Job summary
We are seeking a new Clinical Research Quality Assurance Manager, and there has never been a more exciting time to join us at The Royal Marsden and the Institute of Cancer Research (ICR).
What you will do:The purpose of the role is to ensure that clinical research (including clinical trials of investigational medicinal products, medical devices or other interventions; and data/tissue based clinical research studies) undertaken by The Royal Marsden and the Institute of Cancer Research fulfil the extensive legal requirements for management and delivery. The post-holder will:o Lead the clinical research quality function, with direct line management of sub-teams responsible for monitoring (Senior Monitor), auditing (Senior Auditor), quality assurance (Senior QA Officer) and pharmacovigilance (Senior PV Officer), and leadership for the entire GCP and Regulatory Compliance team.o With the Head of Clinical Research Quality Assurance, contribute to ensuring that, as far as possible, The Royal Marsden and the ICR remain 'inspection ready'. Take a key role in preparing both organisations for statutory MHRA, FDA and HTA inspections and will work towards positioning us as a leader in quality/compliance in cancer research. o Act as an expert for The Royal Marsden and the ICR for information and advice regarding clinical research quality, leveraging own knowledge and expertise, recommending and leading system change and development, and sitting on relevant committees.
Main duties of the job
The Clinical Research Quality Assurance Manager is a senior member of The Royal Marsden's Clinical Research Directorate, sitting within the Joint Clinical Research & Development Core Services. The purpose of the role is to ensure that clinical research (including clinical trials of investigational medicinal products, medical devices or other interventions; and data/tissue based clinical research studies) undertaken by The Royal Marsden and the Institute of Cancer Research fulfil the extensive legal requirements for management and delivery.
The post-holder will:
- Lead the clinical research quality function, with direct line management of sub-teams responsible for monitoring, auditing, quality assurance and pharmacovigilance, and leadership for the entire GCP and Regulatory Compliance team.
- Contribute to ensuring that, as far as possible, The Royal Marsden and the ICR remain 'inspection ready'. Take a key role in preparing both organisations for statutory MHRA, FDA and HTA inspections and will work towards positioning us as a leader in quality/compliance in cancer research.
- Act as the expert for The Royal Marsden and the ICR for information and advice regarding clinical research quality, recommending and leading system change and development, and sitting on relevant committees.
- Be responsible for leading the development and maintenance of the quality management system including policies and Standard Operating Procedures (SOPs).
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits and learning and development opportunities. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information, please refer to the Job Description/Person Specification
Quality systems
Maintain and contribute to the continued development and improvement of systems and procedures for ensuring that The Royal Marsden and the ICR are fully compliant with all relevant regulations and legislations, for example Good Clinical Practice, the Medicines for Human Use (Clinical Trials) Regulations, Human Tissue Act, General Data Protection Regulation, UK Policy Framework for Health and Social Care, etc. Research and interpret complex legislation, identifying the need for policy change and production of Standard Operating Procedures. Support the Head of Clinical Research Performance and Quality to guide the long-term strategy for research quality assurance for sites in clinical research studies and trials sponsored by The Royal Marsden and The Institute of Cancer Research, and hosted studies and trials at The Royal Marsden to ensure patient safety and data quality. Contribute to shaping and delivering advice to senior level staff including the Director of Clinical Research and the Director of Clinical Research Operations on matters relating to regulatory compliance of clinical research. Ensure that opportunities for improving consistency of quality systems across the clinical research delivery and management teams are identified and followed through. Leverage own knowledge and expertise to provide specialist advice and support to clinical research delivery and management teams and organise regular training to enable sharing of systems and good practice alongside the Head of Clinical Research Performance and Quality Ensure lessons learned from audits and monitoring are translated into changes in practice that are implemented across the complete research portfolio and research workforce.
Job description
Job responsibilities
For further information, please refer to the Job Description/Person Specification
Quality systems
Maintain and contribute to the continued development and improvement of systems and procedures for ensuring that The Royal Marsden and the ICR are fully compliant with all relevant regulations and legislations, for example Good Clinical Practice, the Medicines for Human Use (Clinical Trials) Regulations, Human Tissue Act, General Data Protection Regulation, UK Policy Framework for Health and Social Care, etc. Research and interpret complex legislation, identifying the need for policy change and production of Standard Operating Procedures. Support the Head of Clinical Research Performance and Quality to guide the long-term strategy for research quality assurance for sites in clinical research studies and trials sponsored by The Royal Marsden and The Institute of Cancer Research, and hosted studies and trials at The Royal Marsden to ensure patient safety and data quality. Contribute to shaping and delivering advice to senior level staff including the Director of Clinical Research and the Director of Clinical Research Operations on matters relating to regulatory compliance of clinical research. Ensure that opportunities for improving consistency of quality systems across the clinical research delivery and management teams are identified and followed through. Leverage own knowledge and expertise to provide specialist advice and support to clinical research delivery and management teams and organise regular training to enable sharing of systems and good practice alongside the Head of Clinical Research Performance and Quality Ensure lessons learned from audits and monitoring are translated into changes in practice that are implemented across the complete research portfolio and research workforce.
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g. BSc) in a relevant subject.
- Recognised Good Clinical Practice certification.
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject
- Project management qualification (e.g. PRINCE 2).
- People management and leadership qualification.
Experience
Essential
- Significant experience of working in an NHS or HEI environment in a quality assurance role
- Extensive clinical research experience including protocol development and implementation.
- Extensive experience and excellent skills in managing and developing staff and successfully establishing and maintaining high performing, effective teams.
- Experience of working with staff from a range of backgrounds and different levels of seniority.
- Experience of managing meetings and producing reports
- Experience of writing Standard Operating Procedures and input in developing policies
Desirable
- Experience of developing a strong culture of customer service.
- Experience of working across organisations.
- Experience of delivering training sessions.
- Experience of project management.
Skills / knowledge
Essential
- Sound knowledge of the UK Policy Framework, the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, Guidelines for Good Clinical Practice (GCP), the Human Tissue Act 2004, Data Protection Act 2018 and the Mental Capacity Act 2005, and the ability to interpret these in a non-commercial environment
- Ability to work constructively as an individual; as part of a closeknit team; and as part of a wider research community.
- Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
- Excellent change management skills. Enthusiasm for implementing change and the ability to bring fresh thinking to research processes enabling the team to develop and improve their systems
- Credibility with the academic community and external stakeholders. Ability to represent clinical research at a senior level.
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access.
- Able to lead the development and delivery of training.
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g. BSc) in a relevant subject.
- Recognised Good Clinical Practice certification.
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject
- Project management qualification (e.g. PRINCE 2).
- People management and leadership qualification.
Experience
Essential
- Significant experience of working in an NHS or HEI environment in a quality assurance role
- Extensive clinical research experience including protocol development and implementation.
- Extensive experience and excellent skills in managing and developing staff and successfully establishing and maintaining high performing, effective teams.
- Experience of working with staff from a range of backgrounds and different levels of seniority.
- Experience of managing meetings and producing reports
- Experience of writing Standard Operating Procedures and input in developing policies
Desirable
- Experience of developing a strong culture of customer service.
- Experience of working across organisations.
- Experience of delivering training sessions.
- Experience of project management.
Skills / knowledge
Essential
- Sound knowledge of the UK Policy Framework, the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, Guidelines for Good Clinical Practice (GCP), the Human Tissue Act 2004, Data Protection Act 2018 and the Mental Capacity Act 2005, and the ability to interpret these in a non-commercial environment
- Ability to work constructively as an individual; as part of a closeknit team; and as part of a wider research community.
- Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally.
- Excellent change management skills. Enthusiasm for implementing change and the ability to bring fresh thinking to research processes enabling the team to develop and improve their systems
- Credibility with the academic community and external stakeholders. Ability to represent clinical research at a senior level.
- Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams and Access.
- Able to lead the development and delivery of training.
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).
