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Summary

Management of projects in clinical trials ensuring countries performance within Eastern Europe, Middle East, Africa, Asia Pacific regions.

Experiences

Current Experience

  • Regional Clinical Project Manager, Associate Director
    Since September 2015
    Management of projects in clinical trials ensuring countries performance within European Union, Eastern Europe, Middle East, Africa regions.

  • Regional Clinical Project Manager, Associate Director
    Since July 2014
    Management of projects in clinical trials ensuring countries performance within Eastern Europe, Middle East, Africa, Asia Pacific regions.

Past Experience

  • Clinical Project Manager (CPM)
    November 2009 --- June 2014
    Managing in-house and Clinical Research Organizations (CROs) servicing trials within country from pre-study until close-out activities meeting timelines, budget and enrollment commitments; SOPs and personal projects developing; Serving as subject matter expert dedicated areas of clinical trials execution; In-house and CRO staff training and coaching; s management, Six Sigma principles implementation.

  • Senior Clinical Research Associate (CRA)
    July 2008 --- November 2009
    Projects oversee and coordination; Primiry point of contact and query resolution in respect of appropriate projects. Standard CRA’s responsibilities described below.

  • Clinical Research Associate (CRA)
    September 2006 --- July 2008
    Feasibilities; Delivery of GCP, IMP management, laboratory samples shipment, study procedures and EDC trainings to site staff; Participation and organization of Investigator Meetings, Submissions to Regulatory Body and Ethics Committee; Site Pre-Study, Initiation, Monitoring, Closure visits; Query and Issue resolutions; Drug accountability and storage conditions control; SAE Management; Preparation and participation in Audits

  • Customer Manager
    January 2003 --- July 2003
    Customers information support, meeting with customers, review of system features and tips, presentation of products, concluding agreements.

Knowledge

LinkedIn Assessment :
CROGCPSOPClinical trialsEDCClinical researchR&DTeam LeadershipSOP developmentCTMSProject ManagementCoaching StaffSix SigmaInnovationForecastingManaging Project BudgetsSAP ImplementationMS ProjectQuality ControlFlexibilityCross-functional CollaborationsMicrosoft ProjectSOPClinical DevelopmentClinical monitoringICH-GCPoncologyPharmaceutical IndustryPharmacovigilanceRegulatory submissionsTherapeutic AreasBiotechnology

Education

  • Residency in Pediatric Surgery from Saratov State Medical University, Chair of Pediatric Surgery in 2006
  • Highest medical in Pediatrics from Saratov State Medical University in 2004

Area / Region

Moscow, Russia

Others

Driving License
  • No