About this role
Job summary
The post of Senior Research Portfolio Manager (SRPM) is part of the Gloucestershire Hospitals NHS Foundation Trust (GHFT) Research, Innovation and Genomics (RIG) Department which provides advice and support to researchers across the Trust to help them design and set-up studies, navigate various approvals processes and deliver high quality research to local and national performance management targets. The SRPM is responsible for the end-to-end set-up, costing, governance, and on-going management of a portfolio of commercial and non-commercial research studies and service evaluations across a wide range of disciplines. The postholder will coordinate between researchers, sponsors, supporting departments, research delivery team, and external bodies to ensure studies are initiated efficiently, compliantly, and within agreed timelines, meeting the National Institute for Health and social care Research (NIHR) key performance metrics, and the Trust's strategy and performance targets.
The postholder will also lead the monitoring of performance of open studies not supported by the research delivery team to ensure key performance indicators are met whilst being compliant with the UK research regulations, and support the Research Matron, and Team Leads with this work for studies being managed within the research delivery team.
The proposed interview date is 25th June
Main duties of the job
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.
Key Knowledge and Experience
Degree in science, research, or management related field, or equivalent.
Equivalent being a combination of professional qualifications and substantial, relevant experience at graduate level complexity.
Research and/or research management skills in a healthcare setting.
Proven track record of study set-up within the NHS.
Detailed knowledge and understanding of clinical trials regulations and research governance policies.
Knowledge and understanding of the current Health Research Authority (HRA) approval processes, including Research Ethics Committees (REC) and Medicines and Healthcare products Regulatory Agency (MHRA).
Experience of NIHR systems and processes, such as model agreements, National Contract Value Review (NCVR) and the research passport system.
Knowledge and experience of capacity and capability processes for research and service evaluations.
Working knowledge of research design and methodology.
Excellent IT skills
Ability to manage a continually changing portfolio of studies with different, often competing requirements
About us
GHFT Research, Innovation, & Genomics is a friendly and supportive department committed to providing an excellent service to researchers, Trust staff, and patients, providing resources, knowledge, and opportunities to drive forward research within Gloucestershire and beyond.
Job description Job responsibilities
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)
07815 978323
Monday to Friday 8 -4
Person Specification
Qualifications Essential
Degree in science, research, or management related field, or equivalent. Equivalent would be a combination of professional qualifications and substantial, relevant experience at graduate level complexity.
Knowledge and skills Essential
Detailed knowledge and understanding of clinical trials regulations and research governance policies. Knowledge and understanding of the current Health Research Authority (HRA) approval processes, including Research Ethics Committees (REC) and Medicines and Healthcare products Regulatory Agency (MHRA). Working knowledge of research design and methodology. Excellent IT skills Well-developed interpersonal skills Able to communicate with people at all levels of the organisation Well-developed organisational skills
Experience Essential
Research and/or research management skills in a healthcare setting. Proven track record in study set-up within the NHS. Knowledge and experience of capacity and capability processes for research and service evaluations. Experience of NIHR systems and processes, such as model agreements, National Contract Value Review (NCVR) and the research passport system. Proven experience of working on own initiative and as part of a team.
Personal Attributes Essential
Ability to manage a continually changing portfolio of studies with different, often competing requirements Ability to manage conflicting demands on time and resources Ability to manage frequent interruptions to concentration from people, telephone, etc. Able to concentrate for long periods of time on often lengthy documents.
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details Employer name Gloucestershire Hospitals NHS Foundation Trust
Address Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire
GL1 3NN
United Kingdom
Employer's website https://www.gloshospitals.nhs.uk/ (Opens in a new tab)