Quality Manager

About us

The King’s Health Partners Clinical Trials Office is a collaboration between King’s College London, Guy’s & St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It was set up to provide a single interface for those wishing to conduct clinical trials within the partner organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.

About the role

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 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 is a full time post (35 Hours per week), and you will be offered an indefinite contract.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria 

• Educated to postgraduate (master’s degree) level in health/health related area or equivalent professional experience
• Comprehensive knowledge and understanding of standards and legislation that govern research in the NHS and academia
• Comprehensive knowledge of clinical trial regulations, good clinical practice guidelines and other regulatory frameworks and their implication for health research.
• Excellent communication skills and the ability to apply these to create technical documents (e.g. regulatory reports, CAPAs, SOPs) and to correspond with research staff at all levels in an appropriate format
• 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
• Experience supporting regulatory inspection, especially by the MHRA
• Experienced line manager with the ability to work flexibly with a positive approach to work, to meet the needs of the service
• 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

Desirable criteria

• Quality Assurance/ Governance related professional qualifications.
• Proven experience of working within a quality assurance role, either within academia, the NHS or the pharmaceutical industry
• Experience of managing risk-based systems
• Extensive experience of clinical trial monitoring and/or audit
• Experience leading a multidisciplinary team

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click “Apply”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

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