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Summary

master`s degree in Pharmacy, > 10 yrs experience in Clinical research in pharma and CRO for ukraine & other markets; strong Project Management & Problem-solving skills.

Experiences

Current Experience

  • Clinical Project Manager (CPM)


    Since February 2016

Past Experience

  • Project Manager / SrCRA / Local expert for e-systems

    July 2012 --- January 2016
    Project Manager, srcra, local Expert for e-systems

  • Senior Clinical Research Associate (CRA)

    February 2008 --- June 2012

  • Clinical Research Associate (CRA)

    March 2005 --- January 2008

  • Pharmacist

    September 2004 --- February 2005

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCollaborationCoordinationCuriosityEfficiencyFlexibilityIndependenceProblem solving

Knowledge

Self Assessment :
R&DAdverse Events (AE)Cancer ResearchCardiologyCAPACancerCardiovascular diseasesClinical researchClinical trial audits and inspectionsClinical trialsCRFCROElectronic Data Capture (EDC) InflammationInformed Consent ProcessInternational Project ManagementManaging Clinical Trial SuppliesOperations ManagementOncology Clinical ResearchOutlookOutsourcingPhase IIPhase III
LinkedIn Assessment :
Clinical monitoringICH-GCPGCPClinical trial managementClinical researchClinical trialsCROoncologyClinical DevelopmentPharmaceuticalsNeurologyRegulatory submissionsPharmaceutical IndustryTherapeutic AreasPharmacovigilanceEDCCTMSClinical Research AssociatesRegulatory affairsInfectious diseasesPsychiatryLife SciencesBiotechnologyClinical Data ManagementDrug DevelopmentGood Clinical Practice (GCP)Data AnalysisProject Oversight

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Build and manage the Trial Master File (TMF) Interact with physiciansAdverse event reportingApprove drug supply Approve consent documentsApprove monitoring reportsApprove Label Master SheetApprove patient informationApprove queriesArchive documentationArchive study documentsAssess quality process issuesAssess site feasibilitybudgeting of R&D activitiesConduct close-out visitsConduct maintenance visitsConduct site initiationDevelop ICH/GCP compliant processesDesign trial master file (TMF)Ensure good clinical practice (GCP)Interact with CROsInteract with KOLInteract with physiciansManage budgetsManage clinical suppliesManage risksManage trial master file (TMF)Monitoring enrolmentproject managementProvide benefit risk assessmentR&DReport serious adverse events (SAE)Respond to audit findingsReview reportsScreen patientsTrain off site staffTrain on site staffTrain Staff

Education

  • Master in Pharmacy from National Medical University in 2003

Training and Certification

  • Applied Project Management Certification in 2017 Certification
  • IELTS exam of British Council in 2016 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Russian
Native
Ukrainian
Native
English
Professional Proficiency
German
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    associate Clinical Project Manager Clinical Operations Manager Clinical Project Leader Quality Assurance (QA) Manager
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    Austria Canada Czechia Germany Italy Norway Poland Sweden Ukraine USA
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Ukraine

Others

Driving License
  • No

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