Faculty of Medicine and Health
School of Dentistry
Dental Translational and Clinical Research Unit (DenTCRU)
DenTCRU Operations Manager for Translational Research and Clinical Trials
We are looking for an enthusiastic manager to oversee translational research and clinical trial
activities within the Leeds Dental Translational and Clinical Research Unit (DenTCRU). You will be
involved in a wide range of activities centred upon operational management of the DenTCRU
research portfolio in addition to leading clinical governance activity within the Unit and working with
new partnerships with external funders. You will also support the development of the School’s
research portfolio through close working with other DenTCRU staff, support ethical applications for
work to be carried out within the Unit and develop and expand as appropriate Standard Operating
Procedures (SOPs) to ensure highest standards of clinical governance.
Educated to degree level in a scientific subject (or equivalent qualification/equivalent experience)
you will have excellent communication and project co-ordination / management skills and a
working knowledge of the regulatory and governance environment relating to clinical research.
You will be able to work well within a multidisciplinary team including health professionals, basic
scientists, statisticians, and with key external stakeholders to facilitate the development of the
DenTCRU portfolio of research.
You will be able to motivate others and work independently and flexibly under pressure whilst
advancing the DenTCRU research agenda, with a proven ability to work enthusiastically with
internal and external stakeholders.
The University of Leeds is committed to providing equal opportunities for all. The
university is a charter member of Athena SWAN and holds the Bronze award. We will be
happy to consider job share applications and are committed to flexible working for all our
employees.
University Grade 7 (£31,342 to £37,394 p.a.) depending on qualifications and experience.
Informal enquiries regarding the post should be directed to Professor Sue Pavitt, Director
of DenTCRU and Division Head for Division of Applied Health & Clinical Translation, tel. +44
(0)113 343 6985, email: s.pavitt@leeds.ac.uk or Professor Jennifer Kirkham, Division Head
for Oral Biology, tel. +44 (0)113 343 6156, email: j.kirkham@leeds.ac.uk.
If you have any specific enquiries about your online application please contact Christina
Dowe, tel. +44 (0) 113-343-8334, email: c.h.dowe@leeds.ac.uk
Job ref: MHDEN1022
Closing Date: 26 May 2015
Purpose of the post
Research within the School of Dentistry (formerly Leeds Dental Institute) was rated highly in
REF2014 (returned in Unit of Assessment 3: Allied Health Professions, Dentistry, Nursing &
Pharmacy), with 91% of its research rated as world leading or internationally excellent. The
successful candidate will join a group of high quality, highly active researchers working within a
lively, multi-disciplinary research environment with a long held reputation for excellence in
interdisciplinary research. The School’s goal is to carry out excellent clinical research underpinned
by outstanding basic dental science, in order to meet the international priority needs for
translational and clinical research in dentistry. To deliver to our strategic goals, a flagship
dedicated Dental Translational Clinical Research Unit (DenTCRU) has been established within the
School funded through a prestigious capital award from the Wellcome Trust. The facility,
DenTRCU, will facilitate translation of research findings for patient benefit and underpin health
services research in dentistry.
Main duties and responsibilities
This is a key role for the delivery of our translational clinical research and clinical trials agenda
“from bench to chair side and back again”. You will work to support the DenTCRU Director and
will take responsibility for leading on specific areas of work for the DenTCRU research portfolio (or
School of Dentistry as required). Specifically, supporting Principal Investigators ensuring key
project work is initiated and completed successfully in line with planned timelines and to the
highest standards of clinical governance. In addition, you will be responsible for establishing and
maintaining channels of regular communication with both the internal and external academic
clinical research communities. The successful post-holder will be expected to work closely with the
Director of DenTCRU to deliver:
Growth of DentCRU
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Contribute to long term strategies and processes to ensure DenTCRU’s growth, capacity
building and long term sustainability.
Work collaboratively with the School’s Business Manager (Mrs Claire Godfrey) and Research &
Innovation Manager (Mrs Ruth Kayman) to support and pro-actively build strategic
relationships with key partners, including (but not limited to) NHS Trusts and the Leeds Dental
Hospital, commissioners and the NIHR clinical research networks or their equivalents.
Lead on the day to day management of the General Dentist Research Network and Patient
Public Involvement Forums once established.
DenTCRU Translational Research & Clinical Trials Management
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Be the initial point of contact for all enquiries to DenTCRU, providing detailed guidance and
advice.
Provide leadership for administrative management of the DenTCRU research portfolio,
specifically, expand and further develop current systems and processes (including Standard
Operating procedures (SOPs), monitoring and quality assurance) to ensure adherence with the
highest international standards of clinical research governance.
Ensure that appropriate security measures are in place to prevent unauthorised access to
patient named data in accordance with the Data Protection Act.
Provide leadership for clinical research governance oversight & guidance for protocols and
applications for ethical approval from staff and postgraduate students to ensure highest
standards of Good Clinical Practice (GCP). Use initiative and experience to identify key
problems and direct liaison with sponsor to achieve resolution.
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Provide leadership for operational management for the DenTCRU research portfolio.
Supporting academic staff and postgraduate students in the management and delivery of high
quality clinical and translational research projects.
For DenTCRU clinical trials, working in conjunction with the principal investigator and sponsor,
oversee the delivery of the trial to ensure compliance to the Clinical Trials Regulations,
including ICH GCP, Ethics, and MHRA (supporting applications and approvals), research
governance and Data Protection.
Individual project management & monitoring - plan the management of specific research
projects and monitor project activity (including data quality, compliance, recruitment) and
progress against planned timelines. Identifying any issues potentially affecting planned delivery
and with timely liaison with the Director of DenTCRU identify and implement solutions.
Lead on the timely reporting of safety issues to Director of DenTCRU and sponsor/regulators.
Independently deal with project-related queries or resolving queries through liaison with
DenTCRU Director and /or appropriate clinical or subject experts, to ensure responses are
dealt with promptly and accurately.
Use initiative and experience to identify key problems, propose innovative solutions and raise
them at project team meetings working collegiately and ensuring appropriate action is taken
and Director of DenTCRU is kept informed.
Devise solutions to complex and unique project specific problems, within a changing
environment through liaison with key stakeholders across partner organisations and that the
Director of DenTCRU is kept informed.
Establish and co-ordinate as needed: [a] Project Management working groups and meeting
with external stakeholders such as the Principal Investigator, Co-investigators/ collaborators,
the site Principal Investigators. [b] Trial Steering committees (TSC)/ or Steering Advisory
Group(SAG). [c] Data Monitoring and Ethics Committees (DMEC). [d] Ad hoc Meetings with
Funders, Industry, Clinical Trials Units, Collaborators, and Leeds Teaching Hospitals Trust
Research and Development Unit.
Maintain an overview and monitor the progress of the DenTCRU portfolio and staffing
allocations for current and planned DenTCRU portfolio timelines, and ensure timely reporting to
the Director of DenTCRU and the School Research & Innovation Manager.
Coordinate communication of project progress, preparation of reports, briefing papers and
articles to inform relevant groups and audiences of project progress and outcomes as required
(e.g. periodic progress reports to NRES and funders).
Contribute to the DenTCRU Senior Management Group relating to project management,
planning and review.
Provide operational leadership to ensure the DenTCRU facility is maintained in good working
order, through liaison with the School of Dentistry Business Manager). Ensuring that the facility
is fully functional, serviced and calibrated and fit for site inspection by regulators or industrial
sponsors.
Ensure seamless delivery of DenTCRU operational and business components (for example,
that trial management is discussed to consider both scientific integrity and budgetary
implications for co-planning delivery, working collaboratively with the School Business
Manager, Research & Innovation Manager and Faculty Research office.
School of Dentistry Roles:
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Act as the second-Deputy to the School of Dentistry’s person designate for the Human Tissue
Act (HTA). You will have responsibility for management oversight to ensure appropriate
consent, collection and transfer of samples according to HTA to our Oral Biology laboratories
at the St. James Hospital site where the other deputy will have responsibility for covering
biobanking activities.
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Become an advisor on the Dental Research Ethics Committee and review applications to
ensure adherence to GCP. With a view to leading on review of those application involving
clinical studies of healthy volunteers and also those involving the HTA.
Communication
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Establish good communication links between DenTCRU and key internal and external
stakeholders
Update the content of the DenTCRU Trials accrual information and ensure that changes
advised are dealt with promptly and working proactively with Registered Clinical Trials Units to
ensure information is checked and updated regularly
Compile and distribute communications as required to the academic clinical research
community on relevant Oral Health projects and initiatives
General
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Maintaining a good up to date awareness of clinical trial-related issues, particularly issues
impacting on clinical research and management of oral health or devices trials to ensure
DentCRU is compliant with GCP and with any new Governance arrangement/legislation
relating to clinical trial conduct.
Develop and maintain an awareness and understanding of the key activities of the School of
Dentistry and DenTCRU
Undertake any ad hoc initiatives as required by the DenTCRU Director
Take initiatives in personal and professional development and attend such courses and events
as may be appropriate.
Actively promote and engage with the University’s People Management Framework
(http://www.leeds.ac.uk/hr/development/pmf.htm) to ensure high standards of employment
practices and staff management across DenTCRU.
Adhere to University values and standards, including the Leadership and Management
Standard, and in line with University policies and procedures and local Faculty/School
benchmarks as appropriate, upholding high professional standards and leading by example.
Coach and mentor less experienced members of the DenTCRU team to optimise performance
and learning.
Maintain a safe and healthy work environment, including ensuring compliance with health and
safety legislation and the undertaking of appropriate risk assessments.
Comply with the University’s financial and procurement procedures and regulations,
undertaking relevant induction/training.
Carry out any other duties as reasonably requested within the scope and grading of the role.
This job description provides a framework for the role which will develop naturally over time and it
may be necessary to undertake other duties commensurate with the post as might reasonably be
required.
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 strategy and values is available at http://www.leeds.ac.uk/comms/strategy/
Key relationships
You will be directly responsible to Prof Sue Pavitt, Director of DenTCRU through whom you will be
accountable to the Dean of Dentistry and ultimately the Dean of the Faculty.
You will work closely with other staff based within DenTCRU in particular the DenTCRU Research
nurses who you will co-line manager, the School Research & Innovation Manager and other staff
within the School of Dentistry, in particular, the Director of Research & Innovation, and Heads of
Division. In addition, you will develop good external working links with staff in Clinical Trials Team,
clinical trials units, clinical colleagues in Leeds Dental Institute, the wider Dental research
community, funders, industry and relevant professional bodies and organisations.
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Person Specification
DenTCRU is a complex, diverse and ambitious development. A willingness to occasionally work
off the main campus site in outreach settings will be important to ensure deliver and monitoring of
the DenTCRU portfolio of research.
Specifically you need to be able to demonstrate the following experience and competencies:
Essential
 Educated to degree level in a scientific subject (or equivalent qualification/experience)
 Proven experience in a coordinating or managing role involving clinical research projects
 Effective communication and organisational skills demonstrated by a proven ability to support a
range of different projects simultaneously along with delivering good results
 Experience of working in a multidisciplinary environment and contributing to decision making
processes
 Operational experience of implementing processes to support research delivery and
governance compliance (e.g. working according to SOPs and monitoring processes)
 Knowledge of the regulatory and governance environment in the UK
 Ability to clearly and confidently communicate complex and sensitive information both written
and verbally in individual and group situations
 Demonstrate initiative and enthusiasm to support and motivate others whilst working
successfully as an independent member of a team managing priorities and deadlines
 Experience of effectively interacting with a wide range of professionals, including senior staff,
across a range of organisations
 Excellent IT skills including working experience of the Microsoft Office suite, specifically Word,
Excel, PowerPoint, and Outlook
Desirable
 Postgraduate Research qualification
 Experience of clinical trials co-ordination/management (e.g. protocol development, case report
forms, database design, study set-up, participant follow-up, data management, closure and
publication).
 Experience of working on industry sponsored clinical research
 Experience of setting up processes to monitor research progress and compliance to GCP (e.g.
development of SOPs and monitoring processes)
 Previous experience of working within a clinical context, working with clinicians or translating
the findings of research to a clinical setting
 Experience of ethics submission process, obtaining appropriate regulatory and governance
approvals
 Knowledge of the Human Tissue Act and MHRA Regulations
 Experience of establishing and maintaining databases
 Experience of managing resources, financial and/or other
Further information
Faculty Information
With more than 6,000 students, 1,600 staff and annual research income of £50m, 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 Dentistry
The School of Dentistry is newly convened in August 2013 following a separation of the NHS Trust
and University elements of the former Leeds Dental Institute. The School is committed to the
highest standards of academic excellence and works closely with partners in the Leeds Teaching
Hospitals NHS Trust to deliver high quality patient care and exceptional clinical training and
education at all levels from undergraduate teaching through to specialist registration. We aim to
underpin high quality clinical research with world class basic and applied science, in order to meet
international priority needs for research in dentistry and to deliver excellent research with impact
for patient and population benefit.
The School appointed a new Dean in 2013, Professor Helen Whelton (President of the
International Association of Dental Research 2013-2014). Professor Whelton’s plans include an
ambitious international clinical research programme, addressing unanswered questions about the
links between oral health and general health.
The School of Dentistry is situated on the second floor of the Worsley Medical and Dental building,
which also accommodates the Dental Hospital, the Medical School and the University of Leeds
Health Sciences Library. It is situated on the southern side of the University campus half a mile from
the city centre. The School recently expanded its estate and the basic sciences, in the Division of
Oral Biology, are situated in the Wellcome Trust Brenner Building on the St James’ campus,
providing high quality and purpose built laboratory provision and access to a wide range of cutting
edge facilities.
The School is organised into five administrative academic Divisions:
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The Division of Applied Health and Clinical Translation-Head of Division Professor S. Pavitt
The Division of Oral Biology - Head of Division Professor J. Kirkham
The Division of Oral Surgery, Medicine and Pathology - Head of Division Dr A. Mighell
The Division of Paediatric Dentistry and Orthodontics - Head of Division Professor M. Duggal
The Division of Restorative Dentistry – Head of Division Professor D.V. Clerehugh
Student Experience and Education Overview
The School of Dentistry is currently the most popular dental school in the United Kingdom. We
attract more applicants than any other school for our undergraduate programmes and we are the
second largest school for undergraduate dental education in the UK.
Student education at the University of Leeds’ School of Dentistry is internationally renowned for
being both flagship and innovative, and this is evidenced by the School offering the only
undergraduate masters’ programme in dental surgery in the UK.
In tandem with our
undergraduate masters’ dental surgery programme we also offer a Diploma in Dental Hygiene and
Dental Therapy and, in partnership with the Leeds Teaching Hospitals Trust, we are also involved
in the provision of Dental Nursing and Dental Technology training. This makes us unique, as we
are the only school that trains all members of the dental team. In tandem with our undergraduate
programmes we also offer an expanding portfolio of postgraduate dental programmes.
The quality of teaching on our undergraduate programmes is very high and all staff are committed
to continually developing our taught programmes. Recently the General Dental Council inspected
all our undergraduate programmes with all programmes being found to be of the highest standard.
Our programmes are completely modular and benefit from having Year and Module Leads with
Programme Leads managed under the direction of the Director of Student Education.
All members of staff within the School participate in both Undergraduate and Postgraduate taught
provision and this, we believe, maintains the high quality of our teaching, which is consistently
assessed by our students as being very high.
We have a student advice team, which supports all students within the school. This along with our
personal tutoring system, with which all staff engage, provides the highest levels of pastoral
support for our students.
Research Overview
In REF2014 the School of Dentistry (returned in Unit of Assessment 3: Allied Health
Professions, Dentistry, Nursing & Pharmacy) was rated very highly, with 91% of its
research rated as world leading or internationally excellent. The successful candidate will join
a group of high quality, highly active researchers. The School of Dentistry enjoys a lively, multidisciplinary research environment and has a long held reputation for excellence in interdisciplinary
research. We contribute to a number of the Faculty of Medicine and Health research themes.
Our vision is to use interdisciplinary expertise to understand the fundamental mechanisms of
disease, to identify and treat early, improve outcomes, restore function and address the needs for
prevention. We seek to extrapolate the findings and tools developed for dental research across to
biomedicine in general and position our research at the forefront of biomedical and health
sciences research. We have three Research Groups, each with internationally recognised
leadership:
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Basic Dental Sciences Research Group led by Professor J. Kirkham
Clinical Dental Research Group led by Professor D.V. Clerehugh
Dental Education Research & Scholarship Group led by Professor M. Manogue
The Groups collaborate extensively with each other and with colleagues within our Faculty
(Medicine and Health), as well as in other Faculties (e.g. Biology, Engineering, Mathematics and
Physical Sciences).
International Profile and Initiatives
In line with the University of Leeds strategy the School of Dentistry is committed to enhancing our
international profile through the development of key strategic partnerships. Formal collaborative
agreements between Leeds and Dental Schools in the Universities of Michigan, Osaka and
Nanjing have been established to promote excellence in international, multi-centre collaborative
research, particularly in clinical and translational research and regenerative technologies. Building
on shared expertise and knowledge amongst our partners we aim to work together to improve oral
health outcomes in our own communities and across the globe.
In addition to formal Memoranda of Understanding with the Universities of Michigan and Osaka we
have established a Joint Centre for Oral Health Sciences with the University of Nanjing. We are
also founder members of the World Universities Network for Oral Health Sciences, a network of
research intensive universities committed to addressing global challenges in Oral Health. The
impact from the development of our Strategic partnerships has included joint research through
staff/student exchange, resulting in publications, grant income and enhanced opportunities for
dissemination of research advances to a global audience.
Additional information
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 is located on Levels 5 & 6 of the Worsley Building. Disabled applicants wishing to review
access to the building 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.