Quality Manager

at  Kings College London

Job id: 088625. Salary: £62,696 to £71,857 per annum, including London Weighting Allowance.
Posted: 29 April 2024. Closing date: 19 May 2024.
Business unit: Research Management & Innovation. Department: KHP Clinical Trials Office.
Contact details: Ann-Marie Murtagh. ann-marie.murtagh@kcl.ac.uk
Location: Guy’s campus. Category: Professional & Support Services.
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Job description
The QM is responsible for the KHP-CTO Quality Team which consists of:
Senior Clinical Research Associates and teams of CRAs & CTAs
Senior Clinical Trials Training Executive and team of CTTEs
The post-holder will be responsible for the development, implementation and maintenance of robust systems and processes for Quality Assurance, driving a quality approach to the conduct of commercial and non-commercial clinical trials conducted within Kings Health Partners (KHP) The post holder will take an active role in providing advice on all aspects of Governance & Quality Assurance, including regulatory advice.
The post holder will be responsible for the data and safety Quality Management systems, ensuring effective arrangements are in place, via a comprehensive suite of SOPs, to ensure that all research projects are conducted according to current regulatory and quality standards and that all trial teams are working to an “inspection ready” status
This post will be offered on an indefinite contract.
This is a full-time post - 100% full time equivalent (35H).
Key responsibilities
To work closely with the Clinical Trials Office Director to ensure that the KHP-CTO policies meet the legal obligations of the partner institutions when acting as sponsor or co-sponsor of clinical trials and regulatory and best research practice requirements are translated into robust, workable processes.
Develop, implement, maintain and monitor appropriate risk based quality systems to ensure regulatory compliance throughout the life-cycle of studies.
Develop Quality Assurance (QA) and Governance procedures to support study initiation, study implementation, study conduct, study close down and archiving, which will ensure that study participants and data are safeguarded in compliance with applicable regulatory requirements and recognised standards.
To manage the submission, maintenance and reporting of clinical trials with regard to regulatory requirements for non-commercial trials where one or more of the partner institutions is sponsor or co-sponsor. This will include the preparation of CTA applications, substantial amendments and pharmacovigilance reporting.
In collaboration with other senior R&D and governance staff across the partner institutions, to ensure the prevention, detection and management of clinical research fraud, malpractice and misconduct.
To collaborate with R&D teams across the partner institutions and the Commercial Trials Manager to develop and implement a robust feasibility process to ensure successful recruitment to trials.
To maintain expertise in prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.
To provide advice on regulatory and quality matters to those wishing to conduct clinical trials across the partner institutions.
Lead preparations for mandatory inspection of any of the KHP Partners by regulatory bodies including the MHRA, Human Tissue Authority (HTA), US Federal Drug Agency (FDA), European Medicines Agency (EMA)and Care Quality Commission (CQC) developing and maintaining an inspection readiness and implementation plan, in order to ensure that the Trusts services and research staff remain in a state of readiness for statutory inspection.
To host sponsor audits on behalf of the Partner institutions
To develop and maintain key performance Indicators and tools to permit day to day management of the quality team and provide activity overviews of the Partner sponsored clinical trials to the KHP-CTO Director.
To put in place a dashboard and reporting system to the Partner Organisations to demonstrate that the sponsor responsibilities delegated to KHP CTO are being robustly actioned
To develop and operationalise an escalation SOP between KHP CTO and Partner organisations
Introducing and overseeing systems and processes to maintain high standards of data collection and quality, ensuring that high quality data is collected within KHPCTO and Partners receive regular reports and KPIs for all aspects of delegated sponsor responsibilities
To lead on high level investigations, providing advice and guidance on incident reporting, plus any required remedial actions
Communication & Networking
To work with the Commercial Trials Manager and Director to ensure smooth, cohesive day to day management of the KHP-CTO.
To work with academic and clinical investigators and their trial teams across the partner institutions to identify and broker solutions to impediments to conducting quality non-commercial trials.
To liaise and work with colleagues within KCL RMID and the Trusts’ R&D teams to ensure clinical trial operations across the Partner Organisations is cohesive.
To act as an ambassador for the KHP-CTO.
To have in place a robust escalation pathway to the Partner R&D departments
Decision Making, Planning and Problem Solving
To provide expert support to the Director to promote a quality approach to the conduct of commercial and Partner sponsored non-commercial clinical trials to all staff involved in the set up and administration of clinical trials across the partner institutions by ensuring the :
Identification and resolution of problems: logistical, methodological, human and technical.
Management of trial related issues
Expert and regularly updated knowledge of regulations and compliance issues
Team Work, Teaching & Learning Support:
To lead the KHP CTO Quality team and work flexibly as a member of a team.
Conduct appraisals and ensure professional development of direct reports and to support direct reports in the management of their teams.
Update KHP-CTO staff on developments within the Partnersand the wider research environment.
Ensure all Quality Team staff understand KHP’ CTO’ vision and are suitably trained to fulfil their roles.
To act as manager, coach, mentor and facilitator to Quality Team staff; new and existing.
Supporting career development of team members.
Skills, knowledge, and experience
Knowledge

Essential

• Good Clinical Practice (GCP) training
• Comprehensive knowledge and understanding of standards and legislation that govern research in the NHS
• Comprehensive knowledge of clinical trial regulations, good clinical practice guidelines and other regulatory frameworks and their implication for health research.
• Educated to post graduate (Master’s degree) level in health/health related area or equivalent professional experience

Desirable

• Quality Assurance/ Governance related professional qualifications
• Knowledge of the NHS RD agenda

Experience

Essential

• Extensive Research experience in clinical/health service environment
• Proven experience of working within a quality assurance role, either within academia, the NHS or the pharmaceutical industry
• Significant Experience of supporting third party or internal audits and/or monitoring visits and developing audit/monitoring plans and CAPAs
• Experience of Policy/SOP development
• Experience of managing risk based systems

Desirable

• Extensive Experience of clinical trial monitoring and/or audit.
• Experience supporting regulatory inspection
• Experienced line manager

Skills

Essential

• Ability to listen to others and use critical questioning techniques to identify core issues to negotiate a path forward that meet the needs of all stakeholders
• Excellent communication skills and the ability to apply these to create technical documents (e.g. regulatory reports, SOPs) and to correspond with research staff at all levels in an appropriate format
• Experience of regulatory inspections, especially by the MHRA

Personal attributes

Essential

• Ability to work autonomously and manage own day-to-day workload, prioritising as needed
• Ability to work as an effective member of a multidisciplinary team and ensure quality related issues are identified and followed up in a timely manner.
• Ability to work flexibly with a positive approach to work, to meet the needs of the service.

Further information
The post will be based in the Research Management Hub within the R&D Department at Guy’s Hospital, Tower Wing. However, it is a requirement of employment that the post holder works at any of the KHP Partner NHS Trusts hospital sites or King’s College London campuses as required to effectively deliver the role and responsibilities.
As part of our commitment to a progressive working culture, King’s provides opportunities for hybrid working – a mix of on campus and home working: the amount of time that staff are required on site is determined by the needs of their role.
Appointment within discretionary spine points will be considered based upon experience.

Please refer the Job description for details