Quality Manager

KINGS COLLEGE LONDON

vacanciesin.eu


2 Mar 2024
Job Information

Organisation/Company
KINGS COLLEGE LONDON
Research Field
Other
Researcher Profile
Recognised Researcher (R2)
Established Researcher (R3)
Country
United Kingdom
Application Deadline
17 Mar 2024 – 00:00 (UTC)
Type of Contract
Permanent
Job Status
Full-time
Is the job funded through the EU Research Framework Programme?
Not funded by an EU programme
Is the Job related to staff position within a Research Infrastructure?
No

Offer 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.

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

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

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

    Requirements
    Additional Information
    Work Location(s)

    Number of offers available
    1
    Company/Institute
    KINGS COLLEGE LONDON
    Country
    United Kingdom
    City
    London (Central)
    Geofield

    Where to apply

    Website
    https://www.timeshighereducation.com/unijobs/listing/366643/quality-manager/?Tr…

    Contact

    City
    London (Central)

    STATUS: EXPIRED

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