Senior Trial Manager
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 - 100% full time equivalent but we also encourage part time applicants to apply as there may be more than one post available.
- 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
- 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
- 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