Senior Trial Manager

Job id: 071585. Salary: £41,386-£48,414 per annum, including London Weighting Allowance.

Posted: 18 July 2023. Closing date: 04 August 2023.

Business unit: Research Management & Innovation. Department: KCTU Clinical Trials Unit.

Contact details:Caroline Murphy. [email protected]

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

Job description

We are seeking an enthusiastic individual with a keen interest in the management of clinical trials and ideally with previous experience of working in a research environment.  The successful candidate will work within the accredited UKCRC King’s Clinical Trials Unit (KCTU), providing administrative support to large multi-centre clinical trials. The post holder will work closely with the trial’s Chief Investigator and the KCTU’s Operational Director, to ensure rigorous trial standards are maintained. The trial manager appointed will have the opportunity to be assigned to one of a number of trials currently in setup, including international and platform CTIMP trials, surgical trials of AI technologies, psychological therapy trials, paediatric trials, trials in transplantation and many more.
 

Duties will include:

• 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
• Manage the Trial Master File and version control all trial documents 

This post will be offered on an indefinite contract. 

This is a full-time  post.

Key responsibilities

• Responsible for the day-to-day management of the trial  
• Act as the main point of communication for the trial, the research team, recruiting sites and all other relevant bodies.  
• Develop, implement, and update the Trial Master File and version control relevant study documents 
• Develop an in-depth knowledge of the trial protocol, to be able to respond to all queries or appropriately escalate 
• Monitor and coordinate intervention supplies and intervention compliance 
• Plan and monitor recruitment of participants into the trial, identifying barriers and implementing strategies to improve recruitment.  
• Initiate sites, ensuring all have the required documentation, appropriate approvals, and an understanding of the protocol.  
• In conjunction with the trial statistician and data manager, monitor data quality and assist with data cleaning, to achieve an accurate and complete dataset.  
• Schedule and administer Trial Management Group meetings, Trial Steering Committee meetings and Data Monitoring Committee meetings and take minutes as appropriate 
• Prepare and submit amendments for ethics and regulatory approval, annual progress reports, contribute to reports to funders and manage communications with the Sponsor organisation. Ensure appropriate contractual arrangements are in place and documents held on file. 
• Plan and monitor financial aspects of the trial, including forecasting major expenses and identifying underspend or overspend 
• Produce promotional material and dissemination plans 
• Develop written procedures for trial processes where appropriate 
• Any other duties appropriate to the grade as directed by the supervisors.  
• Delegate any tasks as appropriate  
• Supervise and manage junior staff 

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.  

Skills, knowledge, and experience 

Essential criteria  

Degree in a science subject (or equivalent) and a post graduate qualification with a research methodology element  

Proven commitment to ongoing skills development 

Excellent IT skills including working with databases 

Understanding of medical terminology, either through study or working in a medical environment  

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

Excellent organisational skills with an ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them  

Ability to work on own initiative and prioritise own schedule without supervision 

Experience of working in research or clinical trials, with an understanding of GCP guidelines  

Experience of using complex databases and management information systems 

Excellent verbal and written communication skills, particularly in the context of scientific writing, reports, presentations, and telephone manner. 

Willing to travel with the UK flexibly to accommodate the needs of the project  

Ability to show attention to detail and high standards of accuracy in all aspects of work, with a flexible, enthusiastic, team-working attitude  

Desirable criteria

Formal qualification in clinical trials (or working towards one) 

Experience of financial planning and implementation 

Experience of supervising other staff 

Experience in the field of study of the trial 

Previous experience of writing written procedures