Aniko Gertner

Background

About Aniko Gertner

I am currently employed as a Compliance, Process, Training and Systems (CPTS) Advisor at Country Clinical Operation (CCO)-Roche UK. I am keen to work for a company that will utilise an enthusiastic, self-motivated individual, with a number of transferable skills to successfully and efficiently manage their Training and Quality Management System and Regulatory Processes. My broad clinical trials experience means that I have worked on all stages of clinical trials, and have built a strong understanding of how trials are developed and run. I have had the opportunity to play a major role in preparing key study documents, for REC and R&D submissions,(including the reviewing of clinical trial protocols), as well as for the running of clinical trials (CRFs, pharmacy and laboratory manuals, monitoring plans). Knowledge of regulations for pharmacovigilance and risk management. I have the ability to learn quickly and effectively, and am therefore keen to put myself forward in order to develop new skills and experiences.I believe that my career path so far has resulted in my having developed a strong CRO and pharmaceutical background in quality management. My broad clinical trials experience means that I have worked on all stages of clinical trials and have built a strong understanding of how trials and their Quality Management System (QMS) are developed and run. I have experience in ensuring all operational and quality processes are in compliance with regulations, and have been responsible for ensuring timely internal and external quality checks, following up audits and issuing CAPA's During my time as a Clinical Trials Co-ordinator in Haemato-oncology, aside from setting up and managing my own studies I was also responsible for setting up other trial sites. This entailed IRAS submissions, setting up Trial Master Files, co-ordinating monitoring visits, overseeing recruitment progress and ensuring milestones were met. I participated in feasibility meetings gaining an insight into how investigator sites view potential trials with regards to resources and therapy areas. Throughout my career, I have been able to build strong working relationships with staff at all levels, often working as part of a multidisciplinary team.Through prioritising and careful coordination, I have become increasingly efficient at time management, which ensures I am able to fulfil my tasks. The strong values of patient focus, ownership, results, openness and integrity are those that I hold true to myself and those that I work with