Research Delivery Directorate

Head of Feasibility and Study Start Up

The National Institute for Health Research Clinical Research Network Coordinating Centre is a hosted organisation provided through a partnership of:

•Guy’s and St Thomas’ NHS Foundation Trust

•Imperial College London

•King’s College London

•Newcastle University

•PA Consulting Group

•University of Leeds

•University of Liverpool

National Institute of Health Research, Clinical Research Network Coordinating Centre Faculty of Medicine and Health/Guy’s and St Thomas’ NHS Foundation Trust

Head of Feasibility and Study Start Up – 1.0 FTE

Leeds or London based

This post is available fixed term until 31 March 2020

You will have responsibility for the leadership, management and continuous improvement of the services that the NIHR CRN deliver to support study feasibility and start up in the NHS in England. This will involve leading substantial project work to maximise engagement, efficiency and the quality of the services for all clinical research supported by the CRN, across our substantial commercial research portfolio including non-commercial, collaborative and commercial studies. . Working closely with funders of research (life sciences industry, charities, funding bodies) and stakeholders, you will develop and foster positive relationships to ensure that research is set up as efficiently as possible, to maximise delivery and opportunities for people to access clinical research opportunities within the NHS.

You will be a dynamic and inspirational leader with the ability to drive continuous improvement in services, delivered within a matrix managed Network across England. This will be achieved through driving the collective leadership of the Research Delivery Management community, which includes the Local CRN Industry Operations Managers, Research Delivery Managers Study Support Service managers and key roles within the CRN co-ordinating centre.

Elements of the CRN Working with the Life Sciences Industry strategy and the CRN Research Delivery strategy related to early contact and engagement, feasibility and study start-up will be led by you. The vision for improving end to end delivery of clinical research through the CRN will be overseen by the RDD leadership team, which includes the Research Delivery Director, the Head of Divisional Research Delivery, the Head of Research Operations and the Head of Feasibility and Study Start Up.

You will report to the Research Delivery Director and will play an important leadership role within the CRNCC Research Delivery Directorate, deputising for the Research Delivery Director as appropriate. You will be directly responsible for a team of eight individuals supporting operational delivery of feasibility services and oversight of start-up activities. Delivery of this role will require excellent influencing and leadership skills and will develop and foster effective relationships with our Customer and Stakeholders involved in delivering research within the NHS.

The University of Leeds is committed to providing equal opportunities for all and offers a range of family friendly 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 9 (£48,327 - £55,998 p.a) depending upon qualifications and experience

Informal enquiries should be directed to Dr Clare Morgan, Research Delivery Director, or 0113 343 0331

General enquiries regarding your online application should be directed to Claire Porteus, HR Assistant, or 0113 343 0438

Job Ref: MHNCC1067Closing Date: 14 December 2016

MAIN DUTIES AND RESPONSIBILITIES

The job description provides a framework for the role and should not be regarded as a definitive list of duties and responsibilities, which will develop and change over time through natural progression.

  • Lead a national programme of work focused on NIHR CRN Study start up initiatives, processes and best practice; encompassing study and site feasibility, risk assessments, costing and contract negotiation through to ‘ready to recruit’ status. This is a rolling programme and will require continuous monitoring, evaluation and change management. This role covers the entire NIHR CRN Portfolio, including both commercial and non-commercial research and is multifaceted.
  • Provide leadership for partnership working with key customers and stakeholders to identify opportunities, benefits and ways of engaging with the NIHR CRN and continuously improving the setup of research in the NHS. These will include, but are not limited to, the Department of Health, HRA, MHRA, Funders (life sciences industry, charities, funding bodies), AMRC, trade associations, offices of the UK Devolved Administrations, NIHR infrastructure, CTUs and the CRN, research institutions and individual researchers.
  • Project manage delivery and implementation of the NIHR CRN life sciences industry strategy in relation to feasibility and start up elements, to ensure Industry Customer requirements are being met in line with defined timelines for implementation.
  • Oversee the performance and service timelines for NIHR CRN start up services. This is currently predominantly for commercial contract research but services for non-commercial research will be developed and established.
  • Develop an annual business plan for Feasibility and Study Start Up with the Research Delivery Directorate, performance managing work programmes, reporting progress against plan, risk assessment and management and resource management.
  • Convene and lead national NIHR CRN research delivery management related meetings.
  • Support the LCRNs to develop and implement local strategy to deliver performance and service improvements in relation to delivery of the Study Support Service.
  • Work with the NIHR CRN Research Delivery Management community to identify examples of best practice for effective set up of research facilitating innovative methods to share and implement these across the NIHR CRN, at both a local and national level.
  • Ensure that the NIHR CRN services for Customers is responsive and meets both its needs and the evolving clinical research environment.
  • Responsible for improving performance of the CRN High Level Objectives related to study start up (HLO 4 and 5), with effective Business Intelligence and use of our data assets.
  • Monitor communications and training requirements for Network staff, customers and stakeholders to ensure optimum understanding of both parties’ requirements is understood; implementing changes when required.
  • Performance manage the CRNCC Feasibility and Start Up team, with collective leadership accountability for the Research Delivery Management community, which includes the Local CRN Industry Operations Managers, Research Delivery Managers and Study Support Service Managers.
  • Work with the Research Delivery Management community, to lead programs of work in order to streamline and optimise processes for feasibility and study start up at local level.
  • Work with the Head of Divisional Research Delivery to lead programs of work in order to streamline and optimise complementary processes for study delivery and performance at national level.
  • Work with the Heads of Business Development and Marketing to ensure that strategy and plans for engagement dovetails with effective set up of clinical research by the NIHR CRN.
  • Raise awareness about the role of the NIHR CRN and improve understanding about research networks, clinical trials and their management through the representation of the NIHR CRN Coordinating Centre at meetings, contributing to reports and other publications, delivery of presentations as appropriate and responding to general queries.
  • Maintain relevant national costing tools and support processes in line with AcoRD guidance.
  • Maintain responsibility for own professional development by keeping up to date with relevant policy and key professional issues so as to be able to inform NIHR CRN colleagues and national debate as required.
  • Undertake any ad hoc initiatives as required by the CRNCC Executive Team.

PERSON SPECIFICATION

Essential

  • Educated to degree or equivalent level in a relevant subject area, e.g. health sciences, nursing.
  • Proven leadership experience in managing national programmes of clinical trial delivery.
  • Ability to work autonomously to make rapid and considered decisions which have national impact.
  • Experience of developing and delivering national strategy and programme management;
  • A strategic thinker with an ability to be hands on and highly results orientated.
  • Experience and skills in key performance indicators related to clinical research.
  • An understanding of the UK clinical research environment, including NHS structures and the NIHR CRN.
  • Understanding of funding and costing requirements and processes for clinical trials in the NHS.
  • Strong consumer focus with proven ability to build strong networks both internally and externally.
  • Ability to conceptualise, articulate and communicate persuasively about complex ideas.
  • Ability to command the respect of, and operate effectively with senior individuals from professional bodies, government, academia, the NHS and Industry.
  • Evidence of working to key performance targets and delivering to these using management tools and skills.
  • Strong project planning and analytical skills.
  • Leadership and responsibility for major initiatives, with experience of delivering results in complex and difficult situations for a variety of competing stakeholders.
  • Experience of delivering projects linked to an organisation’s strategic agenda.
  • Strong leadership skills and ability to effect change.
  • Strong diplomatic, influencing and negotiating skills.
  • Well-developed people management skills, including detailed experience of setting objectives and performance management.
  • Ability to manage change and work effectively in a rapidly evolving environment.
  • Ability and willingness to travel frequently, with overnight stays within the UK and occasionally overseas.

Desirable

  • Training in Continuous Improvement Methodology, for example LEAN or SIX SIGMA.

BACKGROUND INFORMATION

NIHR Clinical Research Network

The National Institute for Health Research (NIHR) Clinical Research Network (CRN) makes it possible for all patients and health professionals across England to participate in relevant clinical trials. We provide the infrastructure that allows high-quality clinical research to take place in the NHS, so that patients can benefit from new and better treatments. We also help researchers to set up clinical studies quickly and effectively, we support the life-sciences industry to deliver their research programmes, we provide health professionals with research training and we work with patients to ensure their needs are at the very centre of all research activity. With annual funding of £300m and a portfolio of some 6000 clinical studies, we provide a workforce of several thousand embedded NHS staff, supported by streamlined, effective and efficient operational systems, to support the delivery of research in all clinical specialties in all NHS sectors. The NIHR CRN is formed of 15 Local Clinical Research Networks (LCRNs) that provide coverage of the whole of England, and our portfolio of studies is organised in 30 clinical research Specialties.

The NIHR CRN Coordinating Centre (CRNCC) provides national coordination and oversight of the CRN, which includes development and implementation of national CRN strategies, policies, systems, processes, frameworks and standards, and support and performance management for the LCRNs and CRN Specialties.

The Coordinating Centre is a hosted organisation jointly managed by the University of Leeds and Guy’s and St Thomas’ NHS Foundation Trust (“the CRNCC Consortium”). Some specific activities are provided by a broader Alliance of partners that includes Newcastle University, the University of Liverpool, Kings College London, Imperial College London, and PA Consulting Group.

For further information about the NIHR Clinical Research Network, please visit our website:

National Institute for Health Research

The NIHR Clinical Research Network is a key element of the National Institute for Health Research, which is funded through the Department of Health to improve the health and wealth of the nation through research. The NIHR is a large, multi-faceted and nationally distributed organisation. Together, NIHR people, facilities and systems represent the most integrated clinical research system in the world, driving research from bench to bedside for the benefit of patients and the economy.

Since its establishment, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research.

Further information on the National Institute for Health Research can be found at:

University of Leeds

The University of Leeds is one of the UK’s largest, most prestigious and diverse research-intensive universities. Ranked amongst the world’s top 100 universities in the QS World rankings, and a member of the Russell Group of leading research universities, the University has an annual turnover of £587 million, over 31000 students and 7500 staff. It is now embarking on an exciting and critical period in its development, making significant investments in its infrastructure and research capability as part of a new strategic plan.

The CRN CC is hosted within the Faculty of Medicine and Health. The Faculty is at the forefront of cutting edge discovery science and translational clinical research and has a broad portfolio of programmes of study, training tomorrow’s healthcare and medical professionals. With around 1600 staff and more than 6500 students it is the largest faculty in the University of Leeds, and is one of the largest medical faculties in Europe.

Guy’s and St Thomas’ NHS Foundation Trust

With an annual turnover of £1.2 billion, GSTFT has a national and international reputation for managing and delivering a vast range of clinical research at scale, as well as for the corporate integration of research as a core business activity incorporating hosting functions and strong collaborative partnering to create a hub of research management expertise.

The Trust recognises the importance that commercial acumen and discipline brings to the long term sustainability of the organisation, especially in respect of working with complex and varied providers and identifying new revenue streams. GSTFT is a UK leader in strategic and joint ventures in healthcare delivery and as a result, the Trust now has the largest commercial directorate of any Trust within UK. The Trust’s Commercial Directorate, as the commercial arm of the organisation, works closely in support of Trust services to develop and deliver external contract income. This income generation is achieved by using the reputation, skills, capacity and location of the Trust and its staff. The Commercial Directorate builds on over 20 years' experience of delivering health services to external organisations both nationally and internationally.

University of Liverpool

The University of Liverpool is a world famous brand; it is one of only two UK Higher Education institutions to have a campus in China, has opened an innovative new campus in London and is the largest provider of wholly online degrees in Europe. Our research expertise spans a broad range of disciplines and is world leading in a number of subject areas. We have a national profile for our contribution to widening participation in UK Higher Education, ensuring that no student able to benefit from studying at a Russell Group University is deterred from applying as a result of financial constraints.

The University has ambitious plans for growth and has been pursuing a transformation agenda for a number of years. This is manifest in part in significant development of our University campus and the introduction of award winning Central Teaching Laboratories and on-campus student accommodation, a £25m investment in our libraries, £36m investment in our engineering facilities alongside a recent overhaul of Guild of Students building which has been transformed as a result of £12m investment.

Newcastle University

Newcastle upon Tyne is one of the oldest university cities in England. The University has one of the largest EU research portfolios in the UK and attracts over 20,000 students from more than 120 different countries. Teaching and research are delivered in 24 academic schools and 40 research institutes and research centres, spread across three Faculties. The university offers around 175 full-time undergraduate degree programmes in a wide range of subject areas spanning arts, sciences, engineering and medicine, together with approximately 340 postgraduate taught and research programmes across a range of disciplines.

Newcastle University has a world-class reputation for research excellence and spearheads three major societal research challenges that have a significant impact on global society: Ageing and Health, Sustainability, and Social Renewal.Newcastle has received awards for pioneering research into treating polluted water from abandoned mines, world-leading work on ageing and health and internationally renowned research into sustainable rural economies and societies.

King’s College London

King's College London offers an intellectually stimulating environment in which to work, in which staff are dedicated to the advancement of knowledge and learning, in the service of society. As a multi-faculty institution, Kings provide high-quality teaching, research and innovation across the sciences, humanities, medicine, law, dentistry, and social sciences and are a member of the Russell Group, of research intensive higher education institutions. King’s is committed to maintaining the highest standards in research and education and is the largest centre for the education of healthcare professionals in Europe, and is home to five Medical Research Council Centres spread across its three teaching hospitals.

King's is one of the top 20 universities in the world (2014/15 QS World University Rankings) and is the fourth oldest university in England and based in the heart of London, King's has more than 26,000 students from nearly 140 countries, and more than 7,000 employees.

Imperial College London

Imperial College London is a science-based university with an international reputation for excellence in teaching and research. Consistently rated amongst the world's best universities, Imperial is committed to developing the next generation of researchers, scientists and academics through collaboration across disciplines.