The post-holder will develop, implement and maintain a clinical trial and GCP audit and monitoring programme, improving the R&D Quality Management System (QMS) with a particular focus on studies that are sponsored/co-sponsored by GSTT. This will include risk-assessments at grant stage and supporting the R&D sponsorship team of risk management during the set-up process. Responsibilities will include incident and breach management, CAPA, the establishment of sponsor oversight mechanism for third-parties e.g. selected CTUs and vendors, report and SOP and guidance document writing. Along with in-depth technical knowledge about clinical trials, ICH-GCP and their regulations, the post-holder will have experience in trial monitoring and/or GCP auditing, change-management and be a skilled influencer who will collaborate with professionals at all levels including senior clinical investigators, KHP CTO, R&D clinical trials management platform, KCL RMID and RGO research delivery managers and staff and the wider R&D office. This is an exciting opportunity to promote and lead quality research culture across a complex organisation.