About this role
Job summary
An exciting opportunity has arisen for an experienced research professional to join The Christie Research and Innovation Division as a Research Quality Assurance Manager. This key role supports the delivery of high-quality, safe and regulatory compliant research across the Trust Sponsored Research Portfolio.
Working within the Research Quality and Regulatory Compliance Team, you will have a specific focus on Sponsor oversight, leading the development, maintenance and continuous improvement of the Trust Sponsor Quality Management System (QMS). You will help ensure sponsored research is conducted in accordance with applicable regulations, Good Clinical Practice and organisational standards.You will deliver risk-based quality assurance activities, audits, compliance reviews and quality improvement initiatives, providing assurance that Sponsor processes remain effective and inspection ready. Working with investigators, research teams and key stakeholders, you will promote a culture of quality, continuous improvement and organisational learning.
The successful candidate will have substantial experience in research quality assurance, governance or regulatory compliance, together with a strong understanding of Good Clinical Practice, Sponsor responsibilities and quality management systems.
This is an opportunity to play a pivotal role in strengthening Sponsor oversight, participant safety and research excellence within one of the UK's leading cancer centres.
Main duties of the job
The post holder will lead the operational management of the Research Quality Management System (QMS), ensuring quality processes, documentation, audit activity, corrective and preventative actions (CAPAs), quality metrics and assurance records are maintained to a high standard. Working closely with research teams, investigators and research support services, you will promote a culture of continuous improvement, quality by design, shared learning and accountability.
You will deliver a programme of risk-based quality assurance activities, including audits, quality reviews, compliance assessments and monitoring of improvement actions. Using quality intelligence and performance data, you will identify emerging risks, trends and opportunities for improvement, providing specialist advice to support regulatory compliance and organisational assurance.
The successful candidate will have significant experience in clinical research quality assurance, governance or regulatory compliance, with excellent knowledge of Good Clinical Practice, clinical research regulations and quality management systems. You will possess strong analytical, communication and influencing skills and be able to work collaboratively with a wide range of stakeholders.
About us
The Christie is one of Europe's leading cancer centres, looking after more than 64,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 25% patients are referred to us from other parts of the country.
We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.
We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK's National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.
Job description Job responsibilities 1.0 Quality Management and Leadership
Manage the operational delivery of the Trust Sponsored Research Quality Management System. Provide specialist expertise and operational leadership in the implementation, maintenance and continual improvement of research quality management processes. Responsible for making recommendations, providing advice and able to prepare strategic reports/briefings for the Head of Department, steering/reference groups and others as required. Responsible for ensuring the coordination of change control processes within the Trust sponsored research team. Work collaboratively with research support operations and governance teams by maintaining an awareness of quality issues and contributing to problem solving to ensure the delivery of high-quality research. Implement a programme of risk-based quality assurance and assuranceactivities, including audits, quality reviews, compliance assessments andthematic reviews Responsible for leading in the conduct of third-party suppliers/vendor qualification assessments (due diligence) related to Trust sponsored studies. Seeking advice and guidance where necessary. Receive and respond to complex and occasionally sensitive research governance and reported quality related issues Recognise and act upon departures from legislative and research governance requirements, including failure to follow protocols and/or SOPs, responding appropriately and escalating action as required. Support quality reviews and investigations relating to significant quality and compliance concerns, escalating findings appropriately in accordance with Trust procedures. Provide guidance to research operations/governance teams on the interpretation of corporate and regulatory requirements (standard/policies/procedures) related to quality assurance and GCP. Maintain accurate quality management records that are ready for inspection by regulatory authorities on demand. Support the implementation and ongoing evaluation of risk-based quality management approaches across the Trust sponsored research portfolio. Contribute to the identification and review of critical-to-quality factors and quality risks throughout the research lifecycle. Maintain oversight of quality events, deviations, audit findings, CAPAs, lessons learned and compliance trends across the sponsored portfolio. Monitor quality metrics and key performance indicators and provide reports to support organisational assurance. Ensure controlled documents are reviewed and maintained in accordance with document governance requirements. Support the implementation and monitoring of risk-based quality management processes across the sponsored research portfolio.
2.0 Service Improvement /Policy Development To develop and implement business processes and Standard OperatingProcedures to ensure that the Trust conforms to the requirements of relevant legislation. Responsible for interpreting, proposing and drafting changes to policies, guidelines and service level agreements (SLAs) which impact the service. Maintain a good knowledge of emerging policies from government departments and external bodies which may impact the service. Promote Quality by Design principles through the development, review and continual improvement of quality systems and research processes Contribute to strategic and contingency planning for the service, which may have an impact on other areas. Foster an environment for continuous improvement through ensuring that lessons learned through audits and inspections are shared within the Department and beyond as necessary. Provide regular reports on quality trends, compliance risk, observations and suggestions to senior management as necessary. Work collaboratively with Research Governance, Sponsorship, Research Delivery and Support Services to identify and implement quality improvement priorities arising from audits, compliance reviews, quality metrics and lessons learned.
3.0 Risk Management Support the departmental lead in ensuring that risk registers are effectively managed and maintained within the Division by ensuring effective processes are implemented for the review of risks within the Trust sponsored research function Maintain oversight of quality and compliance risks identified across the Trust sponsored research portfolio, ensuring appropriate escalation and monitoring through established governance processes.
4.0 Communication Provide, receive and analyse highly complex, sensitive and contentiousinformation and make judgements based on the information. Present complex information to a wide range of stakeholders in formal and informal settings. Responsible for providing management reports on Quality Management activities to departmental, Divisional and Trust Governance groups, as required. Present audit findings, compliance trends and quality improvementrecommendations in a constructive and solutions-focused manner. Develop effective working relationships with investigators, research teams and support services to promote engagement with quality improvement activities. Produce routine and ad hoc quality assurance reports for governance groups and senior stakeholders Committed to working and engaging constructively with internal and external stakeholders on a range of business sensitive issues Maintain strong relationships and positive communication channels with other key personnel. Develop and establish research relationships with key partners including academia, NHS and commercial companies. Represent the Research Quality, Assurance and Regulatory Compliance team at relevant quality. Regulatory and governance forums as delegated.
5.0 People Management and Development Provide professional support, coaching and subject matter expertise to research staff in relation to quality management systems, Good Clinical Practice, audit readiness and compliance requirements. Where required, supervise designated staff, trainees or project-based quality resources. Influence, support, co-ordinate and take the initiative to obtain co-operation or agreement to alter ways of working, particularly where the need for change cannot easily be identified. Provide leadership and standards of best practice, promoting ethical and professional practice throughout the organisation Provide specialist advice to internal and external investigators/ collaborators in the planning of compliant clinical research. Considering the advice of functional leads, determine the quality system training needs of staff in relation to quality systems, deliver area specific training ensuring that there are mechanisms for effective oversight to facilitate departmental and functional leads in ensuring that all staff members are trained appropriately.
6.0 Learning and Development Ensure own professional knowledge is regularly updated and keep abreast of relevant developments, making effective use of learning opportunities and actively promoting the workplace as a learning environment. Maintaining and developing knowledge of national and local clinical and research quality initiatives Participate in personal objective setting and review, including the creation of a personal development plan. Actively seek mentorship/supervision/coaching to enable reflection and own personal development within the role. Committed to working and engaging constructively with internal and external stakeholders on a range of business sensitive issues
Person Specification
Qualifications Essential
First degree in life sciences discipline or equivalent specialised professional experience
Desirable
Post graduate qualification in related discipline Evidence of Continuing Professional Development
Experience Essential
Previous experience in the management of quality assurance and / or regulatory compliance in a research setting within the NHS or Academic setting Experience of writing quality System policies and procedures Experience in implementation of GCP
Desirable
Experience of developing strategies, policies, and business plans
Skills Essential
Ability to assess and interpret highly complicated and conflicting information and use judgement where appropriate Excellent verbal, written and presentation skills Possess developed persuasive, motivational, negotiating, empathic or re-assurance skills Ability to write and present complex reports and to critically analyse and communicate ideas in complex situations Good organisational and time management skills Excellent cross disciplinary / interagency communication skills and ability to facilitate collaborative working relationships Ability to influence and negotiate others in a challenging environment IT, information, project and time management skills Ability to deal with difficult / sensitive situations Ability to work as part of a team, demonstrated coaching/mentoring skills, good problem resolution skills Able to develop and deliver staff training programmes and conference presentations Highly developed problem-solving skills and ability to respond to sudden unexpected demands Must be able to use initiative to decide relevant actions and make recommendations to Sponsor/Manager, with the aim of improving deliverables and compliance to policies Strategic thinking - ability to anticipate and resolve problems before they arise
Knowledge Essential
Detailed knowledge of ICH E6(R3) Good Clinical Practice principles Knowledge of UK Clinical Trials Regulations and associated guidance Knowledge of Quality Management Systems and quality assurance methodologies Knowledge of risk-based quality management principles Knowledge of CAPA management and root cause analysis methodologies Knowledge of audit, assurance and inspection processes Understanding of sponsor responsibilities within NHS sponsored research Knowledge of research governance frameworks applicable to clinical research
Desirable
Knowledge of NHS R&D Strategy and NHS research agenda Experience of risk management Knowledge of Quality by Design principles Knowledge of electronic quality management systems Knowledge of computerised systems and data integrity principles
Values Essential
Ability to demonstrate the organisational values and behaviours
Other Essential
Strong Personal integrity Innovative and positive approach Flexible and motivated team player Occasional travel to other sites Elevated level of emotional intelligence
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 The Christie NHS FT
Address R&D Office - Q01552
Manchester
M20 4BX
United Kingdom
Employer's website https://www.christie.nhs.uk/ (Opens in a new tab)