Mag. Tatiana Gordeichik

Medical Monitoring and DMC Meeting minutes preparation; medical advisory board set-up & activities overview; diverse administrative and clerical support of the department (presentations, trackers, control of adherence to safety reporting rules, SAE reporting, correspondence flow); organization of therapeutic area trainings

Regulatory submissions; coordination of teams (12 countries); Client meeting minutes; QC checks and review of study documentation; sites & vendors communication; Trial Master File & Investigator Site File QC checks, follow through and dispatch to the client; preparations & follow-up on internal/external audits and regulatory agencies inspection; Investigator Meetings preparation; sites Initiation, supervision and Close out including documentation flow and processing; trainings of Clinical Operations staff

Sites and vendors communication; regulatory submissions; preparation of agendas and minutes of meeting; clerical and administrative project support; audit preparation and follow-up; non-medical training of site staff; database and tracking systems maintenance; study documentation processing and filing; financial and contractual documentation processing; assistance with procurement of regulatory documents; collection and maintenance of TMF and ISF

supervision of exams; consultation of candidates; distribution of exam materials; collection and forwarding of written tests; documentation flow maintenance

communication with international clientele; interpreting activities (German-English-Russian-Spanish)

communication with international customers and scientists; databank maintenance; clerical and administrative support; main contact for clients/scientists from Belgium, Switzerland, the Netherlands, Spain, UK, Australia, USA and New Zealan

clerical and administrative assistance

customer service

Business Administration course, International Business Administration

English and German Linguistics; Psychology, Sociology, Philosophy, art history