Job summary
Do you want to be part of our journey to research excellence as a University Hospital Trust and a leader in commercial clinical trials in Lancashire & South Cumbria? Join us to contribute to our expansive Research & Innovation Strategy. Upholding the Trust's values, you will lead the Research and Development administrative functions of the Centre of Research and Innovation, supporting our teams in research governance, data science, finance, and industry liaison.
You will have expert knowledge of research governance, regulatory frameworks, and performance metrics, providing trial sponsorship oversight. Leading the Research Access and finance teams, you will ensure our research study portfolio, including commercial clinical trials, meets the highest regulatory standards. This includes supporting our Head of Clinical Research Operations in maintaining our NIHR Lancashire Clinical Research Facility as a centre of excellence for early phase clinical trials and cancer vaccines.
As part of the senior leadership team, you will collaborate with Directors and the Deputy Director to expand the commercial portfolio, specifically establishing the BioNTech Partnership with LTHTr.
Please note interviews are planned to take place on 17th July, subject to panel availability.
Main duties of the job
Supporting our Quality Lead, you will oversee the Research Quality agenda, including Risk Management and Trust Monitoring and Audit programmes, ensuring regulatory compliance and high-quality research. You will report to Trust Committees, Boards, and the Department of Health and Social Care, and the NIHR.
Duties include:
- Is responsible for ensuring the administrative team are adequately supported and developed to deliver their roles
- Workforce Planning
- Leading & developing the team by being a visible and strong role model providing leadership & direction to the team,
- Research Quality Agenda
- Lead the research sponsorship processes to ensure all LTHTr sponsored research studies and clinical trials comply with regulatory responsibilities
- Take an active role in business planning as part of the senior management team
- Work with the Senior team to develop the research strategy
- Maintain high standards in governance, set-up, initiation, and delivery and continually identify and implement service improvement programmes.
- Work closely with NIHR Regional Research Development Network (RRDN)
- Deputise for Deputy Director of Research and Innovation.
- Provide advice & support to other members of the multidisciplinary team with regard to GCP, ethics approval and amendments, study set up, delivery & completion
- Involved in promoting the work of the Centre for Health Research and Innovation
About us
The Centre for Health Research & Innovation (CHRI) has a team of approximately 70 staff made up of research nurses, clinical trial support officers and data managers. A key part of this is the Research Access Team - that is, the research governance and industry teams who are here to support our staff with the set-up of your research studies. They work alongside our delivery and clinical teams to set-up studies, liaise with external Sponsor organisations and ensure that all regulatory and governance requirements are in place prior to opening studies.
CHRI is therefore a multidisciplinary team. We work in a supportive environment in our dedicated spaces across the Trust. We promote key behaviours of Humility, Team First, being Committed and being Aspirational in all of our staff. As we write the team is restructuring from 6 clinical teams to essentially 2, but still essentially across a number of therapeutic areas notably cancer, neurosciences, trauma and acute conditions, respiratory, renal, chronic conditions and across the women and children's spectrum. We encourage flexibility and mutual support.
Job description
Job responsibilities
The detailed job description and main responsibilities are attached to this TRAC request.
Role summary:
To provide leadership for the Research and Development administrative functions of the department and provide support and guidance to administrative teams. Having highly specialised and expert knowledge and understanding of research governance requirements, regulatory frameworks, performance metrics and sponsorship issues in relation to clinical research, the Head of Research and Development is responsible for:
- Management and oversight of the Trust research study portfolio including commercial clinical trials.
- Providing feedback and reports to several Trust Committees and Boards
- Overall responsibility for research Quality, including the Research Safety & Quality Agenda, Risk Management and Trust Monitoring and Audit programme, ensuring regulatory compliance and the delivery of high-quality research across the portfolio of active studies.
- Producing and reporting quarterly and annual reports as required by the Department of Health and Social Care, and the National Institute for Health and Care Research (NIHR).
- Management of the clerical team.
- Comprehensive financial management and performance reporting within the research department.
- Collaborating closely with the Deputy Director and Head of Clinical Operations to drive the expansion of the commercial portfolio (and within this specifically helping to verse the BioNTech Partnership with LTHTr) ensuring alignment with the trust's strategic objectives and fostering a culture of leadership and financial growth within the teams.
- Leading and developing administrative staff by being a visible authoritative role model providing managerial leadership, support and supporting staff to reach their full potential.
- Contributing to the development of research strategy and work programmes.
- Planning and organisation of complex activities across the entire theme portfolio in collaboration with other professionals and agencies
- Sponsorship responsibilities, processes and activities within the Trust pertaining to Trust sponsored studies.
Job description
Job responsibilities
The detailed job description and main responsibilities are attached to this TRAC request.
Role summary:
To provide leadership for the Research and Development administrative functions of the department and provide support and guidance to administrative teams. Having highly specialised and expert knowledge and understanding of research governance requirements, regulatory frameworks, performance metrics and sponsorship issues in relation to clinical research, the Head of Research and Development is responsible for:
- Management and oversight of the Trust research study portfolio including commercial clinical trials.
- Providing feedback and reports to several Trust Committees and Boards
- Overall responsibility for research Quality, including the Research Safety & Quality Agenda, Risk Management and Trust Monitoring and Audit programme, ensuring regulatory compliance and the delivery of high-quality research across the portfolio of active studies.
- Producing and reporting quarterly and annual reports as required by the Department of Health and Social Care, and the National Institute for Health and Care Research (NIHR).
- Management of the clerical team.
- Comprehensive financial management and performance reporting within the research department.
- Collaborating closely with the Deputy Director and Head of Clinical Operations to drive the expansion of the commercial portfolio (and within this specifically helping to verse the BioNTech Partnership with LTHTr) ensuring alignment with the trust's strategic objectives and fostering a culture of leadership and financial growth within the teams.
- Leading and developing administrative staff by being a visible authoritative role model providing managerial leadership, support and supporting staff to reach their full potential.
- Contributing to the development of research strategy and work programmes.
- Planning and organisation of complex activities across the entire theme portfolio in collaboration with other professionals and agencies
- Sponsorship responsibilities, processes and activities within the Trust pertaining to Trust sponsored studies.
Person Specification
Qualifications & Education
Essential
- Masters degree in relevant subject or demonstrable experience
- Management/Leadership qualification
- Postgraduate qualification in a relevant subject or demonstrable experience
- Evidence of continuous professional development
Desirable
- NIHR Leadership Qualification
- PhD
Knowledge & Experience
Essential
- Significant experience of research and development delivery; and experience of working at a senior management level
- Staff/Line management experience
- Experience of linking to Senior Organisational leaders including Execs/CEO
- Significant knowledge of clinical/research governance/national research policy framework
- Specialist professional knowledge of research management acquired through a degree or equivalent experience in NHS, HEIs or Industry
- Comprehensive knowledge of Good Clinical Practice and other legislative requirements such as Human Tissue Act and the application of legislation into practice
- Experience of analysing and presentation of complex data streams
- Experience of clinical research management at a senior level for the conduct of clinical research studies in accordance with the UK Policy Framework for Health and Social Care Research and applicable UK regulations, including oversight of commercial clinical trials
Desirable
- Extensive knowledge of clinical services/clinical experience
- Experience of change management and continuous improvement
- Project management experience
Person Specification
Qualifications & Education
Essential
- Masters degree in relevant subject or demonstrable experience
- Management/Leadership qualification
- Postgraduate qualification in a relevant subject or demonstrable experience
- Evidence of continuous professional development
Desirable
- NIHR Leadership Qualification
- PhD
Knowledge & Experience
Essential
- Significant experience of research and development delivery; and experience of working at a senior management level
- Staff/Line management experience
- Experience of linking to Senior Organisational leaders including Execs/CEO
- Significant knowledge of clinical/research governance/national research policy framework
- Specialist professional knowledge of research management acquired through a degree or equivalent experience in NHS, HEIs or Industry
- Comprehensive knowledge of Good Clinical Practice and other legislative requirements such as Human Tissue Act and the application of legislation into practice
- Experience of analysing and presentation of complex data streams
- Experience of clinical research management at a senior level for the conduct of clinical research studies in accordance with the UK Policy Framework for Health and Social Care Research and applicable UK regulations, including oversight of commercial clinical trials
Desirable
- Extensive knowledge of clinical services/clinical experience
- Experience of change management and continuous improvement
- Project management experience
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).
