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Quality Manager

Employer
KINGS COLLEGE LONDON
Location
London (Central), London (Greater)
Salary
£62,696 to £71,857 per annum, including London Weighting Allowance
Closing date
17 Mar 2024

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Job Details

 

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.

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
  • 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 
  • 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
  • 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 

Essential Criteria

  1.  Comprehensive knowledge of clinical trial regulations, good clinical practice guidelines and other regulatory frameworks and their implication for health research 
  2. Proven extensive experience of working within a clinical research quality assurance role, either within academia, the NHS or the pharmaceutical industry
  3. Extensive Experience of clinical trial monitoring and/or audit. 
  4.  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.
  5. Comprehensive knowledge and understanding of standards and legislation that govern research in the NHS
  6. Educated to post graduate (Master’s degree) level in health/health related area or equivalent professional experience
  7. Significant Experience of supporting third party or internal audits and/or monitoring visits and developing audit/monitoring plans and CAPAs 
  8. Experience of managing risk based system

Desirable

  1. Quality Assurance/ Governance related professional qualifications
  2. Knowledge of the NHS RD agenda
  3. Experience of Policy/SOP development

Further Information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers review your application, please take a look at our ‘How we Recruit’ pages.

Interviews are due to be held on 27th March 2024.

This role does not meet the requirements of the Home Office and therefore we are not able to offer sponsorship for candidates who require the right to work in the UK.

Company

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

Company info
Mini-site
KINGS COLLEGE LONDON
Telephone
+(44)02078365454
Location
STRAND
LONDON
WC2R 2LS
United Kingdom

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