UNIVERSITY OF NOTTINGHAM
RECRUITMENT ROLE PROFILE FORM
Job Title:
Senior Trial Manager
School/Department:
School of Community Health Sciences - Nottingham Clinical Trials
Unit (CTU)
Salary:
£35,938 – £44,166 pro rata depending on skills & experience.
Salary progression beyond this scale is subject to performance
Job Family and Level:
Research & Teaching level 5
Contract Status:
This post is offered on permanent contract
Hours of Work:
Full-time preferably; however applications are also welcome from
candidates wishing to work part-time. Please specify in your
application if you wish to work part time and the number of
preferred hours.
Location:
Nottingham Clinical Trials Unit (CTU), C Floor, South Block,
Queens Medical Centre, Nottingham, NG7 2UH
Reporting to:
Professor Lelia Duley, NCTU Director
The Purpose of the New Role:
This is a key new role based at the Nottingham Clinical Trials Unit - a busy and expanding
academic trials unit. The role holder will be expected to support the Director of the Nottingham
Clinical Trials Unit (NCTU) and the NCTU Senior Management Team in developing and
delivering the Unit’s portfolio of high quality clinical trials of national and international
relevance, by working closely with the Data Manager and Quality Assurance Manager to
provide effective oversight of NCTU operational management, ensuring effective, high quality
and timely project delivery. This will include contributing to publication of the trial protocol,
and of the trial results. Also, the post holder will be expected to work within the
multidisciplinary NCTU project development team that supports chief investigators in
developing their trial protocol and preparing high quality grant applications. Over time, the
successful candidate will be expected to develop a portfolio of trial methodology-related
research.
Working Environment:
The department is an active research environment with approximately 30 research and
administrative staff working on a variety of related projects. There is a good collaborative and
highly interdisciplinary atmosphere in the department, and many of the main projects are able
to gain from each other in a synergistic way. For further information see:
http://ctu.nottingham.ac.uk/ctu/
There are a number of trials being co-ordinated through the Nottingham Clinical Trials Unit,
which is a UKCRC registered clinical trials unit. The studies are multi-centre studies involving
up to 40 recruiting centres throughout the UK.
Main Responsibilities
1.
Research:
 Contributing to developing the NCTU portfolio of high quality research, by
working within the NCTU multidisciplinary team supporting chief
investigators to develop their protocol and prepare high quality grant
% time
per year
55
applications, for example to the NIHR boards, MRC and charities.
Supporting the NCTU Director and Senior Management Team to deliver
research excellence by working with the Data Manager and Quality
Assurance Manager to provide effective oversight of NCTU operational
management, including developing standardised processes for high quality
trial conduct, and ‘fit for purpose’ implementation of these process.
 Maintaining research excellence by providing high quality project
management and trial management expertise to a specific programme of
trials within the NCTU portfolio. This will include line management of the
trial managers, and ensuring high quality compliance with appropriate
regulatory and governance requirements.
 For this specific programme of trials: taking a leadership role in ensuring
prompt publication of the protocol; and contributing to the writing of the
results papers, with timely submission to a peer reviewed journal.
 Developing specific expertise in clinical topic areas and/or types of trial
design relevant to the NCTU portfolio of work.
 Providing project management and trial management expertise to trials
which are supported by NCTU, but are primarily co-ordinated from outside
the unit.
 Contributing to developing an NCTU programme of methodological research
in trial design and conduct.
 Helping ensure NCTU remains up to date with developments in the
methodology of clinical trials, by attending relevant conferences and
training, and by proving training within NCTU.
 Working with the Quality Assurance Manager and Data Manager to ensure
NCTU is up to date with research regulations and governance.
 Over time, the successful candidate will be expected to develop their own
portfolio of trials-related methodological research.
Management:
 Workload planning, monitoring capacity and allocation of projects against
measurable metrics.
 Ensuring that NCTU trials are delivered on target and within budget.
 Ensuring that the NCTU programme of work complies with the appropriate
requirements of research governance and regulation.
 Providing induction training, line management, and personal development
and performance reviews for Trial Managers and Trial Administrators.
 Managing recruitment of new trial project staff including drafting job
descriptions, short-listing, and interviewing. Managing the offer and
acceptance process, liaising with HR as appropriate.
 Working with the Data Manager to developing effective systems for
monitoring NCTU trial-specific activity and data quality.
 Liaise with appropriate groups/staff both within the University and local
organisations on project management issues.
 Develop and lead a Junior Trial Manager Mentoring programme.
Any other duties appropriate to the grade and role of the post holder.

2.
3.
Knowledge, Skills, Qualifications & Experience
Essential
Qualifications/
 Degree (or equivalent) in health
Education
related sciences
or
 Extensive experience in clinical
trials research
Skills/Training
 Excellent project management
skills, with evidence of effective
project management within multicentre trials and other complex
trial designs
 Excellent knowledge and expertise
in trial design, trial conduct and
40
5
Desirable
 PhD or MSc (or equivalent),
preferably in clinical trial
related subject
 Financial awareness and
financial management skills
 Evidence of the ability to
publish in international
journals
 Experience of developing
successful grant applications
Experience
Other
trial delivery
 Ability to communicate and work
effectively with both academics
and clinicians
 Evidence of the ability to publish in
national and international journals
 Strong leadership skills
 Ability to work collaboratively
across disciplines
 Evidence of being self-motivated
within research, and able to take
appropriate responsibility
 Excellent ability to prioritise, and
to work flexibly and effectively
under pressure
 Able to enjoy and work effectively
in a demanding and challenging
environment
 Up to date knowledge of Clinical
Trial Regulations, and research
governance guidelines
 Experience in clinical trial
coordination/management and a
track record of successfully
completed trials
 Experience of contributing to
successful grant applications
 Experience of writing trial
protocols, trial materials,
regulatory documentation, and
research papers
 Proven record in delivering multicentre, and other complex
randomised trials
 Extensive knowledge of the set-up,
costing, management and delivery
of clinical trials
 Experience of managing staff
• Willingness to travel within the UK
sites
 Experience in presenting to
national and/or international
scientific meetings
 Track record of publication in
peer reviewed journals
 Experience of MHRA and
sponsor audits
Due to the requirements of the UK Border and Immigration Agency, applicants who are not UK
or EEA nationals and whose immigration status entitles them to work without restriction in the
UK will be considered on an equal basis with UK and EEA nationals. Other non-UK or non-EEA
nationals whose employment will require permission to work subject to a resident labour
market test may only be considered if there are no suitable UK or EEA national candidates for
the post. Please visit http://www.ukba.homeoffice.gov.uk/ for more information.
Informal enquiries may be addressed to Matthew Leighton, Nottingham Clinical Trials Unit
Nottingham Health Science Partners, C-Floor, South Block, Queens Medical Centre,
Nottingham, NG7 2UH, tel: 0115 8844929 or email: matthew.leighton@nottingham.ac.uk.
Please note that applications sent directly to this email address will not be accepted.
Please quote ref. MED/08276.