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Summary

Quality Assurance through innovative approach in Clinical Development 

Experiences

Current Experience

  • Inspection readiness specialist


    Since July 2015

Past Experience

  • Clinical trial coordinator

    January 2013 --- June 2015

  • Laboratory of clinical research and development

    March 2007 --- July 2008

Personality

Self Assessment :
AdaptabilityAttention to detailCharmCommunicativeCreative thinkingCritical thinkingCuriosityEfficiencyInnovative thinkingInterest in knowledgeOptimismOrganizationProblem solvingProactivityResponsibilitySelf-disciplineStrategic thinkingResult Oriented

Knowledge

LinkedIn Assessment :
Microsotf SharePointICH-GCPKlinische StudienKlinische ForschungClinical trialsMicrosoft OfficeClinical researchClinical DevelopmentRegulatory submissionsCTMSCommunicationGMPProject ManagementOC RDCVendor Management SkillsICH guidelinesFile ArchivingSales

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Analyze data Create SOPs Interpret data Report data Technology researchAdjust processes and methodsApprove consent documentsApprove monitoring reportsArchive documentationBuild trial master file (TMF)Coach and provide guidance to clinical staff.Communicate effectively on different company levelsDesign IT solutionsDevelop ICH/GCP compliant processesDevelop study metricsExecute internal/external quality assurance assessmentsImplement Key Performance Indicators (KPI's)Interact with CROsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage multiple projectsProvide trainingQuality control processReport non-compliance incidentsSolve problems

Education

  • Engineer's degree in Pharmaceutical production from State College of Technology and Administration in 0000

Languages

BrightOwl Assessment:
Self Assessment:
German
Full Proficiency
English
Full Proficiency
Russian
Native

Work Preferences

  • Notice Period:
    5 weeks
  • Positions I am interested in:
    Quality Assurance (QA) Manager
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Vienna, Austria

Others

Driving License
  • No

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