We would like to appoint a Quality Assurance Manager to be responsible for the design, implementation, maintenance and ongoing improvement of the quality assurance systems of ICR Clinical Trials. The post holder will report to the ICR-CTSU Assistant Operations Director and will provide QA leadership to the joint ICR-CTSU/DDU IIT Quality Assurance Review Team (a multidisciplinary team of trial managers, statisticians, data managers, IT specialists and research administrators with responsibility for on-going review of the quality management system).
The post holder will plan, coordinate and conduct audits of clinical trial documentation and procedures and be responsible for ensuring procedures are fit for purpose and commensurate with level of risk. The post holder will provide quality assurance advice and support to colleagues within ICR-CTSU and DDU IIT and represent ICR-CTSU at relevant meetings within the wider ICR and Royal Marsden (RM) institutions and nationally, as required.
ICR-CTSU is in the process of implementing cloud-based e-trial solutions, including eTMF, to support their trials portfolios. The post-holder will have a key role in ensuring quality processes for implementation and on-going use.
Key Requirements
The successful candidate will have expert knowledge of quality systems in clinical research and a proven track record in the design, conduct and reporting of audits and the development and management of an annual audit program. Experience of developing Standard Operating Procedures and management of a Quality Management System is also essential. Candidates will have working knowledge of the Medicines for Human Use (Clinical Trials Regulations) 2004, Data Protection Act (1998), GCP and Research Governance. Experience and working knowledge of pharmacovigilance reporting is preferable. Candidates must demonstrate effective verbal and written communication and have excellent organisational skills.
Department/Directorate Information
The ICR's Clinical Trials and Statistics Unit (ICR-CTSU) is seeking a Quality Assurance Manager to join their team at ICR’s Sutton site in Surrey. ICR-CTSU runs a diverse portfolio of national and international phase III multicentre randomised controlled trials, and phase II trials of targeted treatments with a focus on breast, urological and head and neck cancer treatments. The post-holder will also work with the ICR’s Drug Development Unit (DDU) to align Quality Assurance activities across ICR sponsored clinical trials. The DDU specialises in first-in-human trials and provides a pathway from pre clinical drug discovery through to proof of principle phase I trials and tumour specific evaluation of novel agents .
Informal enquiries can be made by emailing ctsu@icr.ac.uk.