Clinical trial managers’ responsibilities are multifaceted and will vary from trial to trial. When developing a grant application, they include:
- Assisting with grant applications and costings
- Helping to identify appropriate clinical trial teams
- Developing timelines and plans.
Responsibilities once funding has been awarded include:
Developing timelines and plans to assist with the time-to-target agenda (including the ‘70-day clock’)
Coordinating the development and review of essential documentation
Preparing submissions to ethical and regulatory bodies
Regular production of progress reports to ethics committees, regulatory authorities and funding bodies
Budget management (and, for GSTT budgets, cost centre set-up)
Acting as a point of contact for sites participating in the clinical trial and developing effective and regular communication with key personnel for multi-centre trials
Being a key liaison with the clinical trial sponsor
Assisting central laboratories in setting up their processes in order to receive and analyse samples from clinical trial patients
Liaising with the supplier(s) of investigational medicinal product (IMP)
Working with the database developer, data manager and trial statistician to ensure systems and documentation are in place for data capture
Being a source of knowledge and advice on the clinical trial and on wider clinical research legislation and governance.
Our clinical trial managers have specific experience and expertise in overseeing first-in-man and early phase clinical trials, as well as cell and gene therapy clinical trials.
Appropriate time for clinical trial management will need to be included in your grant application.
Contact email@example.com at least four weeks before the deadline of your grant application for costing information.
Please note: Our clinical trial managers are not responsible for the clinical conduct of a trial. If you require additional clinical support, please contact our BRC.