Quality Assurance Manager

• A higher degree in a relevant biomedical or associated subject or a graduate with extensive experience within clinical trials quality management.
• Must be able to demonstrate experience in quality management within a quality assured environment (e.g. GCP, GMP, GLP, ISO9000 etc.)
• Experience of developing and/or maintaining quality management systems and writing SOPs is essential.
• Experience of staff management.

Knowledge and Skills

• A working knowledge of applicable regulations and guidance documents pertinent to clinical trials (e.g. Medicines for Human Use (Clinical Trials) Regulations, UK Policy Frameowrk for Health and Social Care Research, GCP etc.) is essential for this post.
• Must be able to demonstrate a good understanding of clinical research and audit procedures.
• Highly developed interpersonal, negotiation, presentation, and communication (written and verbal) skills are essential.
• Excellent IT skills. Familiarity with Microsoft Office: including PowerPoint and utilisation of advanced features of Word is essential.Experience with Microsoft Access and/or Q-Pulse document management system would be an advantage.
• Excellent organisational skills.
• Able to work on own initiative and problem solve.
• Must demonstrate a critical and intelligent attention to detail with high standards of accuracy.
• Proven ability to work to strict deadlines.
• Must be able to work independently and as part of a team.
• Ability to travel nationally and internationally (on occasion) is essential.The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is currently seeking a Quality Assurance (QA) Manager.

This is an exciting opportunity to join one of the largest UK Clinical Research Collaboration (UKCRC) registered clinical trials units in the country. The CRCTU is based in the Institute of Cancer and Genomics, University of Birmingham and specialises in running cancer clinical trials. The Unit has an extensive portfolio of phase I, II and III clinical trials in adults and children in cancer and non-cancer disease sites. The Unit employs a multidisciplinary team of over 180 staff including statisticians, systematic reviewers, trial management staff, research nurses, monitors, programmers, administrators and IT staff. The CRCTU receives substantial core funding from Cancer Research UK and additional funding from other charities, government and pharmaceutical companies.

The Quality Assurance (QA) Manager plays a senior role in the CRCTU. They are responsible for developing, implementing and maintaining the QMS, establishing an internal and external risk based audit program, and managing a team of monitoring and quality management staff. They will play a key role in audits and inspections of the Unit. The QA Manager is expected to have a national profile as an expert in clinical trials quality systems.