Education:
Moscow State University, Suffolk University
Bragging Rights:
Expertise spans experience and knowledge of Clinical Systems, Data Management, BioStats and Programming as well as ClinOps Document Management, SDTM, ADaM, CDASH, TMF/eTMF standards and CFR part 11 and Annex 11 as it applies to data, eSubmissions, electronic records and systems validation. In the past I have implemented and worked with Clintrace, AERs, Argus and Image Solutions' ISI Writer when supporting safety and regulatory activities, with MediData Rave, InForm, Oracle Clinical, Nextrials EDC systems while leading Data Management activities, with Documentum, Open Text, TrialWorks, MasterControl and SharePoint when working with document management, collaboration and project management aspects of Clinical Operations and Quality.