Senior Research Manager (Sponsorship, Hosting & Governance)
Job summary
Mid Yorkshire Teaching NHS Trust are looking to appoint a highly motivated Senior Research Manager to oversee the development of the trust's Research Management and Support Team. If you have experience of leading a research governance team and delivering support for NHS trust hosted and sponsored trials, this may be the ideal opportunity for you.
We are offering a full-time/part-time post to a suitable candidate.
The Research Team is responsible for the development of a successful and balanced portfolio of research studies across all specialities. The team comprises of more than 50 dedicated and experienced members of staff this includes researchers, research nurses, research governance, clinical trials assistants and research support staff.
Working in the research team, you will be joining a driven and caring department looking to enhance the care and treatments we offer our patients.
The successful candidate will have a keen interest in research, excellent communication, time management and organisational skills and will enjoy working with a variety of key stakeholders.
The Senior Research Manager will be responsible for ensuring the safe conduct of research at Mid Yorkshire Teaching Trust (MYTT) through the management of research governance, quality and sponsorship arrangements and the maintenance of all research projects across the Trust, working within legislative requirements.
Main duties of the job
Key Responsibilities
Research Sponsorship, Governance and Quality
- Ensure research management and support is aligned to the Trust strategic direction overall.
- Ensure that the Trust has an effective, responsive and high-quality research sponsorship function.
- Provide expertise regarding research regulatory requirements, i.e., NHS Research Ethics Committee, HRA, MHRA, ICO, FDA, Research Governance Framework, ICH-GCP, and advise accordingly.
- Manage the development of systems which enable the recording and tracking of research approval and delivery timelines in accordance with institutional and national requirements.
- Direct and provide expert advice to researchers and service departments on matters relating to research governance, ethics, regulations, set-up and research training requirements.
- Ensure an effective high-quality research governance service.
- To support researchers with any triggered audits as necessary.
- To lead on the development of a monitoring system for MYTT sponsored research studies, including overseeing audits, to ensure compliance with all applicable laws and regulations.
- Ensure that applications for sponsorship of research are managed through the system tackling any barriers to delivery.
- Manage the workload of the Research Officers, Facilitators and Administrators including allocation of studies for review.
- Ensure studies are triaged efficiently ensuring that researchers are kept informed of progress of reviews.
About us
We provide care and support to over a million people in Wakefield and Kirklees in their homes, community settings and across our three hospital sites at Pontefract, Dewsbury and Pinderfields (Wakefield).
Always striving for excellence, we are at the forefront of innovation and research, and we invest in teaching and the development of our workforce.
We live by our values of caring, improving, being respectful and maintaining high standards. We listen and learn because we aim to make Mid Yorkshire the best place to work and receive care.
We value diversity and welcome talent and enthusiasm irrespective of age, disability, neurodivergence, sex, gender identity and gender expression, race or ethnicity, religion or belief, sexual orientation, or other personal circumstances including providing unpaid carers support to someone with a health and care need. As ethnic minority groups, members of the LGBTQ+ community, and people with a disability/neurodivergence are currently under-represented across the organisation, we encourage applications from members of these groups. We have policies and procedures to ensure all applicants are treated fairly and consistently.
We are proud of our staff networks - who offer valuable guidance and feedback from those with lived experience.
We have a clear vision and you could be part of this! If you share our values and you want to make a difference to the lives of our patients and their families and carers, we would love to hear from you.
Job description
Job responsibilities
The Research Sponsorship, Hosting and Governance Manager will be responsible for ensuring the safe conduct of research at Mid Yorkshire Teaching Trust (MYTT) through the management of research governance, quality and sponsorship arrangements and the maintenance of all research projects across the Trust, working within legislative requirements including:
Utilise administrative, analytical, financial, communication and interpersonal skills together with an aptitude for developing systems and structures.
Ensure that all research carried out in the Trust complies with the UK Policy Framework for Health & Social Care Research, ICH GCP standards and best practice, including MHRA guidance.
Advise on the development of research protocols and policies for RM&S and input into policies at Trust level.
Establish, oversee and manage the Trusts Research Sponsorship function.
Work closely with external advisors to provide expert advice on research contracting and maintain the research contracting process in line with local and national expectations.
Ensure Trust-level compliance with policies and protocols.
Ensure that Research active staff within the Trust are identified, advised, and monitored according to research governance & quality assurance requirements.
Deliver training to staff of all levels, co-ordinate and advise on governance activities.
Ensure confidential research documentation and authorisation records are collated, recorded, and filed according to Trust and national policy and standards.
Support research active clinicians to develop new research proposals, including providing advice about funding sources and signposting to other sources of assistance.
Prepare where required understandable complex internal and external reports for research governance.
The postholder will work collaboratively with other research colleagues at local, regional, and national level.
The postholder will act as a resource for the Trust, advising on all matters relating to research governance, Sponsorship and contracting and the safe delivery of the Trusts research portfolio.
Any other duties commensurate with the grade and as required by the Head of Research.
Person Specification
Qualifications
- Degree.
- A higher degree Masters, MPhil or equivalent demonstrable experience of a senior QA/Governance role within clinical research.
- ICH Good Clinical Practice.
- Project Management Qualification.
Knowledge and Awareness
- In depth knowledge of the workings of external organisations and authorities relating to clinical research and clinical trials in the NHS and academia.
- An understanding of commercial research in the NHS and academia.
- Expert knowledge of the Declaration of Helsinki, and the Guidelines for Quality, Safety, Efficacy and Multidisciplinary themes developed by the International Council for Harmonisation (ICH).
- Expert knowledge of laws, regulations, and guidance pertinent to research including, but not limited to, The Medicines for Human Use (Clinical Trials) Act and UK Policy Framework for Health and Social Care Research.
- A good working knowledge of Microsoft office.
- Proven knowledge of different funding streams that exist to support NHS based research.
- Awareness of own limitations.
- Knowledge of systems and structures for the management clinical research in the NHS.
Skills and Abilities
- Strong and demonstrable interpersonal skills with an ability to communicate with a diverse range of contacts, both internal and external to the organisation.
- Excellent presentation skills.
- Ability to establish credibility throughout organisation.
- Ability to work under own initiative.
- Attention to detail and presentation of work.
- Willingness to learn, instigate and develop efficient working systems.
- Ability to work alone and as a member of a team.
- Willingness to undertake any necessary training and development to enhance work performance.
- Demonstration of self-directed development.
- Ability to prioritise conflicting and changing demands.
- Ability to take the lead and facilitate new initiatives/change.
- Flexible approach to working and a desire to develop knowledge.
- Ability to analyse and rationalise research information. Ability to make complex decisions.
- Ability to plan and organise a large workload to meet both internal and external deadlines.
Personal Attributes
- Innovative.
- Proactive.
- Projects a positive and professional image at all times.
Experience
- Extensive demonstrable experience of research governance management in the NHS, academia, or pharmaceutical industry, working to ICH GCPs.
- Demonstrable experience of IRAS submission system.
- Demonstrable experience of creating and working to Standard Operating Procedures.
- Significant experience of leading and managing staff.
- Experience of reviewing national template contracts for research.
- Experience in applying relevant legislation to the set-up of research for sponsorship and host site approvals.
- Experience of formal presentations and training, dissemination of complex, specialist information to internal and external audiences.
- Experience of delivering training to healthcare or research professionals.
- Experience of having collaborated on grant applications.
- Experience of research inspections and audits (external and regulatory authorities).
- Experience of using EDGE research management database and/or strong database skills.
Other
- Ability to travel locally, regionally and nationally.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website.
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants.
Employer details
Employer name
The Mid Yorkshire Teaching NHS Trust
Address
Pinderfields Hospital
Aberford Road
Wakefield
West Yorkshire
WF1 4DG
https://www.midyorks.nhs.uk/
- Company
- The Mid Yorkshire Teaching NHS Trust
- Location
- Wakefield, United Kingdom WF1 4DG
- Employment Type
- Permanent
- Salary
- £50952.00 - £57349.00 a year
- Posted
- Company
- The Mid Yorkshire Teaching NHS Trust
- Location
- Wakefield, United Kingdom WF1 4DG
- Employment Type
- Permanent
- Salary
- £50952.00 - £57349.00 a year
- Posted