What do Trial Management Teams do?
Trial Management Teams
Our trial management teams are key to delivering our trials on time and on target. They work in collaboration with investigators, funders and NHS site staff to ensure that trials have a valuable outcome for patients and the cancer research community.
There can be interesting challenges to overcome during the life of a clinical trial and being part of a trial management team requires a varied skillset - the ability to organise and complete multiple tasks, to be proactive, to be a good communicator with clinical and site staff, as well as members of committees and your immediate colleagues.
Trial Managers are experienced in clinical trial management, they have detailed knowledge of clinical trial processes, ICH GCP, and the UK’s ethical and regulatory systems for clinical trials (CTIMPs and nonCTIMPs). The trial manager will often be responsible for line management of a trial management team.
Trial managers work closely with the Chief Investigator to develop a protocol, securing necessary approvals, establishing appropriate systems and procedures in all areas of trial activity to ensure trial runs on time, on target.
- overall project management for on time, on target delivery of the trial
- selection and management of study sites (hospitals)
- collection of robust accurate trial data
- liaising with third parties (e.g. labs, drug suppliers, funders)
- maintaining the Trial Master File, a central record of all trial information, communication and data which (for most trials) is subject to regular inspection by the MHRA
Expecting the unexpected and multi-tasking skills are essential. Many of our trial managers have been promoted from prior roles as CTAs in OCTO or other units.
Clinical Trial Administrator
Clinical Trial Administrators usually have experience in other areas of clinical research before working in clinical trials, for example in in laboratories, data management roles or in a healthcare setting. They will have an understanding of the UK’s ethical and regulatory systems for clinical trials (CTIMPs and nonCTIMPs)
CTAs support Trial Managers in day-to-day running of trials, particularly in relation to:
- trial supplies
- data collection and cleaning
- oversight and day to day contact with study sites.
They are involved in routine data and monitoring checks to ensure that the trial is being run efficiently and in compliance with applicable standards.
Multi tasking skills are again essential in this role.
Clinical Trial Support Officer
Clinical Trial Support Officers in OCTO support many administrative trial tasks, and often over a number of trials.
The CTSOs most important roles is to check new data submitted to OCTO from participating sites (hospitals). This ensures that ongoing collection is of high quality, complete, accurate and consistent data. If there are queries CTSOs will work with sites to obtain clarification or correction so that data are available for defined analyses.
Attention to detail is a key part of the CTSO role, CTSO is a great place to start and get to know trial management if you are new to clinical trials.