Trial Manager

For further information on this role, please see the attached detailed Job Description and Person Specification: Contribute to clinical trial design, protocol development and funding applications together with Chief Investigator (CI), statistician and other members of the team. Preparation of and continual update of essential trial documentation in collaboration with CI, other members of the team, other departments at the Royal Marsden and other organisations as applicable. Complete and submit initial applications and amendments to internal Sponsor committee (CCR), REC and MHRA and other organisations as required for the clinical trial. To be the main point of contact for participating sites in multi centre studies ensuring appropriate assessment of site feasibility for trial participation, planning site initiation visits and ensure sites have all applicable documentation in place. To have oversight of clinical trial activity and conduct of designated clinical trials. Manage systems for
tracking trial conduct, such as ensuring recruitment and data entry targets are met and checking stock of IMP at sites. Coordinate supply and provision of any clinical trial equipment or supplies and ensure these are available as required. Contribute to design and validation of the database for each study, working with the statisticians and programmers. Ensure that Trial Master File (TMF) and Investigator Site Files (ISF) are correctly set-up and maintained. Coordinate set-up and running of trial oversight committees and regular meetings to plan and manage the studies, including preparing the agenda and meeting papers and writing minutes. Ensure that processes for receiving and processing Serious Adverse Event (SAE) and SUSAR reports are correctly followed to the required timelines. Ensure trial specific monitoring plans are created and adhered to, working with the statisticians and monitoring team. Plan and perform site initiation visits, and other monitoring visits as required. Contribute
to preparation and submission of safety reports, progress reports, manuscripts, abstracts and posters.