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Experiences

Past Experience

  • Sr. CRA Sierra Leone
    April 2015 --- September 2015

    FHI 360, SCRA for an Infectious Disease study in Sierra Leone (West Africa) sponsored by the US CDC (Center for Disease Control) monitoring and mid term site evaluation (4 of the 6 sites)

     Indication: Ebola Virus

  • Sr. CRA Germany
    September 2014 --- December 2014

    Nevro Corp., ICF and protocol writing support and translation for an Implantable neurostimulation device, Back-up CRA, Germany, Indication: Back pain management

  • Sr. CRA Germany
    June 2010 --- December 2014

    Boston Scientific International

    CRA for Medical Device study, Pacemaker / ICD Germany, indication: Cardiac Rhythm Management

  • Sr. CRA Germany
    September 2014 --- November 2014

    Nyxoah Ltd., CRF writing, worksheet design and ISF essential documents creation in preparation for CA and EC submission of an implantable active neurostimulation device, Germany & Belgium, Indication: Sleep Apnoea

  • Co-Auditor Austria
    June 2014 --- June 2014

    System Data Management Co-Audit at Assign group Innsbruck

    (CRO) conducted for CROMA GmbH

  • Clinical Research Associate (CRA) EU
    December 2011 --- December 2013

    Inspire medical systems

    Site manager for implantable active medical neurostimulation device study, Germany, Belgium, France, and The Netherlands, total 9 sites. indication: Sleep Apnoea

  • Sr. CRA Germany
    February 2012 --- August 2013

    Biosense Webster (J&J),

    CRA for Interventional Medical Device study, Germany, indication: Ablation treatment for AFib.

    Status: closed

  • Clinical Research Associate (CRA) Germany
    January 2009 --- December 2012

    Edwards Lifesciences GmbH, CRA for Medical Device Study, monitoring sites in Germany, Czech Republic, Finland, Sweden, Norway & The Netherlands, indication: Trans-catheter Aortic Valve replacement

  • Lead CRA Switzerland
    July 2010 --- December 2010

    Edwards Lifesciences LLC,

    CRA Leader for an International Medical Device Study (a.i.), eCRF review and lead in CRF design changes with the engineers of MediData in Boston, indication: Trans-catheter Heart Valves

  • Clinical Research Associate (CRA) Germany, EU
    June 2010 --- September 2010
    Guidant / Boston Scientific International, CRA for Study closeout visits in Europe and Germany. (Pacemaker / ICD) indication: Cardiac Rhythm Management

  • Clinical Study Manager Germany, Switzerland
    August 2009 --- March 2010

    Edwards Lifesciences LLC, European Study Manager for THV (Trans-catheter Heart Valve) study (a.i.)

  • Clinical Research Associate (CRA) Germany
    January 2009 --- November 2009
    Edwards Lifesciences GmbH, CRA for Medical Device Study, Germany, indication Mitral Valve Reconstruction Device

Personality

Self Assessment :
Analytical thinkingApproachabilityAssertivenessAttention to detailAuthenticityCommunicativeCoordinationCreative thinkingCritical thinkingEfficiencyFlexibilityInnovative thinkingInterest in knowledgeOptimismOrganizationKindnessProblem solvingResponsibilityResult OrientedSelf-confidenceSelf-disciplineStrategic thinking

Knowledge

Self Assessment :
Medical devices NegotiationAllergy and immunologyBiotechnologyBudget ManagementCAPACardiologyCardiovascular diseasesClinical operationsClinical monitoringClinical researchClinical trial managementClinical trialsContract negotiationCross-functional team leadershipCTMSDesigning case report formsDrug regulatory authoritiesEnglishEDC BiostatisticsEfficacy trials BiochemistryElectronic Data Capture (EDC) ElectronicsEthics submission and approval processGermanGCPGood Clinical Practice (GCP)HospitalsICH GCP guidelinesImmunologyInfectious diseasesInformed Consent ProcessInterventional RadiologyMarket accessManaging Clinical Trial SuppliesMarketing approvalMedical DevicesMedical ImagingMicrosoft OfficeMonitoring Study ProgressNeurological surgeryNuclear radiology Orthopedic surgeryOtorhinolaryngology (ear, nose & throat)FDAPatient Screening and RecruitmentPatient Follow Uppeople managementPhases of clinical development (phase I to IV)Principles and ethics of clinical researchProject ManagementProtocolQuality Assurance (QA)Quality of Life (QoL) outcomesRandomization and blindingRegulatory affairsRegulatory submissionsSerious Adverse Event (SAE)SOPSupervising CRAsTeam LeadershipUnderstanding of regulatory guidelines

Skills and Expertise

Self Assessment :
international management experienceInternational Clinical ReseachInternational CRMInternational CRAClinical site managementSite selection and start-upSite trainingSite problem solvingMulti lingualSeasoned professionalTechnical background and liason experienceFull skill set to support start-up companies

Training and Certification

  • Implantable Neuro stimulation device training for pain management in 2014 Training
  • Neuro stimulation device for sleep apnea in 2011 Training
  • ISO training on the implementation of the 4th novel EU Guidlines for Medical Product studies in Germany in 2010 Training
  • Cardiac rhythm management, Pacemaker, ICD, CRT in 2009 Training
  • THV replacement / system in 2009 Training
  • GCP in 2008 Training
  • ISO 14155 & Declaration of Helsinki in 2007 Training
  • FDA 510k requireents in 2006 Training
  • Personnel assessment and development in 2004 Training
  • CITI training for FDA in 2015 Certification
  • Ablation device training Biosense Webster in 2012 Certification
  • Marketing Nima A in 2002 Certification
  • Middle Management in 2000 Certification
  • Electronics engineering in 1981 Certification

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    40-60 Hours per week
  • International:
    Yes

Area / Region

Germany

Others

Driving License
  • Yes