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Experiences

Current Experience

  • CTC Unit Lead
    Since September 2011
    Leadership, Recruiting, Capacity Planning, Audit and Inspection Preparation, Identification of Non-Compliance, Member of Quality Improvement Program, Quality Control, Trainer

Past Experience

  • Global Business Project Lead
    August 2015 --- May 2016

    limited assignment

  • Senior Clinical Trial Coordinator
    September 2010 --- August 2011
    Training of new Colleagues, Project Lead for several internal Projects

  • Clinical trial coordinator
    April 2010 --- September 2010
    co-monitoring, full responsibility of study documentation, quality control

  • Clinical Trial Assistant (CTA)
    July 2008 --- April 2010
    support in various parts to the project management; Labelling, Translations, Key User for various DBs,

  • Assistant Event and Projectmanagement
    February 2007 --- March 2008
    project and resource responsibility, support to CEO

Personality

Self Assessment :
AdaptabilityAttention to detailAuthenticityCollaborationCoordinationCuriosityDiligenceEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOptimismOrganizationPerspectiveProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineStrategic thinkingTrustStrivingWillingness to compromise

Knowledge

Self Assessment :
Phase I21 CFR Part 11AuditingBudget ManagementBudgetingBusiness DevelopmentBusiness IntelligenceBusiness ProcessBusiness Process ImprovementBusiness ProcessesCAPAChange ManagementClinical DevelopmentClinical operationsClinical trial audits and inspectionsClinical Trial Management System (CTMS)Clinical trialsCommunication SkillsComplianceCompliance with regulationsCross-functional team leadershipEnglishEvent ManagementGermanGood Clinical Practice (GCP)Health EconomicsHealthcare ManagementICH guidelinesHuman ResourcesInformation Management SystemsInternational Project ManagementIVRSIt skillsKnowledge of the drug development processLeadershipmanagementMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMS ProjectNutritionOracle ClinicalOutlookpeople managementPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PhotoshopPowerPointPresentation SkillsPrinciples and ethics of clinical researchProject CoordinationProject ManagementPublic HealthQuality ManagementRecruitingSocial SkillsSoftware DocumentationStandard Operating Procedure (SOP)Team BuildingTeam LeadershipTeam ManagementTeamworkTime ManagementTrainingUnderstanding of regulatory guidelines
LinkedIn Assessment :
Clinical trialsPharmaindustriePharmaceutical IndustryGCPCTMSDiabetesKlinische StudienKlinische EntwicklungGute klinische PraxisoncologyCROPulmonologyAudit and Inspection ExperienceWing Tai ÜbungsleiterLeadershipRecruitingMitarbeiterführung und EntwicklungProjektmanagementKlinische ÜberwachungClinical researchArzneimittelzulassungKlinische ForschungICH-GCPOnkologiePharmakovigilanz

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Control data Use content management systems Write papersAdminister, maintain and co-ordinate the logistical aspects of clinical trialsApprove Label Master SheetArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess business and scientific ethicsAssess quality process issuesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist with site trainingAttend at steering committee meetingsAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyAttend steering committeeBuild trial master file (TMF)CoachCoach staffCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with project teamCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationConduct literature searchescontrol different protocol versions and other essential documentsCoordinate projectsCreate clinical documentsCreate clinical project documents according to the protocolCoordinationCreate standard operating procedure (SOP)Create study documentsCreates a collaborative team environmentDesign tracking systemDesign trial master file (TMF)Determine needsDevelop ICH/GCP compliant processesDevelop study metricsDevelop training materialsDirect co-workersDirect co-workers to achieve resultDistribute study documentsDistribute trial suppliesDocument data collection systemDocument data reporting systemsDocument employees training requirementsEnsure good clinical practice (GCP)Follow up projectsFollow up training programsFollow-up of external auditsFollow-up of quality assurance activitiesFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesGuide staffIdentify growth / improvement potentialInteract with computer specialistsLead teamsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage complexityManage multiple projectsManage projects resourcesManage trial master file (TMF)managing a small teamPeople managementproject managementProvide study site fileProvide trainingRegulatory documentationRespond to audit findingsRetrieve study documentsStudy-related documentsUpdate Clinical Trials Management System (CTMS) Work collaboratively with the other members of the clinical research team Work cross-functionallyWork under specific instructionsWork with coordination and data management teams

Education

  • Master of Business Administration (MBA) in Business Administration and Management, General from WWEDU GmbH in 2008
  • Mag. (FH) in Health Management from FH Joanneum in 2006
  • Study abroad in Health and Social Services from New Mexico State University in 2006

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    Yes, 1 to 2 days per week
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    Yes

Area / Region

Austria

Others

Driving License
  • Yes