Yulia Bouras

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials; Prepares and submits Regulatory authorities Applications; Organization of site initiation documentation preparation, review and finalization of essential documents required for site initiation; Prepares ongoing submissions, required by RA, includes safety notifications as required by local rules; Follow up with RA for approvals / decisions obtaining.

Business unit documentation manage in compliance and statutory manner, including contacts maintenance; implementation compliance trainings for marketing representatives; budget tracking and reporting with some analysis and essential accruals basis accounting; participation in scientific event projects; administrative support of HBU

Head of representative office supporting in scope of coordination and providing with daily office purchasing; settlements; representative office expenses monitoring and reporting; medical product registrations organization and logistics inquires