Quality Manager

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).

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

Closing date: 19 May 2024

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