Senior Research Portfolio Manager, Band 6

Key Responsibilities - To ensure all research, innovation projects, and service evaluation hosted and/or sponsored by Gloucestershire Hospitals NHS Foundation Trust complies with all relevant national legislation and guidance and meets performance management targets set by the NIHR in terms of set-up and recruitment. - To support the Research Matron, Delivery Team Leads, local delivery teams, and Principal Investigators to identify, set-up, review, and confirm Capacity and Capability for all NIHR studies hosted by Gloucestershire Hospitals NHS Foundation Trust. - To ensure that research costs are evaluated, escalated as per the NCVR if commercial, and a plan developed for study related finances and its appropriate distribution. - To liaise with sponsors, Chief Investigators and students to support the review and set-up of non-portfolio studies. - To liaise with Sponsors to negotiate contracts on behalf of the Trust and research teams. - Understanding clinical trial protocols and identifying potential risks, obstacles and governance issues that may impact on the Trusts integrity. - To check and assess service support requirements for potential studies - To liaise with local support departments, such as Pharmacy, Pathology and Radiology where necessary for confirmation of Capacity and Capability. - To work closely with the research delivery team to ensure timely set-up and review of studies, ensuring all required study documentation is complete prior to opening. - To deliver the requirements of the NIHR Research Passport system, identifying the need for Honorary Contracts and Letters of Access as necessary. - Responsible for the management of study Expressions of Interest to develop the local NIHR study portfolio. - To ensure the clinical trials IT system workflows are completed fully and in a timely fashion during the review process. - Ensure research data is of a consistently high standard of quality and accuracy. Professional Development, Education and Training - Responsible for maintaining own professional development, education and training as required for the role. - Maintain up-to-date Good Clinical Practice training - Maintain expert knowledge in research governance legislation and UK research standards. - Able to keep up to date with changing clinical trials regulations and interpreting the regulations for use in local practice Management and Leadership - Line management and supervision of the Research Portfolio Manager role - Participation in the training of RIG and wider Trust staff in research and innovation related topics. Provide expert advice to researchers. - Expected to extract, interpret and communicate data and present this within the RIG department, wider Trust and to external organisations and the public. - To attend local, regional, and national meetings as required, presenting local activity data as necessary. - To ensure that relevant information is flagged to the RIG Senior Management Team so that it can be distributed through the communications channels. This may include writing articles or updating website information as required. Planning and Organisation - To take the lead for the ongoing research governance function of their portfolio of studies. This will include developing action plans from external audit reports, internal audit and monitoring of active studies, both hosted and sponsored, to ensure continued compliance with all relevant national legislation and guidance as well as local Standard Operating Procedures. - To take the lead on performance management for their portfolio of studies to ensure delivery to time and target. Liaising with the relevant Principal Investigators and research teams to ensure early identification of potential difficulties with meeting agreed targets and working with them to put an action plan in place. - To be responsible for ensuring that study related finances are monitored and invoices are raised in a timely manner - To be responsible for monitoring locally sponsored studies under the guidance and request of the Quality Assurance Manager. Communications and Working Relationships - The post-holder will be expected to communicate with a variety of stakeholders at all levels including but not limited to National Clinical Trials Units, Pharmaceutical companies, and other research Sponsor organisations, Regional Research Delivery Network (RRDN) staff, researchers, support service staff and clinicians both within Gloucestershire Hospitals NHS Foundation Trust and beyond. - The ability to work to, and meet, tight deadlines while retaining attention to detail. - Well-developed interpersonal skills - Well-developed organisational skills - Proven experience of working on own initiative and as part of a team. - Able to communicate with people at all levels of the organisation - Ability to foster good working relationships with key trust research staff, departments and partners to further support the Trusts research portfolio and objectives - Ability to manage challenging situations Other - To support the coordination of activity data returns to the South West Central RRDN and the NIHR as required. - Ensure the secure handling of personal and sensitive data. - Contribute to the writing, implementing and monitoring of the Trusts research Standard Operating Procedures where required. - To work with the Professional Services Manager and Commercial Trials Unit Manager to identify new ways of working to improve local systems and compliance with the NIHR performance metrics. - Assist in implementing and monitoring South West central RRDN procedures and processes. - Supporting the RIG Senior Management Team and the wider RIG department. - To take on other duties as required or assigned which are reasonably within the scope of the duties in this role Contact Details Lauren Bull (Commercial Trials Unit Manager) lauren.bull2@nhs.net 07815 978323 Monday to Friday 8 -4