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eTMF Lead
eTMF Lead at Biomapas, overseeing Veeva Vault eTMF setup and quality control to keep clinical trial documentation inspection-ready.
UkraineeTMF Lead at Biomapas
Lead the setup, maintenance and ongoing quality oversight of TMF in electronic environment. Work hands-on with Veeva Vault eTMF, supporting eTMF setup, maintenance, document management and quality control.
Veeva Vault ETMFTMF Setup and CloseoutTMF MaintenanceQuality ControlDocument ManagementInspection ReadinessGCPICH Good Clinical Practice (E6 R3)
Managed PSI and Client TMF activities across up to 20 clinical trial projects simultaneously, ensuring documentation completeness, quality and compliance. Led and coordinated an international team of up to 9 employees across multiple countries.
TMF ManagementETMFDocument ManagementTeam LeadershipClient ManagementVendor ManagementAudit PreparationInspection ReadinessSOP DevelopmentTraining
Managed the Document Center team and day-to-day document management operations. Provided leadership and oversight of TMF and eTMF maintenance activities.
Team LeadershipDocument ManagementTMFETMFQuality OversightAudit SupportInspection ReadinessTrainingQSD
Managed electronic and paper TMF/PMF documentation. Performed document archiving and TMF review.
TMFPMFDocument archivingDocument ManagementScanningFilingAudit SupportTraining
Managed electronic and paper PMF documentation. Performed document archiving and TMF review.
PMFTMFDocument archivingDocument ManagementScanningFiling
Supported document scanning processes. Supported document archiving and electronic PMF maintenance.
Document ScanningDocument archivingPMFFax ProcessingDocument Management
Master's degree in International Economic Activity from 2002 to 2003.
Master's degree in International Economic Activity from 2002 to 2003.
Bachelor of Science in Management from 1997 to 2002.
Bachelor of Science in Management from 1997 to 2002.