Research Governance Manager

Job description

Job responsibilities

Operational Management

Direct responsibility for the operational development and effective delivery of high performing and facilitative teams for research sponsorship, quality assurance and clinical trial management and archiving.

Leading on readiness and delivery of regulatory inspections

Advise the R&D Directors and implement robust performance and governance arrangements across the Trusts R&D functions and embed clear mechanisms for Trust oversight.

Take operational accountability, with the R&D Directors, for all aspects of the R&D functions, adopting a flexible approach in order to deliver the research governance and quality assurance year-on-year business plans.

Encourage and facilitate an inclusive quality approach to research, ensuring that all aspects of the Trusts research portfolio are supported as required.

Work collaboratively with and provide expert advice to partner organisations as required.

Advise the R&D Research Advisor on major funding applications from internal and external sources.

Advise on the appropriateness of Trust sponsorship for Own account research.

Represent the UHP R&D functions locally, nationally and internationally as appropriate, fostering external relationships and collaborations with other research institutions and commercial partners as appropriate.

Establish, develop, and maintain the appropriate operating infrastructure for the research sponsorship, and trial monitoring functions, ensuring the recruitment and retention of appropriate staff.

Human Resources

Direct responsibility for the research sponsorship, and trial management within the Trusts R&D functions, working with the Directors to provide credible, visible, and authoritative operational leadership.

Be the professional managerial lead for staff within the research sponsorship, archiving and trial monitoring functions, providing mentorship, development and creating a learning culture, built on effective communication, and being recognised as a role model.

Promote appropriate skills mix, the development of new roles and multi - and cross-disciplinary working with the research sponsorship, quality assurance and trial monitoring functions as appropriate to operationally support the research strategies.

Fully line manage research sponsorship, quality assurance and trial management staff including individual performance management, appraisal, and development of staff to optimise individual and organisational performance.

Responsible for developing plans to ensure effective team building across the research sponsorship, and trial monitoring teams and functions within the department is established to create a productive and facilitative working environment.

Ensure all staff have access to continuing professional education and development, to optimise individual and team performance in delivering on the strategic objectives within the research sponsorship, quality assurance and trial management.

Responsibility for managing staff conflict resolution and complaints.

Ensure all research sponsorship, quality assurance and trial monitoring staff comply with the Trusts standing financial instructions and other Trust policies and procedures.

For further details please see the attached JD & PS

Person Specification

Qualifications

Essential

• Degree in a clinically relevant scientific subject.
• A higher degree Masters, MPhil or significant demonstrable experience of a QA/Governance role within research.

Desirable

• Project Management qualification
• Leadership Qualification

Knowledge & Experience

Essential

• oExtensive demonstrable experience of research governance management in the NHS, academia, or pharmaceutical industry, working to ICH GCPs.
• oIn depth proven knowledge of the workings of external organisations and authorities relating to clinical research and clinical trials in the NHS and academia.
• oAn understanding of commercial research in the NHS and academia.
• oA good working proven knowledge of the Declaration of Helsinki, and the Guidelines for Quality, Safety, Efficacy and Multidisciplinary themes developed by the International Council for Harmonisation (ICH).
• oA practical proven 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.
• oA good working proven knowledge of Microsoft office.
• oDemonstrable experience of IRAS submission system.
• oDemonstrable experience of creating and working to Standard Operating Procedures.
• oMember or Fellow of Research Quality Association or equivalent
• oDemonstrable experience of Phase 1 Clinical Trials and their complexity
• oProven knowledge of different funding streams that exist to support NHS based research

Desirable

• oDemonstrable budget management experience
• oDemonstrable commercial experience working across organisations
• oDemonstrable experience within strategic development within a healthcare setting
• oGood understanding of R&D strategy within healthcare setting
• oDemonstrable experience of supporting business case development

Aptitude & Abilities

Essential

• oStrong and demonstrable interpersonal skills with an ability to communicate with a diverse range of contacts, both internal and external to the organisation.
• oExcellent presentation skills.
• oAbility to establish credibility throughout organisation.
• oAbility to organise and prioritise own and others workload and work to tight deadlines.
• oEffective change management skills.
• oProjects a positive and professional image at all times.

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.

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 (Opens in a new tab).

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 (Opens in a new tab).

Employer details

Employer name

University Hospitals Plymouth NHS Trust

Address

Research and Development

17 Research Way, Plymouth Science Park

Plymouth

PL6 8BT

Employer's website

https://www.plymouthhospitals.nhs.uk/ (Opens in a new tab)