Trial Manager

Job id: 083725. Salary: £43,205 - £50,585 per annum, including London Weighting Allowance.

Posted: 05 February 2024. Closing date: 19 February 2024.

Business unit: IoPPN. Department: Addictions.

Contact details:Gail Gilchrist. [email protected]

Location: Denmark Hill Campus. Category: Professional & Support Services.

ADVANCE-D is a UK multi-centre cluster randomised control trial of the ADVANCE-Digitally supported perpetrator intervention to reduce intimate partner violence (IPV), for men convicted of IPV who misuse substances.

Applications are invited for a Trial Manager based in the Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King’s College London to work with Professor Gail Gilchrist and others (from the Universities of Edinburgh, Manchester, Cardiff and York) to lead on set up, trial management and conduct of ADVANCE-D.

The costs and outcomes of ADVANCE-D over and above usual community justice offender management will be compared. Short, medium, and longer-term outcomes for men and their (ex)-partners will be assessed by research interview at 4 and 12-months and via linkage with health and criminal justice records at 24 months.

Applicants should have demonstrated experience of trial management and co-ordination of multi-centre (mixed-methods) randomised controlled trials from set-up to closure. Applicants must have a postgraduate qualification, with a research methodology element and a formal qualification in clinical trials (or working towards one).

This post will be offered on a fixed-term contract till 31 October 2027

This is a full-time post - 100% full time equivalent.

• Manage administration for the study, and actively contributing to the research planning and development in partnership with Principal Investigators, Executive and Steering Groups and Study Teams 
• be a key liaison with all university departments, relevant ethics and R&D committees, funding bodies etc 
• prepare and support meetings, boards, and committees, including the coordination and distribution of briefing documents and background materials, drafting presentations or taking minutes, as required 
• ensure all necessary approvals are in place, recruiting sites are initiated, staff are appropriately trained, and recruitment is maximised across all sites ensuring timely recruitment of study participants into studies 
• develop working guidelines for the trial as necessary and manage all communications with the Sponsor organisation 
• monitor the Trial Master File and version control all trial documents 
• monitor and manage trial budget 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.  

1.      A degree in a relevant or numerate discipline (e.g. psychology, health services research, criminology, sociology or related discipline) 

2.      Formal qualification in clinical trials (or working towards one) 

3.      Post graduate qualification with a research methodology element 

4.     Experience of working in research or clinical trials studies

5.     Proven experience of all stages of a clinical trial from start up to closeout

6.     Experience of using complex databases and management information systems

7.      Excellent IT skills including working with databases 

8.      Knowledge of project management methodology and commitment to acquire complete project management skills 

9.      The ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them 

10.    Ability to work on own initiative and prioritise own schedule without supervision and that of others 

11.    Excellent organisational skills 

12.    Excellent verbal and written communication skills, particularly in the context of scientific writing, reports and good telephone manner. Ability to persuade and deliver information effectively through presentations

Desirable criteria  

1.       Understanding of R&D funding and sponsor organisations, NHS or HMPPS research structure and organisation 

2.       Understanding of regulatory requirements pertaining to trials 

3.       Experience of financial planning and implementation 

4.       Experience of supervising other staff 

5.       Experience in the field of study of the trial 

Funding is available till 31 October 2027, subject to the successful completion of an internal pilot. 

This post is subject to Disclosure and Barring Service and Occupational Health clearance.