill & Melinda Gates Foundation, Academy of Medical Sciences and the NIHR, we have employed 360+ staff, researchers, and students. These figures continue to grow as we expand our activities to overcome the multitude of challenges within children’s research health. For more information please visit: http://www.paediatrics.ox.ac.uk/ The Department of Paediatrics holds a silver Athena Swan award to recognise advancement of gender equality: representation, progression and success for all. Medical Sciences Division We are an internationally recognized 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: http://www.medsci.ox.ac.uk/ Department of Paediatrics, Senior Programme Manager, Job Description 7 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 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. 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) 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 https://staff.web.ox.ac.uk/recruitment-support-faqs advice is available at: Non-technical questions about this job should be addressed to the recruiting department directly at recruitment@paediatrics.ox.ac.uk or using the contact details in the online advertisement. 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 e-recruitment system to confirm receipt of your application. Please check your spam/junk mail if you do not receive this email. Department of Paediatrics, Senior Programme Manager, Job Description 8 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-privacy-policy. The University’s Policy on Data Protection is available at: https://compliance.admin.ox.ac.uk/data-protection-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. 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. Department of Paediatrics, Senior Programme Manager, Job Description 9 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 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. Department of Paediatrics, Senior Programme Manager, Job Description 10
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**About the role** The Oxford Vaccine Group, part of the Department of Paediatrics at the University of Oxford, is looking to recruit a Senior Programme Manager (SPM) to support UK clinical trials. The SPM will provide oversight of and leadership to the project management team, facilitating the successful set up, delivery and closeout of a portfolio of clinical trials. The Oxford Vaccine Group is part of a UKCRC registered clinical trial unit and is a centre for excellence for clinical trials of vaccines for the adult and paediatric population. Based at the Churchill Hospital we conduct studies aimed at reducing the worldwide toll of deaths and disabilities from major infectious diseases. With an embedded laboratory team and multiple collaborators across the world we are involved in the development and improvement of vaccines from early-stage preclinical work to late-stage post licensure studies. Please be aware, the University has introduced a pensionable Oxford University Weighting of £1,500 a year (pro rata) for all staff on grades 1–10 of the main salary and grading structure which will be implemented in the September 2024 payroll and backdated to 1 August 2024. Please follow the link here for further information on the outcomes of the recent Pay & Conditions review. **About you** The successful candidate must be educated to degree level (or equivalent experiance) in a life science or health-related subject with a current working knowledge of GCP, HTA, Research Governance, GDPR, and other key regulatory areas and ethical frameworks. You will have experience of project management in a clinical environment, including applications to regulatory authorities within the UK. This role requires a person with strong organisational and demonstrable leadership skills, experience in managing many complex projects and generating study costings with the ability to work with team members and collaborators at all levels. Significant experience in the management and development of staff is essential. The post is full-time for 1 year in the first instance. The role does require on site working at least 4 days per week, remote working can be facilitated one day a week. For further details regarding the role, please see the job description below. **Application Process** 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. Click here for information and advice on writing an effective Supporting Statement. To discuss the post in more detail, please contact Emma Plested, using the contact details below . Only online applications received before 12.00 midday on 19th August 2024 will be considered. Interviews will be held as soon as possible thereafter.
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About the role The Oxford Vaccine Group, part of the Department of Paediatrics at the University of Oxford, is looking to recruit a Senior Programme Manager (SPM) to support UK clinical trials. The SPM will provide oversight of and leadership to the project management team, facilitating the successful set up, delivery and closeout of a portfolio of clinical trials. The Oxford Vaccine Group is part of a UKCRC registered clinical trial unit and is a centre for excellence for clinical trials of vaccines for the adult and paediatric population. Based at the Churchill Hospital we conduct studies aimed at reducing the worldwide toll of deaths and disabilities from major infectious diseases. With an embedded laboratory team and multiple collaborators across the world we are involved in the development and improvement of vaccines from early-stage preclinical work to late-stage post licensure studies. Please be aware, the University has introduced a pensionable Oxford University Weighting of £1,500 a year (pro rata) for all staff on grades 1–10 of the main salary and grading structure which will be implemented in the September 2024 payroll and backdated to 1 August 2024. Please follow the link here for further information on the outcomes of the recent Pay & Conditions review. About you The successful candidate must be educated to degree level (or equivalent experiance) in a life science or health-related subject with a current working knowledge of GCP, HTA, Research Governance, GDPR, and other key regulatory areas and ethical frameworks. You will have experience of project management in a clinical environment, including applications to regulatory authorities within the UK. This role requires a person with strong organisational and demonstrable leadership skills, experience in managing many complex projects and generating study costings with the ability to work with team members and collaborators at all levels. Significant experience in the management and development of staff is essential. The post is full-time for 1 year in the first instance. The role does require on site working at least 4 days per week, remote working can be facilitated one day a week. For further details regarding the role, please see the job description below. Application Process 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. Click here for information and advice on writing an effective Supporting Statement. To discuss the post in more detail, please contact Emma Plested, using the contact details below . Only online applications received before 12.00 midday on 19th August 2024 will be considered. Interviews will be held as soon as possible thereafter.
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