Operational team leader of Trial Operations team (team of CTAs with different specializations - contracts, payments, archivation, TMF, etc.) supporting CRAs and project managers. Responsible for CTA workload, management, training, set up of internal processes, etc.

Employee of NEOX, s.r.o. currently working for Novartis, s.r.o. as a Trial Operations Country Lead.

Main activities and responsibilities Trial and site administrative support, document management and quality assurance, regulatory ans site start up activities, training and quality control of newcoming CTCs, clinical trial database management, performing all types of co-monitoring visits (initiation, ongoing, close-out)Pharmacovigilance / safety reporting specialist - large overview, management and responsibility for safety reporting in all clinical trials, got through PV audit with no observationsSkills and knowledge with merger of pharmaceutical companies ( two times) - operational procedures, database, system changes