Download Faculty of Medicine and Health School of Medicine Leeds Institute of

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:
[email protected]. If you have any specific enquiries about your online application
please contact Sharon Collins or Nicola Johnson: e-mail: [email protected] or
[email protected]
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 [email protected] 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.