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Summary

Experienced project manager in multinational environment. Setting up clinical studies with multifunctional teams. Protocol writing. Budget and resource planning and control. Supervision of multifunctional teams. Data Analysis in cooperation with statistician. Reporting of final data. Safety reporting. Trial registration. Publications. Writing of study procedures, document control, external and internal audit experience.

Familiar with CTMS, PDM, PPMS, Medidata RAVE

Languages: German, English, French, Spanish

Experiences

Past Experience

  • Product Manager Munich, Germany
    February 1989 --- December 1997

    Product approvals according to MEDGV

    Translation of device documention

    Training of internal personnel

    Physician Training

    Congress Planning

    Technical Support/Problem Solving

    Advertisement Planning

    Supporting clinical trials - Document translation and sumission to EC and competent authorities - Training of investigators - Contracting -  field clinical support - attending monitoring visits - abstract writing - attending congresses

Personality

Self Assessment :
AdaptabilitySociabilityStrategic thinkingSelf-disciplineProblem solvingProactivityOrganizationInterest in knowledgeIndependenceFlexibilityDiligenceCuriosityCritical thinkingCoordinationCollaborationAttention to detailAssertivenessAnalytical thinkingWillingness to compromise

Knowledge

Self Assessment :
Medical devicesCardiologyClinical Data Management (CDM)Clinical monitoringClinical researchClinical Study DesignClinical study reportsClinical operationsClinical trial budgeting Scientific writingClinical trial audits and inspectionsClinical trial managementCross-functional team leadershipData cleaningData AnalysisCTMSDesigning case report formsElectronic Data Capture (EDC) FDAGCPICH GCP guidelinesMicrosoft ExcelMicrosoft OfficeMonitoring Study ProgressPatient Follow UpPatient Screening and RecruitmentPowerPointPrinciples and ethics of clinical researchProject ManagementRandomization and blindingRandomization SystemsRegulatory RequirementsSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Safety trialsSerious Adverse Event (SAE)SOPStudy outcomes and outcome measuresTeam LeadershipInformed Consent DocumentsWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Analyze data Build and manage the Trial Master File (TMF) Create SOPs Control data Design case record forms Develop clinical trial protocols Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Write papersAdverse event reportingApprove consent documentsApprove patient informationArchive study documentsAssess adverse reactionsAssess site feasibilityAttend investigator meetingAttend steering committeeBuild trial master file (TMF)Calculate trial timelinesClinical data collection

Education

  • Bachelor of Science in Biomedical Engheneering from Fachhochschule Giessen in 1988

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency
French
Professional Proficiency
Spanish
Professional Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    Permanent position :    80% FTE
    BrightOwl freelancer :    32 Hours per week
    BrightOwl employee :    80% FTE
  • International:
    Yes

Area / Region

Rixensart, Belgium

Others

Driving License
  • Yes