Job Description and Person Specification (HR5) /
Job Description
School/Department: / Faculty of Medicine, Clinical Trials Unit
Post Title: / Clinical Trials Data Manager
Please enter Level under appropriate Career Pathway / ERE / TAE / MSA / CAO / R.Nurse / Clinical
4
ERE Category / Academic Posts / Non-Academic Posts
Academic
(mixed) / Research
only / Teaching
only / Enterprise / Education Development
Posts Responsible to (and Level): / Senior Data Manager (level 5)
Posts Responsible for (and Level): / Data Officers (level 2b) and Data Entry Clerks (level 1b)
Job Purpose:
The University of Southampton Clinical Trial Unit (UoSCTU) is a UKCRC registered CTU which designs, initiates, conducts and analyses high quality national and international clinical trials to directly influence routine clinical practice.
The appointed person will take responsibility for the oversight of database development and clinical trial data management processes across a portfolio ofclinical trials within UoSCTU.
Key Accountabilities/Primary Responsibilities:
  • Contributetothe development, review and implementation of processes, policies, SOPs and associated documents affecting Clinical Data Management in UoSCTU
  • To be responsible for Clinical Data Management Activities within UoSCTU, regularly reporting to Senior Management Team and ensuring communication of key messages to all UoSCTU staff
  • Programme and validate new databases, including preparation of Validation Plans, Database Design Specifications, and Data Test Plans
  • Prepare study documentation, i.e. the data management plan (DMP), and Case Report Form (CRF) for each trial
  • Train new staff in use of Inform and provide technical support for Inform software
  • Organise and maintain training databases and training material
  • Data Entry and Medical Coding as required
  • Perform discrepancy management and generation/resolution of manual queries as required
  • Perform data reviews/ produce reports as required
  • Perform off-line data validation activities
  • Support team members with preparation for on-site monitoring visits
  • Contribute to SAE reconciliation activities with the Quality and Regulatory team
  • Participate in the development and maintenance of quality systems and clinical audit of research activity, and adhere to all CTU and University policies and procedures
  • Any other duties appropriate to the band assigned by the Senior Data Manager or Senior Management Team.
/ % Time
5
10
10
10
10
10
5
5
5
5
5
10
5
5
Internal & External Relationships: (nature & purpose of relationships)
  • Other staff within University of Southampton Clinical Trials Unit, to ensure good working relationships
  • Departmental IT staff and external electronic database services to develop and manage databases.
  • Trial specific groups (Management groups, Trial Steering Committees, Data Monitoring Ethics Committees) to provide and discuss trial data.
  • Staff at participating sites, to secure trial documentation and resolve data queries
  • Research Networks across the UK; providing regular updates and trial information as appropriate.
  • Trial funders, to provide trial data.

Special Requirements: The Clinical Trials Data Manager will be based at Southampton General Hospital within the established UKCRC registered CTU. Travel to participating centres within the UK and possibly internationally may be required in some instances.
Person Specification
Criteria / Essential / Desirable / How to be assessed
Qualifications, Knowledge and Experience: / Relevant HND, Degree, NVQ4 or first level professional qualification (or equivalent qualification or experience)
Knowledge and experience of statutory clinical trial regulations, GCP and research governance requirements.
Knowledge of database design and implementation
Experience of data management for clinical trials in the non-commercial or commercial health research sector
Experience of medical data, data entry and validation techniques.
General IT Literacy – MS Office applications / A levels or equivalent
Evidence of continuing professional development
Knowledge of quality management systems.
Knowledge or experience of electronic data capture (EDC) data management systems / Application or interview
Planning and Organising: / A high degree of organisation
Good attention to detail including high standards of accuracy / Application or interview
Problem Solving and Initiative: / Ability to prioritise tasks / Application or interview
Management and Teamwork: / Good interpersonal skills
Ability to liaise with individuals at all levels at different establishments / Experience of line management / Application or interview
Communicating and Influencing: / Communicates effectively in both spoken and written English
Excellent telephone manner / Application or interview
Other Skills and Behaviours: / Personal drive and initiative
Ability to work independently in a team environment
Self-motivated / Application or 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 ##
Noise (greater than 80 dba - 8 hrs twa) ##
Exposure to hazardous substances (eg solvents, liquids, dust, fumes, biohazards). 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 specific clinical necessity) ##
Vibrating tools ( e.g. 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 (e.g. 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.

FOR SCHOOL/SERVICE USE ONLY / ResourceLink Post Number
Which post does this job report to
Is this post a Line Manager? / Yes / No
If yes, which posts directly report into it? / ResourceLink Post Number
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