The Trial Manager will coordinate multifunctional team(s) consisting of clinician(s), statistician(s), database programmer, data manager/clinical trial assistant to project manage one or more complex clinical trials throughout their lifecycle. This may include input into protocol development, study set-up (including regulatory approvals), ongoing study management, closeout and reporting for University Hospitals Plymouth NHS trust Sponsored/Hosted research. Working with the support of the Senior Leadership Team, the post holder will ensure that all trials are conducted to the relevant clinical trial regulations.
Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.
For more information, please contact:
Muchi Kanengoni
R&D Governance Manager
* The Project Officer is responsible for operational and management aspects of a suite of Research and Development (R&D) strategic projects from inception to completion.
* The post holder is required as appropriate to provide leadership and involve other members of the wider R&D Directorate to fulfil the remit of individual projects.
* The post holder will function as an expert resource, first point of contact and on-going liaison for all R&D stakeholders involved with the management of strategically directed projects.
* The post holder will be expected to produce clear project plans, trackers and updates to the R&D Senior Management team. They will be responsible for notifying of any slip in progress and recommendations for required action.
We are a people business – where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment manager for this post who will put you in touch with the recruitment team. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Trial set-up and initiation
* Coordinate the set-up and conduct of clinical trials and clinical research projects.
* Contribute to clinical trial design, protocol development and funding applications together with CI, statistician and other members of the team, under the supervision of Senior Trial Managers and Project Managers members.
* Input into clinical trial protocols, prepare funding applications for new study proposals and support the preparation of clinical trial budgets, under the supervision of the senior team members.
* Contribute to preparation of essential clinical trials documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), Senior Trial Manager, Clinical Fellow etc
* Contribute to preparation of trial documentation e.g. trial guidance notes, case report forms (CRFs), monitoring plans, in collaboration with relevant members of the Trial Management team including the CI, clinical fellow (where relevant) Clinical Trial Database Programmer (CTDP) and Statistician.
* Contribute to preparation and submission of applications for ethics, regulatory, Sponsor, and other approvals that may be required in order to conduct the clinical trial.
* Ensure all the required approvals and agreements are in place before the trial opens to recruitment.
* Ensure clinical supplies or equipment are available and distributed appropriately
* Set-up trial specific procedures including monitoring plans in accordance with UHP (in it's capacity as Sponsor) SOPs to ensure the efficient management of the trial
* Set-up up electronic Trial Master File and support research sites in the setup and maintenance of electronic Investigator Site Files.
* Coordinate set-up of trial oversight committees and charters in collaboration with CI, statistician and other members of the team for Sponsored studies.
* Plan and perform site initiation visits ensuring sites have all applicable documentation in place and that principal investigators and site staff understand the protocol and their responsibilities within the trial
For further details please see attached JD and PS