"Quality Assurance Manager - CCTU"

About us

The Comprehensive Clinical Trials Unit is a specialist unit set up within the Institute of Clinical Trials and Methodology with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies.

The CCTU provides clinical, statistical and trial operations leadership and facilitates the delivery of high quality, regulatory compliant clinical trials of both investigational medicinal products (IMPs) (in compliance with the UK regulations governing the conduct of clinical trials of IMP) and other non-IMP trials and studies.

The CCTU is a registered CTU with the capability to centrally coordinate multi-centre clinical trials (i.e. having overall responsibility for the design, development, recruitment, data management and analysis of trials) with robust systems to ensure conduct and delivery of clinical trials to the highest quality standards.

About the role

An enthusiastic, committed and professional individual is sought for the role of Quality Assurance Manager, which is based in Holborn, London. The main purpose of this post is to ensure that staff at the CCTU conduct clinical trials in accordance with applicable guidelines and regulations. In particular the role holder is responsible for maintaining and overseeing Quality Management Systems at the CCTU, including the portfolio of central standard operating procedures (SOPs), providing/arranging staff training relating to the procedures and conducting a programme of internal audits. The position involves liaison with all staff at the CCTU and with a wide range of academic, managerial and administrative staff, including the Joint Research Office, the Institute of Clinical Trials and Methodology and other departments within UCL. Contact with regulatory bodies and research ethics committees regarding QA and auditing issues is also essential to the role.

Interviews will take place in person on 24th March.

If you have any queries regarding the vacancy or the application process, to arrange an informal discussion regarding the post please contact Felicia Ikeji at f.ikeji@ucl.ac.uk.

This is a permanent role, which is available immediately.

About you

The successful applicant must possess a postgraduate degree and/or equivalent experience in Clinical Trials, as well as a comprehensive understanding of UK Clinical Trials Regulations, ICH Good Clinical Practice, the European Directives on Clinical Trials and Good Clinical Practice and the Department of Health’s Research Governance Framework. Experience of working in a clinical trial regulatory environment is also required. Experience of staff supervision or line management would be required for this post as well as experience of establishing and maintaining quality management systems.