Job Description and Person Specification (HR5) /
Job Description
School/Department: / Faculty of Medicine, Clinical Trials Unit
Post Title: / Senior Clinical Trials Manager
Please enter Level under appropriate Career Pathway / ERE / TAE / MSA / CAO / R.Nurse / Clinical
5
ERE Category / Academic Posts / Non-Academic Posts
Academic
(mixed) / Research
only / Teaching
only / Enterprise / Education Development
Post Responsible to (and Level):
Posts Responsible for (and Level): / Associate Director, CTU (level 6 MSA)
Clinical Trials Managers (level 5 MSA)
Job Purpose:
  • To lead the non–IMP and complex intervention trials portfolio within The University of Southampton Clinical Trials Unit (CTU), providing input and oversight of trial development and management activities.
  • To develop and line manage a team of Clinical Trial Managers to ensure trials are coordinated, developed and maintained effectively within the CTU and conducted to required standards, and to advise external staff working on trials within the portfolio.
  • To provide research support to staff and working parties to assist with development and operational management of clinical trials and other well designed studiesbefore grant approval and/or activation.
  • To act as deputy to the Associate Director of Operations for trial management issues as required.

Key Accountabilities/Primary Responsibilities:
  • To be a senior member of the CTU management team. Developing its expansion into non-IMP and complex intervention studies, actively creating interest within the local clinical community in developing studies, targeting NIHR funding opportunities as a priority.To provide professional leadership and act as an accessible resource on clinical trial and study designs management. To identify and lead in initiatives and developments relevant to the management and conduct of studies within CTU.
  • To actively, develop and line-manage, support and advise Clinical Trial and Study Managerswithin their group responsible for the coordination of a portfolio of clinical trials and studiesensuring adequate and effective staff cover at all times. To be responsible for relevant Human Resource (HR) requirements including recruitment, induction, appraisal, staff development, discipline and grievance procedures.
  • To maintain oversight of the overall conduct and performance of studies within their portfolio. This will include identifying significant problems with the conduct of studiesmanaged by the Unit and taking remedial action as necessary. To introduce and monitor performance metrics for trials conducted by CTU.
  • To lead in setting up and maintain good working practices and policies relating to study management within the CTU. To determine when changes are required and oversee their implementation, this will include assisting with the preparation and updating of Standard Operating Procedures (SOPs). Ensure SOPs reflect best practice and international legislation and are adhered to by all trial management staff. Where appropriate identify problems, causes and solutions at Investigator sites and take appropriate steps to resolution.
  • To work with and support University Hospital Southampton NHS researchers to develop new studies.
  • To assist the Director with the identification and assessment of new studies suitable for CTU involvement. This will include liaising with Central RDS, NIHR, NETSCC, BRU, BRC, in Southampton.
  • To collaborate with other research support groups within the University and UHS to develop better communication and provide a more streamlined and co-ordinated service for researchers.
  • Cost new studies, help to develop grant applications and manage clinical trial/studies grants.
  • To ensure study activities are adequately resourced, and to assist in developing and maintaining a resourcing model for this area of the CTU.
  • Regularly communicate with study funders to ensure progress reports and communication is appropriate.
  • To assess unmet need within Southampton in clinical trial support, and promote partnership working withCTU.
/ % Time
20
10
15
10
5
5
10
5
10
5
5
Internal & External Relationships: (nature & purpose of relationships)
  • Accountants within the University and UHSfinance department
  • R&D departments within the University of Southampton and University Hospitals Southampton NHS Trust for Sponsorship issues
  • Southampton Clinical Research Institute (SCRI), for study collaboration and co-ordination within the University and Trust. This includes:
  • South Central Research Design Service
  • National Cancer Research Institute (NCRI) Clinical Studies Groups, to maintain links with cancer research community and other non-cancer equivalents.
  • NIHR.To include trials on NIHR list of approved trials, discuss concerns, update database.
  • NIHR CRN and UKCRC, to access support for research infrastructure and to maintain registered status of CTU.
  • NIHR Clinical Research Network (CRN). Regular correspondence with Research Delivery Managers
  • Regulatory agencies – MHRA (if appropriate), NRES, R&D departments, PCTs
  • Trial funders, including NIHR Health Technology Assessment Programme and Cancer Research UK
  • TSC / TMG / DMEC for specific trials
  • Collaboration with other clinical trials units.

Special Requirements:
The Senior Clinical Trial Manager will be based at Southampton General Hospital. There will however be a requirement to travel to meetings and conferences throughout the UK and occasionally internationally.
Flexible working may be required in order to maintain a smooth running service.
The post is suitable for an applicant who wishes to work part-time
Person Specification
Criteria / Essential / Desirable / How to be assessed
Qualifications, Knowledge and Experience: / Postgraduate degree/equivalent professional qualification
Expert knowledge of clinical trials, other well designed studies (including complex interventions), trial methodology and regulatory requirements.
Knowledge & expertise of the challenges for managing trials of different types (IMP, non-IMP)
Formal training in ICH-GCP
Computer literate
Substantial experience in the design, conduct, analysis and reporting of clinical trials and other well designed studies
Experience of budgetary control and reporting
Experience in developing SOPs
Experience of collaborating in and managing multidisciplinary project teams
Experience of advising and influencing at senior levels
Experience of working with NHS clinicians who are research naïve / Familiar with UK NIHR portfolio
Working knowledge of meta-analysis and systematic review techniques
Experience in understanding of use of statistical and data management software / Application or interview
Planning and Organising: / Established organisational skills and ability to oversee a number of projects
Methodical, practical, with excellent attention to detail
Able to maintain judgement under pressure and meet deadlines
Proven track record in the delivery of research projects to deadline and to a high quality / Ability to plan and manage complex projects
Have project managed NIHR studies before / Application or interview
Problem Solving and Initiative: / Innovative, able to problem solve and be decisive
Proven ability to successfully negotiate clinical trials regulations / Interview
Management and Teamwork: / Excellent demonstrable management and leadership skills
Ability to identify priorities
Ability to delegate
To be able to work both independently and collaboratively with medical, scientific and technical staff / Have co-ordinated international research.
Have the ability to motivate others. / Application or interview
Communicating and Influencing: / Writing skills for drafting protocols, reports, funding applications and regulatory documents
Able to communicate complex clinical trial and other study information clearly to a range of staff groups, patients and public. Including presenting research findings / Interview
Other Skills and Behaviours: / Ability to negotiate with academic and private sector stakeholders
Ability to think strategically, for example in developing the portfolio of trials to be run by the group / Interview
Special Requirements: / Willingness to travel / Interview

Job Hazard Analysis Form - Appendix to Job and Person Specification

Please tick one of the following statements:

This post is an office-based job with routine office hazards e.g. use of VDU (if ticked, no further information needs to be supplied) / 
This post has some hazards other than routine office e.g. more than use of VDU

Please tick all those that apply, and put N/A if not applicable

Environmental Exposures / O* / F / C
Outside work
Extremes of temperature (eg fridge/ furnace)
Potential for exposure to body fluids ##
Possible Contact with patients in a clinical/home setting ##
Noise (greater than 80 dba- 8 hrs twa) ##
Exposure to hazardous substances (eg solvents, liquids, dust, fumes, biohazards, animals). Specify ………………………………………….. ##
Frequent hand washing
Ionising radiation.
Equipment/Tools/Machines used
Food Handling ##
Driving university vehicles(e.g. car/van/LGV/PCV) ##
Use of latex gloves (note: prohibited unless a specific clinical necessity)
##
Vibrating tools ( eg strimmers, hammer drill, lawnmowers) ##
Physical Abilities
Load manual handling.
Repetitive Crouching/Kneeling/Stooping
Repetitive Pulling/Pushing
Repetitive Lifting
Standing for prolonged periods
Repetitive Climbing i.e. steps, stools, ladders
Fine motor grips (eg pipetting)
Gross motor grips
Repetitive reaching below shoulder height
Repetitive reaching at shoulder height
Repetitive reaching above shoulder height
Psychosocial Issues
Face to face contact with public
Lone working
Shift work/night work/on call duties ##

O – Occasionally (up to 1/3 of time); F – Frequently (up to 2/3 of time); C – Constantly (more than 2/3 of time) ## denotes to HR the need for a full PEHQ to be sent to all applicants for this position.

1