Job summary
The post holder will be responsible for the delivery of R&D research sponsorship and co-sponsorship and the confirmation of capability and capacity of non-commercial research within the Trust, and associated research governance processes. The post-holder will also be responsible for the R&D governance and R&D performance team (17 WTE) , directly managing 5 WTE.
The post will be the Trust expert in R&D governance and sponsorshipand the related legislation required for governance approval and research management and may be required to provide expert governance advice on highly complex governance issues.
Main duties of the job
This is a research leadership role in one of the UK's busiest R&D departments, with one of the largest and diverse research portfolios. The post-hold will support the non-commercial research portfolio of our world-leading researchers and balance the setting up our studies efficiently, with the governance and regulatory requirements. The post-holder will need to be an excellent communicator to people at all levels, be able to make complex decisions and ensure the R&D governance team have systems and processes that are fit-for-purpose. The candidates will need to demonstrate significant experience in NHS research management. This role requires project management, negotiation and conflict management skills, along with pragmatism and a passion for clinical research.
About us
This is a dynamic, lively and diverse department with a high- level of research activity who look forward to welcoming a leader for the governance and performance team.
This is advertised as a full-time position but we may consider 0.8 WTE for the right candidate and are open to flexible working arrangements in line with the Trust Flexible working policy. However, the post-holder will be required to work in the R&D office at Guy's hospital a minimum of three days a week and as a senior member of the R&D office will be required to attend more frequently to support the researchers and the team during pressurised periods. The R&D office is on the 16th Floor Guy's Tower will work across all hospital sites within the organisation and across KCL campuses.
Job description
Job responsibilities
The role includes:
Management of a robust research governance management systems that ensure compliance with all relevant regulations and legislation, for example Human Tissue Act, Medicines Act, Data Protection Act, GDPR, HRA, MHRA and EMEA.
Management of R&D SOPs, Research Governance Manuals (RGMs), templates and documents under a QMS (Quality Management System) to ensure that research is compliance with the UK Policy for Health and Social Care Research.
Ensuring that all data that is collected and recorded is accurate by the R&D Governance team within the Trusts R&D Database(s)
Plan and develop R&D database and IT systems, and their integrations with Trust and JRO systems e.g. EPIC and Joint Research Office websites and other future developments.
Attract, train and retain a talented R&D Governance and Performance management team.
Job description
Job responsibilities
The role includes:
Management of a robust research governance management systems that ensure compliance with all relevant regulations and legislation, for example Human Tissue Act, Medicines Act, Data Protection Act, GDPR, HRA, MHRA and EMEA.
Management of R&D SOPs, Research Governance Manuals (RGMs), templates and documents under a QMS (Quality Management System) to ensure that research is compliance with the UK Policy for Health and Social Care Research.
Ensuring that all data that is collected and recorded is accurate by the R&D Governance team within the Trusts R&D Database(s)
Plan and develop R&D database and IT systems, and their integrations with Trust and JRO systems e.g. EPIC and Joint Research Office websites and other future developments.
Attract, train and retain a talented R&D Governance and Performance management team.
Person Specification
Knowledge/Qualifications
Essential
- Masters degree or equivalent experience
Desirable
- Project Management Qualification
Experience
Essential
- oExperience of dealing positively with organisational politics
- oSignificant experience of clinical research management, to include experience in the planning, coordination and conducting of clinical research studies or the management of clinical research.
- oEvidence of working and supporting key performance targets and delivering benefits
- oSignificant experience of leading and managing staff including HR processes and policies
Desirable
- oExperience of working in the NHS and/or academia
Skills
Essential
- oAble to take the lead and facilitate new initiatives/change
- oSignificant influencing and persuasion skills
- oExtensive knowledge of UK clinical research and its changing environment
- oEquality, Diversity and Inclusion Champion for the department
- oChampion of Research Quality and compliance
- oAttention to Detail
Person Specification
Knowledge/Qualifications
Essential
- Masters degree or equivalent experience
Desirable
- Project Management Qualification
Experience
Essential
- oExperience of dealing positively with organisational politics
- oSignificant experience of clinical research management, to include experience in the planning, coordination and conducting of clinical research studies or the management of clinical research.
- oEvidence of working and supporting key performance targets and delivering benefits
- oSignificant experience of leading and managing staff including HR processes and policies
Desirable
- oExperience of working in the NHS and/or academia
Skills
Essential
- oAble to take the lead and facilitate new initiatives/change
- oSignificant influencing and persuasion skills
- oExtensive knowledge of UK clinical research and its changing environment
- oEquality, Diversity and Inclusion Champion for the department
- oChampion of Research Quality and compliance
- oAttention to Detail
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.
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).
Additional information
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.
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).
