Important Job Application Information Thank you for your interest in NHS Tayside vacancies Please see below Job Description/Person Specification and General Conditions of Service Your Application Form must be completed in full. Please note copies of Curriculum Vitae, Qualifications and Course Certificates will not be accepted at this stage. Please return your completed Application Form to recruitment.tayside@nhs.net (quoting the vacancy reference number in the subject box) or to the postal address given on the General Conditions of Service. All completed applications are held in Human Resources until the closing date. After the closing date a panel will meet to prepare an interview shortlist. Once this decision has been made, all shortlisted applicants will be emailed to invite them to attend for interview. It is important that you check your emails regularly, including your junk/spam folder. This process takes approximately 6 weeks. Therefore, if you have not been contacted regarding interview within 6 weeks of the closing date, your application has been unsuccessful and you will receive no further correspondence from Human Resources. ADDITIONAL INFORMATION:Find out more about living and working in Tayside at: www.dundeecity.gov.uk www.angus.gov.uk www.pkc.gov.uk NHS TAYSIDE – AGENDA FOR CHANGE JOB DESCRIPTION 1. JOB IDENTIFICATION Job Title SCO6-5025N Department(s)/Location Tayside Medical Science Centre 1 Number of job holders 2. JOB PURPOSE This Research and Development Manager is a key appointment in Research Management and Governance in Tayside, having a strategic and operational role at local, regional and national levels. The job of the Manager is to provide strong leadership and vision within R&D; the post holder will devise and deliver a management and governance framework that creates a supportive and productive environment for clinical and translational science for the Tayside Medical Science Centre (TASC). The Manager is accountable to the Senior R&D Manager & Research and Development Director and will develop systems to deliver good governance, effective management, and budgetary rigour. The post holder will, in concert with the Senior R&D Manager & Research and Development Director, formulate and execute a Governance plan for the service. The post holder will have an important strategic role in developing and taking forward regional and national initiatives including links with other nodes of the Academic Health Science Centre and NHS Research Scotland, a body that delivers national R&D governance and management functions in which TASC is a key stakeholder. Key Roles: to work with the Senior R&D Manager & Research and Development Director: To integrate the activity of the R&D with the Tayside Clinical Trial Unit (TCTU) and the Clinical Research Centre (CRC), thus providing an effective research support framework for the TASC To provide management and oversight of R&D within TASC in collaboration with NHS Tayside (NHST) and the University of Dundee Research and Innovation Service. To facilitate the effective use of R&D infrastructure funding and delivery of research governance in accord with national standards and relevant legislation. To ensure implementation of policy decisions in relation to R&D across the Tayside AHSP. 3. ORGANISATIONAL POSITION Appendix 1. 4. SCOPE AND RANGE NHS Tayside provides area wide health services to a population of 400,000 as well as the population of North East Fife. In May 2014 University of Dundee and NHS Tayside established the Academic Health Science Partnership in Tayside (AHSP) to bring together the delivery of healthcare services, education, quality improvement and research with the purpose of improving the health of patients. Clinical research is undertaken by academic staff within the College, as well as staff of NHS Tayside. Many studies are performed in collaboration, utilising samples or data from NHS Tayside patients treated in hospitals, community services and in primary care. An increasing number of non-medical staff participates in research, particularly in research related to the delivery of health services, and Lifestyle. Tayside Medical Science Centre: The Tayside Medical Science Centre (TASC) formed in 2010 is a joint development of NHS Tayside and the University of Dundee to maximise their research potential and integrates, within a single operational framework, all aspects of research activity (including functions previously delivered by R&D; the Tayside Clinical Trials Unit and the Clinical Research Centre). TASC is the research component of the recently formed Academic Health Science Partnership in Tayside. TASC will develop research strategy for the two partners, and will ensure effective delivery of that strategy. TASC will have responsibility for managing the central funds derived from the Chief Scientist Office of the Scottish Government Health Directorate. The Dean of the School of Medicine directs TASC; the R&D Director of TASC provides leadership to the component functions of TASC described above via the integrated R&D Office. Each component function has an academic Lead. This post supports the R&D Director and Head of the Clinical Research Imaging Facility (academic lead) and provides focused and directed operational management. TASC Research and Development Services: The R&D office is located within the TASC Offices. The joint NHST/UoD TASC Office manages the infrastructure to support the Tayside AHSC. Role of the Manager: The appointee will manage some of the activity of the R&D Office depending on experience and expertise. TASC undertakes grant application and pre-award administration; risk assessment; governance and monitoring of research including clinical trials; financial administration; audit of outcomes; and the identification, protection and exploitation of intellectual property. Other staff include: R&D Governance Managers, Contracts Managers, Clinical trials co-ordinators, GCP Monitors, QA Monitor, Pharmacovigilance staff, IP staff, TCTU Directors and Assistant Directors, Business Development Managers, Softwear Developers, Data Information coordinator, Finance accountant and officer, Administrative Officers and A&C support staff. TASC staff also provide a service for researchers who collaborate with other Higher educational Institutes (eg, University of St Andrews) and Health Boards (eg, Fife). National dimensions: The manager will support the Senior R&D Manager & Research and Development Director, who has responsibility for managing the flow of information between NHS in Tayside and its strategic research partners, and the Chief Scientist’s Office in the Scottish Government Health Directorate. This is essential to ensure the continuing flow of R&D support funding from the Chief Scientist’s Office to the TASC in order to support clinical research, appropriate facilities and the use of NHS/UoD property and services in support of basic and clinical research. Client Groups and scale of activity: TASC staff (across all disciplines and at all levels), clinical and basic science academics and students, pharmaceutical industry and medical device companies and manufacturers (approximately 450) Active research projects across Tayside (approx 400): number of new projects per year (approx): 150, with a further 100 commercial projects, income from which is approximately £1M per annum for NHS Tayside. NHS Tayside Support for Science funding: £4.5M (2008-09) NHS Priorities and Needs Research Programmes: 9, to be reconfigured and replaced by Tayside AHSP stream AHSP's major partners: Internal: University of Dundee (in particular College of Medicine, Dentistry and Nursing (CMDN) and NHS Tayside. External: University of Abertay, Dundee; University of St Andrews; NHS Fife;, Scottish Diabetes Research Network (SDRN); Scottish Primary Care Research Network (SPCRN); Northern Scotland Cancer Research Network (NCRN); Scottish Medicines for Children Research Network (SMCRN); Scottish Stroke Research Network (SSRN); Scottish Mental Health Research Network (SMHRN); Scottish Dementia Research Network; Eastern Research Ethics Committees and , Scottish Health Innovations Ltd. Tayside is Lead Board for the Scottish Diabetes and Dementia Research Networks, whilst UoD CMDN is Lead partner for SPCRN. NHS Tayside is a research active NHS Teaching Board which, together with the College of Medicine, Dentistry and Nursing of the University of Dundee, forms the Tayside Node of the Scottish Academic Health Science Centre. The TASC carries corporate responsibility for the management of Research and Development throughout Tayside, to provide an integrated and streamlined service for all staff, regardless of employer or professional background. The TASC Office has responsibility for implementation of all aspects of research governance as outlined in the Research Governance Framework for Health and Community Care and relevant legislation including the Medicines for Human Use Regulations 2004. and as required by legislation through Medicines Healthcare Regulatory Authority (MHRA) in relation to clinical drug trials. This includes assurance of good clinical practice, pharmacovigilance, project monitoring and audit, dissemination of research findings and recommendations for progress from research into practice. The remit includes providing a 'one-stop shop' for clinical researchers to maximise research quality and opportunity for all groups of professional staff in collaboration with academic partners, while minimizing corporate risk: and focussing on future service needs. In addition, it incorporates the management of key service delivery units to maximise the development of quality research infrastructure and support quality research conduct, thereby minimising project-level risk. This includes working with the Tayside Clinical Trials Unit to develop standard operating procedures (SOPs) for research management and implementation of R&D policies and procedures on behalf of the TASC, monitoring research activity and reporting to appropriate bodies. TASC supports the following activities and services: Implementing the Tayside Academic Health Science Centre strategy, and supporting the TASC executive to inform future development of policy. Bidding for, managing and reporting on the R&D infrastructure funding received by NHS Tayside from CSO (£4.5M pa). Facilitating building and development of regional research networks, encouraging well-governed research collaborations and supporting management of state-of-the-art clinical research facilities. Supporting the activity of the TCTU/CRC; ensuring that the regulations defined by the MHRA are met. Implementing the Research Governance Framework for the Tayside AHSC Facilitating high quality, well managed research conforming to national set timelines for research approvals, including supporting and building systems which encourage a broad and dynamic research culture within Tayside Pre-award application advice and costings Contractual and business development management Intellectual Property management, and partnership working with SHIL Ensuring Investigators, College and NHS Tayside are fully compliant with all legal responsibilities associated with hosting Clinical Trials, and other clinical research Keeping up-to-date records of all research activity ongoing within NHS Tayside and the Tayside AHSC, liaising closely with support departments to report research activity levels and facilitate their full participation in R&D Managing commercial research with Pharma sponsors and funders, administering research income and ensuring financial probity Promoting and managing Tayside TMRC studies and the TMRC. Working with other HEIs in Tayside, Fife and beyond, and other NHS Health Boards to maximise effective collaboration in high quality research. The remit of RDS is to provide a 'one-stop shop' for clinical researchers, maximising research quality and opportunity, from pre-award advice to study management, whilst minimizing corporate and project–level risk. Its focus is on TASC strategy and priorities and on improving the health care delivery and outcomes for the population of Tayside and beyond. 5. MAIN DUTIES/RESPONSIBILITIES Clinical Research Governance The R&D Manager will be responsible for (depending on experience and expertise): Implementation of aspects of Research Governance across TASC as outlined in the Research Governance Framework for Health and Community Care and in line with scientific, regulatory and ethical best practice Development of appropriate monitoring arrangements for on-going activity Ensuring compliance with Good Clinical Practice throughout the research portfolio, with particular emphasis on activity for which the TASC is the nominated Sponsor and on clinical trials of investigational medicinal products Planning & Organisational Subject to agreement with the R&D Director/Senior R&D Manager, autonomy over Tayside Medical Science Centre (TASC) training programme to identify training gaps across the whole of Tayside, and provide training solutions; liaise with internal/external groups to secure training solutions. Support the TASC Executive and the R&D Director by making sure that underpinning training requirements are completed timeously and effectively to ensure scientific, ethical and regulatory integrity of Tayside research. Prioritise own workload in order to organise the training diary for a minimum of 12 months ahead; draw up training timetables for Tayside researchers. Use networking skills to keep in touch with support staff who will deliver training. On a day to day basis, identify and collate information that will inform future development of the TASC training programme. Coordinate across different sections of TASC; organising and planning for the different needs and requirements. Attend regular meetings and maintain regular email contact with different sections of TASC and key research groups. Act upon urgent training needs using own initiative and if necessary make an immediate response. Develop a registration system for recording training course bookings and recording attendance for audit by regulators. Patient/Client Care No specific involvement in patient care, but will assist and redirect patients, carers and relatives who inadvertently arrive at the TASC office/event. Policy & Service Developing and implementing policies in support of SOP training, regulatory compliance, and ethical integrity for TASC R&D Staff and Tayside researchers. Lead role in annual development of training timetable. Provision of reports as required, by auditors or regulatory authorities. Response to research strategy set by the TASC Executive/TASC Board. Contribution to the national training programme in Scotland, and link person to Clinical Research Training Scotland. Financial Resources Responsible for managing a training budget of up to £20,000 per annum. Responsible for securing best value for training services delivered by third parties, and managing costs of training materials, venues, etc. Forming links with internal and external groups and organisations to share expense of training and ensure best value for money. Human Resources Induction activity for new TASC R&D staff. Provide advice and demonstrate own activities or workplace routines to new or less experienced colleagues. Manage training activity of peers as a functional activity area. Managing staff in the absence of other managers within TASC R&D (matching cover). Information Resources Responsible for development and maintenance of the TASC resource centre, incorporating paper based and electronic information resources for TASC R&D staff and Tayside researchers. Development of online information resource containing training materials for TASC R&D staff and Tayside researchers. Ongoing development and maintenance of existing mini-GCP (Good Clinical Practice) online learning course. Freedom to Act Make training recommendations to the Senior R&D Manager and the R&D Director. Act upon own initiative. 6. COMMUNICATIONS AND RELATIONSHIPS Internal communications: frequent and regular communication with R&D Managers, members of the TASC executive, and senior clinical and laboratory researchers. He/she will have a key role in communication with staff working in the TCTU. External communications: Other HEI research partners; Scottish Government Health Directorate/Chief Scientist Office; R&D Directors of other NHS Boards, Trusts and Hospitals throughout UK; Scottish Health Innovations Ltd; Translational Medicine Research Collaborative; Translational Medicine Research Initiative Limited. Relationships: The post-holder must: - Be an excellent communicator (oral and written), who is able to interpret and relate complex information - Be able to participate in at senior and executive level meetings, providing reliable input and identifying issues, which need to be taken forward. 7. KNOWLEDGE, TRAINING AND EXPERIENCE REQUIRED TO DO THE JOB Essential knowledge, training and experience: • Clinical researcher with extensive research experience • Considerable understanding and experience of service provision of all scientific, regulatory and ethical aspects of clinical research, together with operational and line management experience, • Previous research management experience inside or outside the NHS or Universities • Detailed knowledge of Research Governance Framework for Health and Community Care, Medicines for Human Use (Clinical Trials) Regulations, Adults with Incapacity (Scotland) Act, Data Protection Act, Governance Arrangements for Research Ethics Committees, Human Tissue Act. • Leadership qualities and proven ability to work effectively as part of a team, but also self-motivated and able to work independently when necessary • Good IT skills (including the use of Access databases) • Experience of working to Standard Operating Procedures • Trained in ICH GCP (Good Clinical Practice) Preferred knowledge, training and experience: • Postgraduate degree (eg MSc, PhD, MD) and appropriate clinical or health sciences qualification (e.g. membership of a Royal College or equivalent) • Industrial experience in healthcare R&D. • Experience of FDA or MHRA inspection/audit • Experience of management with a CTU or clinical research facility Induction Standards & Code of Conduct Your performance must comply with the national “Mandatory Induction Standards for Healthcare Support Workers in Scotland” 2009; and with the Code of Conduct for Healthcare Support Workers. ESSENTIAL ADDITIONAL INFORMATION 8. SYSTEMS AND EQUIPMENT The post holder will develop a good understanding of the SReDA database and other relevant local databases (e.g. RIS, pharmacovigilance), in order to provide a quality service to researchers for single and multi-site and NRS studies, and use standard computer word processor, database, spreadsheet and communication packages. Electronic data storage e.g. Word, Access, Excel, PowerPoint used for obtaining, inputting, searching, updating and producing information for dissemination locally, nationally and internationally. Oversee development of Policies, Standard Operating Procedures, and Work in Practice documents relating to R&D management, their review, update and implementation of new policies and procedures Physical Skills Keyboard and IT (advanced skills for innovative training materials), working to strict timetables and deadlines. Responsibility for transporting and safe assembly and dismantling of equipment. RESPONSIBILITY FOR RECORDS MANAGEMENT All records created in the course of the business of NHS Tayside are corporate records and are public records under the terms of the Public Records (Scotland) Act 1937. This includes email messages and other electronic records. It is your responsibility to ensure that you keep appropriate records of your work in NHS Tayside and manage those records in keeping with the NHS Tayside Records Management Policy and with any guidance produced by NHS Tayside specific to your employment. 9. PHYSICAL DEMANDS OF THE JOB • Physical - Combination of sitting, standing and walking required. • Mental - frequent requirement for prolonged intense concentration e.g. reading complex documentation and management meetings, with frequent interruptions of an unpredictable nature and changing priorities requiring rapid adaptation to accommodate the changing demands of NHS Tayside, the university sector, the commercial sector and central government. • Emotional - periodic requirement to direct staff to change some aspect of work procedures or prioritise workload. This will occasionally involve confronting staff with issues they do not agree with and the need to overrule them. Occasionally need to challenge medical or executive opinions. Very occasional exposure to distressing or emotional circumstances • Environmental - Frequent use of VDU; regular travel to sites across the Tayside AHSC and other NHS organisations in Scotland 10. DECISIONS AND JUDGEMENTS The post holder has responsibility, with other Managers, for implementing the Tayside AHSC strategy in relation to R&D, and ensuring effective implementation of R&D policy agreed with the Board; The post holder is responsible to the Senior R&D Manger and R&D Director working with the Dean of Medicine for activity of TASC. Electronic data storage e.g. Word, Access, Excel, PowerPoint used for obtaining, inputting, searching, updating and producing information for dissemination locally, nationally and internationally. Online scientific and medical literature archives, e.g. PubMed Standard Operating Procedures and Working Instructions relating to R&D management, their review, update and implementation of new policies and procedures. The post-holder will: Make complex decisions on cost allocations to departments and services which contribute to improvements in the quality and nature of research activity Provide expert scientific and managerial input to R&D meetings Provide guidance to investigators on Research Governance, involving interpretation of complex policy and legislation Manage his/her time effectively to meet competing demands, ensuring that work is prioritised and that outcomes are delivered timeously 11. MOST CHALLENGING/DIFFICULT PARTS OF THE JOB o o Adapt to a constantly and rapidly changing environment at local and national levels and influenced by changing national policies and regulations. Make complex judgments based on expert and wide-ranging knowledge and interpretation of specific situations. Ensure high-quality research receives a high profile and increase funding of research support in the Region.Adapt to a continually changing and evolving environment at local and national levels, influenced by changing national policies and regulations.In addition to those already described a high degree of forward planning skills. Frequently exposed to highly confidential, complex and sensitive information that must not be divulged inappropriately. Requirement to accommodate and respond to personal dynamics and the politics of working within a complex organisation. Able to respond to occasional verbal aggression from staff or visitors in a calm and controlled manner. Portray a positive and enthusiastic image at all times. Have the confidence to act without support. PERSON SPECIFICATION POST REF NO: P/EB/22 JOB TITLE/BAND: RESEARCH AND DEVELOPMENT MANAGER – IMAGING – BAND 7 LOCATION: TAYSIDE MEDICAL SCIENCE CENTRE (TASC), NINEWELLS HOURS: 37.5 HOURS PER WEEK CRITERIA EXPERIENCE: ESSENTIAL Extensive previous clinical Experience of working in a research experience or clinical multi-disciplinary team research support experience would be an advantage, as within a University, NHS or would familiarity with the Industry challenges faced by other professions. Proven ability and experience of line management and leadership within the public or private sectors. Experience of operational management of a research support function Direct research experience is also essential gained either through experience as a researcher, or in research administration QUALIFICATIONS: (Training; Research; Publications) DESIRABLE The post holder should be educated to degree level preferably in a scientific or business discipline and / or have extensive experience gained working with research professionals in an appropriate environment Trained in GCP (Good Clinical Practice) KNOWLEDGE & SKILLS: Knowledge of UK Clinical Trial Regulations, EU legislation, ICH guidance, EudraLex Volume 10. Also, detailed knowledge of Research Governance Framework for Health and Community Care, Adults with Incapacity (Scotland) Act, Data Protection Act, Governance arrangements for Research Ethics Committees, Human Tissue Act Highly developed current specialist knowledge of the pharmaceutical industry and the NHS environment. Strong communication skills including the ability to work with and influence senior staff and develop and maintain effective collaborative relationships Ability to prioritise own workload, and plan and manage multiple projects Excellent written skills and an ability to interpret, summarise and communicate complex information A high level of accuracy and attention to detail as well as sound planning and organisational skills Computer literate Microsoft Word, PowerPoint and Excel PERSONAL QUALITIES: OTHER: (eg travel across Tayside) including Access, Proven ability to work as part of a team and collaborate with others. Able to work independently and efficiently with a high degree of flexibility. Ability to cover for other Managers absence . General Conditions of Service POST REF NO: P/EB/22 JOB TITLE/GRADE: Research & Development Manager, Imaging – Band 7 LOCATION: Tayside Medical Science Centre, Ninewells Hospital CONDITIONS OF SERVICE Remuneration Hours of Duty Superannuation The terms and conditions of service for this post are those determined by the NHS Staff Council. The current salary scale for the post is £ 31,383 to £41,373 per annum (pro rata for part-time staff). Placing on the scale on appointment is normally at the minimum but may be higher subject to verification of previous relevant service. Salary is paid Monthly by Bank Credit Transfer. The hours of the post are 37.5 per week. Start and finish times will be determined by the needs of the service. Membership of the NHS Superannuation Scheme is not compulsory but is open to all staff between the ages of 16 and 70 (65 in some instances). The contributions paid are a percentage of superannuable pay, which is essentially basic pay excluding, for example, overtime or travelling expenses. Contribution rates with effect from 01.04.15 are as follows: Annual Pensionable Pay (Full-time equivalent) Up to £15,828 £15,829 to £21,601 £21,602 to £27,089 £27,090 to £49,967 £49,968 to £71,337 £71,338 to £111,376 £111,377 and over Annual Leave Contribution 5.2% 5.8% 7.3% 9.5% 12.7% 13.7% 14.7% Contributions are subject to tax relief and reduced National Insurance contributions. NHS Tayside also makes a substantial contribution towards scheme benefits – currently around 14% of basic pay. On appointment = 27 days (pro rata for part-time Staff) or 5.4 weeks per year. After 5 years aggregated service = 29 days (pro rata for part-time staff) or 5.8 weeks per year After 10 years aggregated service = 33 days (pro rata for parttime staff) or 6.6 weeks per year Public Holidays = 8 days (pro rata for part-time staff) or 1.6 weeks per year References Occupational Health Clearance Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003 Disclosure Scotland Immigration, Asylum and Nationality Act 2006 All offers of appointment are subject to receipt of two satisfactory references. All offers of appointment to new entrants to the National Health Service are subject to a medical examination. Medical examinations are arranged and undertaken by the Occupational Health and Safety Advisory Service (OHSAS). All current or spent criminal convictions, cautions, warnings or any case pending must be disclosed prior to commencing in employment as detailed on the application form. Please note that having a conviction will not automatically debar you from obtaining employment with NHS Tayside. Careful consideration will be given to the relevance of the offence to the particular post in question. However, if you are appointed, and it is found that you did not reveal a previous conviction your employment may be terminated. This post is subject to a Standard check by Disclosure Scotland as it involves access to children and/or vulnerable adults. This will contain details of any convictions on record whether spent or unspent. It is a criminal offence for an employer to employ anyone who does not have permission to live or work in the UK. Shortlisted applicants will be asked to produce specific original documentation at interview e.g. Passport, or full birth certificate together with an official document giving the applicants permanent National Insurance Number and name issued by a Government Agency or a previous employer, as well as photocopies of these documents. Professional Registration/ New entrants to NHS Tayside will be required to achieve the Induction Standards & mandatory Induction Standards for Healthcare Support Workers Code of Conduct (HCSWs) in Scotland and comply with the Code of Conduct for HCSWs throughout your employment. Smoking Policy Applications Internal candidates will be required to comply with the Code of Conduct for HCSWs. NHS Tayside operates a No Smoking Policy and smoking is prohibited within NHS premises and grounds. Completed forms should be returned to: recruitment.tayside@nhs.net quoting the job reference in the subject line or to Human Resources Directorate, Management Offices, Perth Royal Infirmary, Taymount Terrace, Perth PH1 1NX By closing date of Thursday, 23 July 2015 University of Dundee Court TAHSC Board UofD: Principal VP Dean, Medicine Head of Planning, CMDN NHS Tayside: CEO COO Finance Director NHS Tayside Board SAHSC National Oversight Board Rapid Response Group Research strategy of TAHSC Node Research Governance MHRA Inspections National Targets and Opportunities Financial Oversight Development of Research Portfolio TAHSC Executive Group Scientific Steering Committee Implementation of strategy Operational Management Financial Governance Research Governance Committee Chair: Margaret Smith Chair: Allan Struthers Research Governance Networks/Speciality Groups TAHSC Operational Managers Team R&D office Governance Approvals Risk Assessment BDM/Commercial Legal IP Finance/Costings CSO Liaison Chair: James Ferguson Imaging Clinical Trials Unit Collaboration CRC/Training & Staff Quality Assurance Audit Standards Pharmacovigilance IMP Handling Biorepository/ Tissue Bank NHS Academics Committee Trial Management Data Management (in collaboration with Health Informatics Centre & Dundee Epidemiology & Biostatistics Unit)