Faculty of Medicine and Health School of Medicine Leeds Institute of Cancer and Pathology (LICAP) Section of Oncology & Clinical Research (Labs) Informatics Lead/Research Tissue Bank Transitional Manager (Administrative) A person is required to contribute to the development of a new integrated sample processing and biorepository in Leeds, whilst also providing administrative management to two of the existing Research Tissue Banks (RTBs) with joint governance and management structures. During the transition period whilst current activities are integrated, it is envisaged that the responsibility for certain RTB administrative management aspects will be shared with other members of the team. A major part of this role, initially and going forwards, will be as the Informatics Lead. As part of this the role will involve working with the MRC Bioinformatics Centre in Leeds to enable linkage of samples with high quality clinical data. You should have experience of successful project management in a biomedical research/clinical environment and a good working knowledge of aspects such as related ethics and regulatory/governance issues. Experience of designing, implementing and managing informatics systems and information flows and of working with a variety of database technologies and data formats is essential. Ideally this will include understanding of DBMS systems architecture and experience of administering and developing DBMS systems for the management of clinical, biological and clinical data. Experience in the tissue banking area specifically would be an advantage. You will be educated to degree level in a relevant subject area, possess excellent interpersonal skills, be confident interacting with people from a range of backgrounds and varying seniority and have proven experience of working effectively as part of a team as well as independently. This post is available immediately for a fixed term of two years in the first instance but may be extended subject to future funding and will be based primarily on the St James’s University Hospital campus in Leeds. The University of Leeds is committed to providing equal opportunities for all and offers a range of family friendly policies (http://hr.leeds.ac.uk/homepage/4/policies). The University is a charter member of Athena SWAN and holds the Bronze award. The School of Medicine gained the Bronze award in 2013. We are committed to being an inclusive medical school that values all staff, and we are happy to consider job share applications and requests for flexible working arrangements from our employees. University Grade 7 (£31,342 – £37,394) depending on qualifications and experience Informal enquiries regarding the post should be directed to Professor Roz Banks, email: r.banks@leeds.ac.uk. If you have any specific enquiries about your online application please contact Sharon Collins or Nicola Johnson: e-mail: s.collins@leeds.ac.uk or n.johnson@leeds.ac.uk Job Ref: MHCAP1019 Closing Date: 16 March 2015 The Leeds Institute of Cancer and Pathology (LICAP) Director: Professor Tim Bishop http://medhealth.leeds.ac.uk/info/900/leeds_institute_of_cancer_and_pathology The Leeds Institute of Cancer and Pathology addresses both laboratory based and clinical research into cancer with a major focus on translational science. LICAP is one of the largest cancer Institute’s in the country and has major financial support from the cancer charities. The laboratories and clinical research are all based on the St James’s site with laboratory activities being located in the Wellcome Trust Brenner Building and adjacent buildings while the clinical work is based within Bexley Wing. The Institute consists of eight Sections: Epidemiology & Biostatistics; Experimental Haematology; Experimental Oncology; Oncology & Clinical Research (Clinical); Oncology & Clinical Research (Laboratory); Patient Centred Outcome Research; Pre-cancer Genomics; and Pathology & Tumour Biology. Cancer Research UK Leeds Centre http://www.cancerresearchukcentre.leeds.ac.uk The Leeds Cancer Research UK Centre is a partnership between the University of Leeds, Leeds Teaching Hospitals NHS Trust and Cancer Research UK, which aims to harness the scientific power of Leeds-based cancer researchers to deliver improvements in cancer care at local, national and international level. It fosters excellence in basic and translational research and offers services to all cancer researchers in Leeds, irrespective of their funding source. Beyond research, the Centre is also keen to build stronger relationships with the local community, with patients undergoing cancer treatment, their carers, cancer survivors and the wider public. Section of Oncology and Clinical Research (Laboratory) – Professor Alan Melcher The Section’s research is centred on i) viruses as causative and therapeutic agents in cancer, ii) interactions between tumours and the host immune system (with a particular focus on the role of natural killer cells), iii) neuro-oncology, including glioma stem cells, the tumour microenvironment in brain tumours, and radiation biology and therapeutics, and iv) Identification of biomarkers and therapeutic targets in renal cancer and other diseases of the kidney, principally using proteomic techniques. The Section focuses particularly on translational research, spanning laboratory studies through to early clinical trials, to provide an iterative ‘bench to bedside and back again’ platform to develop novel treatments for cancer patients. Clinical and Biomedical Proteomics Group The Clinical and Biomedical Proteomics Group (www.proteomics.leeds.ac.uk) within the Section of Oncology and Clinical Research is led by Roz Banks, Peter Selby and Naveen Vasudev. Focussing on renal cancer and other renal diseases such as acute kidney injury and using predominantly proteomic-based approaches (complemented with collaborative genomic and epigenetic collaborations), our principal aims are to identify new disease biomarkers or novel therapeutic targets and also to increase our understanding of the underlying pathogenesis by examining the functional implications of our findings. We are also involved in a series of collaborative projects in other diseases. Background and Main Duties Bio-banking high quality tissue and fluid samples and collection associated clinical data is critical for many aspects of clinical and biomedical research, both within the Leeds Teaching Hospitals Trust (LTHT) and Faculty of Medicine and Health but also more broadly cross-Faculty. This ranges from basic through to translational research studies and includes support for clinical trials at GCP/GCLP level through provision of enhanced sample processing capabilities. Currently bio-banking for research under the Human Tissue Act (HTA) licence is organised through 4 local research tissue banks (RTBs; Breast, Vascular, Dental and Multidisciplinary which includes renal cancer, bladder cancer, neuro-oncology, colorectal cancer, ovarian cancers, benign urological diseases, renal transplantation, acute kidney injury and some neurological areas). Additionally one of the three multicentre Breast Cancer Campaign RTB hubs is located in Leeds, the coordinating centre, together with a multicentre NIHR Biomarkers RTB (renal and liver disease). Project-specific or trialspecific sample processing and collection are also strong features, particularly in areas such as musculoskeletal, cardiovascular, melanoma, GI pathologies and clinical trial activity linked to the Leeds Clinical Research Facility (CRF). A new initiative is aimed at building on the current excellent existing HTA-compliant RTB activities and integrating banking and sample processing activities into a unified activity in Leeds which will have many benefits including enhancing governance, sharing of best practice, increasing accessibility and cost-effectiveness. This will operate through the CRF infrastructure with GCP/GCLP operational performance to meet MHRA requirements and maintain HTA compliance, conforming with the governance structure of the joint LTHT/University of Leeds HTA Management Group. Through links with the MRC Bioinformatics Centre in Leeds, linkage of samples with high quality clinical data will be enabled. In addition to supporting biobanking for research and support to clinical trials, hosting of trial samples will be undertaken and sample-related services such as sectioning. This post will immediately start to contribute to the development of the new structures integrating such activities in Leeds, whilst also providing administrative management to two of the largest RTBs to ensure sustainability in the short-term. During the transition period and with development of the new organisational structures it is envisaged that the responsibility for certain RTB administrative management aspects will be shared with other members of the team, through existing external funding streams. One of the key parts of this role will be as the Informatics Lead of the Clinical Sample Banking and Processing Activities. The University and LTHT have mandated the use of Achiever Medical (provided through University IT) for bio-banking for research under HTA licence and this role will be responsible for liaising with the local Medical Achiever development team in the Faculty (with an evolving role in this area) to support the integration of bio-banking and sample processing activities into a unified activity. Main duties and responsibilities Playing a leading and evolving role within the team in the strategic development and integration of bio-banking and clinical sample processing into a cross-Faculty activity. Key administrative management aspects of existing activities (Leeds Multidisciplinary RTB, the NIHR Programme-related RTB and the joint RTB Management Committee) and developing activities are as listed below but several of these will be shared with other individuals within the team as it develops and roles evolve within the new structures. A key part of the role will be as the overall Informatics Lead in this area. Main responsibilities are to: Contribute and play an active lead role in developing and implementing a programme of work leading to the integration of banking and sample processing activities in the Faculty under one organisational structure following evaluation of the possible models. This involves all aspects from consent models to sample release. Continue to assess the bio-banking needs overall of the wider research/clinical community in Leeds and initiate developments which align with Faculty strategic priorities and internationally outstanding research. Responsible initially (until integration within the facility is complete) for the administrative management of the NIHR Programme-related RTB and the Leeds Multidisciplinary RTB and the joint Management Committee, arranging and reporting on meetings and undertaking any necessary actions to ensure their smooth operation and implementation of governance and access processes in compliance with ethical and regulatory requirements such as the Human Tissue Act (HTA). To extend this to aspects of management of the new integrated banking and processing RTB structure(s) going forward. Develop an understanding of the critical elements and the logistical issues to enable you, along with other management team members, to develop a long-term future plan for the effective operation of this resource. This includes exploring and mapping the cost framework of the banking and sample processing activities and developing a costrecovery model for the different stakeholders from academic to commercial, liaising with the financial managers in the Trust and University as necessary with the ultimate aim of achieving a sustainable activity. Maintain and develop further as necessary, systems to monitor the various areas of the bio-banks from recruitment through to utilisation of samples. Prepare reports, either verbally or written, for stakeholders to allow review of the activities. These may be local use only or for use in developing funding applications for example. Generate key performance indicators for sample-related activities and incorporate these into an analysis to develop and influence the strategy going forwards. Provide an effective communication link as part of the overall management team, between RTB Management Groups, the CRF, Trust/University management relating to HTA-related activities including the HTA Manager and the Designated Individual, the Persons Designate, and the clinical and sample processing teams to ensure that management decisions are robust and communicated and implemented effectively. Be an effective point of contact to respond to any internal or external queries. Possess and maintain a good up to date working knowledge of appropriate regulatory laws such as the Human Tissue Act (2004), guidelines such as the Medicine and Healthcare Products Regulatory Agency (MHRA) Good Clinical Practice Guidelines for Clinical Labs, and ethics issues in order to ensure compliance of the Programmes and the people involved. Ensure any changes are implemented as necessary to meet new requirements. Contribute to the development of processes and SOPs within the overall team to ensure ethical working with regard to using clinical samples, with particular responsibility for acquisition and governance issues related to clinical data in research (e.g. secure storage of patient data, checking consent restrictions, compliance with data protection legislation). Provide expert advice to staff and ensure new members are fully aware of relevant procedures and policies. Generate alerts to the groups as necessary and instigate, either individually or through upwards referral, corrective actions as necessary to ensure delivery and meeting of key targets Act as the Informatics lead on the integration of the existing bio-banking and sample processing activities and their related information systems into Achiever Medical through linking with the Achiever support team, and where appropriate, regional and national systems. Work with and support as required, the local HTA Management subgroup in identifying and prioritising system requirements for bio-banking (including Medical Achiever and consent systems) in consultation with all main stakeholders ensuring compliance with appropriate regulatory laws and University IT strategy. Contribute to the planning, resourcing and leading of projects to develop, integrate and enhance bio-banking information systems, in conjunction with Academic, IT and business management. Work with the Faculty and University IT service, LTHT Informatics and suppliers to resolve issues, improve system usage and services to support bio-banking systems (including Achiever Medical and consent systems). Work with the Leeds MRC Bioinformatics Centre Programme in ensuring through Exemplar 4 that the wider clinical and sample data needs and linkage to samples are met across all areas of the bio-banking activities to help meet the aims and objectives of the MRC centre. Liaise with LTHT Informatics team(s) on linkage and access to Trust systems either via the MRC Centre or directly as needed. Take responsibility for ensuring data linkage, information flows and informatics pipelines appropriate to these activities are developed and oversee their management going forwards. Oversee the maintenance and development of an effective website in terms of ensuring high quality and up to date outward-facing content. Work with a high level of independence and proactively prioritise the various tasks, responding flexibly to unplanned or unforeseen circumstances and answering queries/resolving complex problems with a wide range of people and processes. Use initiative and act independently to either directly coordinate or influence activities of multiple teams/people as needed, for example: i) liaising with technical teams to ensure samples are collected and logged and shipped in a compliant and timely manner, ii) meeting with activity Leads within the CRF to assess needs and then with senior staff in the Trust, Faculty and NHS R & D offices to integrate these plans within the wider strategy and influence/develop possible local funding initiatives. Be aware of and be proactive in reacting to international efforts and initiatives and any issues relating to bio-banking in the bigger context and be able to provide updates to management groups. Be able to interact and discuss funding priorities and strategic fit of bio-banking proposals with external organisations such as the MRC, Welcome Trust or EU. Lead with other management team members in preparing for actual audits/inspections by regulatory bodies such as the Human Tissue Authority and MHRA. Lead in submissions to the local research ethics committee (proposals and reports) and the development of patient information sheets and consent forms. Maintain awareness of, and apply University and other relevant Information Governance legislation and policies including the University Information Security policy and Use of Computer Systems Policy. Maintain strict confidentiality, and identify and escalate potential issues, including breach of data protection where appropriate Relationships You will initially be responsible on a daily basis to the academics currently leading developments in this area, Professors Roz Banks and Val Speirs, through whom you will be accountable to the Faculty Pro-Dean for Research and Innovation and ultimately the Dean of Faculty of Medicine and Health. For all informatics aspects of this role, you will be professionally accountable to the Faculty IT systems manager and be part of the Faculty and University IT team. You will work particularly closely with Professors Banks and Speirs, members of the clinical and sample processing teams including technical, data/operational management and QA staff, the Trust/University HTA Management Group and local Designated Individual, Persons Designated, CRF and MRC Bioinformatics Centre staff, as well as interacting with a range of internal and external clinical and scientific colleagues and stakeholders. University Values All staff are expected to operate in line with the university’s values and standards, which work as an integral part of our strategy and set out the principles of how we work together. More information about the university’s strategy and values is available at http://www.leeds.ac.uk/comms/strategy/ Person Specification Essential Educated to degree level in a relevant subject area Experience of working in medical/health-related areas with a good working knowledge of aspects such as related ethics and regulatory/governance issues and an enthusiasm for medical research Experience of successful project management and strategic initiative development in a biomedical research/clinical environment covering all aspects from scoping and ensuring strategic fit through costing to developing implementation strategies and output measures Experience of designing, implementing and managing informatics systems and information flows and of working with a variety of database technologies and data formats Understanding of DBMS systems architecture and experience of administering and developing DBMS systems for the management of clinical, biological and clinical data Possession of data management skills and demonstrated experience of working with complex datasets, including experience of data linkage, retrieval, integration and transformation and associated methods. Evidence of the ability to critically appraise, assess and engage at a high level with multiple stakeholders and potential funding bodies to ensure delivery of the future vision Able to write high quality scientific reports/summary documents for a variety of audiences A skilled communicator, able to demonstrate effective interpersonal skills, and be confident interacting with people from a range of backgrounds and varying seniority Evidence of ability to show a high level of self-motivation, personal organisation with the ability to prioritise time and workload and to work independently as well as within a team. Capable of liaising with and working effectively with health professionals and all members of the multi-disciplinary team across various levels and able to motivate people. Confident at interacting with senior professionals and members of the public and able to explain and present ideas concisely (verbally and written) and in an appropriate manner depending on the audience, from scientific to lay A high level of attention to detail, integrity and ethical awareness Willing to be flexible in the work pattern and to travel within the UK for short periods. Desirable A PhD in a biomedical area Experience of managing or being heavily involved with tissue banking Good working knowledge of aspects of financial management of projects Detailed knowledge of Trust/University systems such as Patient Pathway Manager and Medical Achiever Experience of linking clinical and research datasets with external datasets such as Registry data Knowledge of reporting systems and technologies (e.g. SQL Server Reporting Services) A working knowledge of Structured Query Language (SQL) and familiarity with other programming and scripting languages Faculty Information Faculty of Medicine and Health Information With more than 6,000 students, 1,600 staff and annual research income of £60m, the Faculty of Medicine and Health at Leeds is bigger than some universities. Leeds has one of the largest medical and bioscience research bases in the UK, and is an acknowledged world leader in cancer, cardiovascular, psychiatric, genetic, musculo-skeletal and health services research. Treatments developed in Leeds are transforming the lives of people around the world living with conditions such as HIV, TB, diabetes and malaria. The School of Medicine The School of Medicine at the University of Leeds is a major international centre for research and education. Our ambition is to improve health and reduce health inequalities, locally and globally, through excellent scientific research and the translation of that research into healthcare practice, and through the education of future scientific and clinical leaders who will advocate and practise an evidence-based approach. Our major strategic aims are to: Deliver outstanding research including basic discovery science through to applied health research that makes a significant difference to health. Produce exceptional graduates, clinicians, educators, doctoral and post-doctoral fellows whose learning has been informed and inspired by our research excellence and who will form the next generation of academic and clinical leaders. Develop and support knowledge transfer activities that flow from our academic activities. Create and maintain an efficient and sustainable environment for research and teaching within an organisational culture and management style that enacts and supports the university’s core values of community, inclusiveness, integrity and professionalism. The School of Medicine is organised into seven Institutes. All are committed to high quality research-led teaching, through their training of postgraduate research students, delivery of postgraduate taught courses, and its leadership in undergraduate teaching. The School works closely with the local NHS, having a number of jointly funded clinical posts to ensure this relationship is effective and strong for both research and student education. Terms and Conditions Details of the terms and conditions of employment for all staff at the university, including information on pensions and benefits, are available on the Human Resources web pages accessible via the links on the right hand side, or at http://hr.leeds.ac.uk/policies Disclosure and Barring Service Checks A Disclosure and Barring Service (DBS) Check is not required for this position. However, applicants who have unspent convictions must indicate this in the ‘other personal details’ section of the application form and send details to the Recruitment Officer Disabled Applicants The post will be based primarily on the St James’s University Hospital campus, Beckett Street, Leeds LS9 7TF. Disabled applicants wishing to review access to the buildings are invited to contact the department direct. Additional information may be sought from the Recruitment Officer, email disclosure@leeds.ac.uk or tel + 44 (0)113 343 1723. Disabled applicants are not obliged to inform employers of their disability but will still be covered by the Equality Act once their disability becomes known. Further information for applicants with disabilities, impairments or health conditions is available in the applicant guidance.