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Summary

broad experience in cardiological device studies: project execution and support at site level, CRA, Project Management and people management experience.

Experiences

Current Experience

  • Sr. Manager Clinical Trial Operations THV Europe


    Since June 2013

Past Experience

  • Clinical Program Manager Europe

    December 2012 --- June 2013

  • Clinical Manager

    February 2011 --- November 2012
    leading group of 9 Clinical project leaders working on pre- and postmarket studies (cardiac rhythm management and atrial fibrillation) within the emeac region.

  • Clinical Project Leader

    October 2008 --- January 2011
    •managing postmarket studies in europe, middle east, africa and canada from initiation to close-out incl. scientific publication preparation •Training of internal sjm staff and external customers on study details and regulatory items to conduct studies at site

  • Clinical Research Associate (CRA)

    April 2007 --- September 2008
    • managing and monitoring of investigational sites in germany, austria and czech to conduct Clinical research in cardiac therapies and Vascular solutions • ensuring trials at site level are conducted, recorded and reported in accordance with the clinical investigational plan, SOP’s , quality standards and metrics, and applicable regulatory requirements

  • Field Clinical Monitor / Engineer

    June 2002 --- April 2007
    •implantation and Technical Support of Clinical icd's and pacemakers (including biventricular systems) for regulatory approval •product and study trainings for physicians and nurses according to Clinical investigational plans •monitoring of studies (inducing application of Ethics committee approvals for Medical Devices in investigational incl. FDA studies and postmarketing studies)

  • Perfusionist, Heart Surgery Department

    April 2000 --- June 2002
    • perfusions on adults and children (>500 cases) • neonatal perfusion • extra corporal membrane oxygenation • ventricular assist devices (debakey©, tci©, thoratec©)

Knowledge

LinkedIn Assessment :
Clinical researchMedical DevicesResearch Project ManagementISO 14155Clinical monitoringNew indicationProcess Managementpeople managementLine ManagementICH-GCPMPGHealth EconomicsCardiologyProject ManagementmanagementProcess ManagementClinical trialsClinical DevelopmentRegulatory affairsInterventional CardiologyBiomedical EngineeringCTMSPacemakersSurgeryPharmaceutical IndustryFDA

Education

  • Master's Degree in Clinical Research Management from Scientific University Lahr, Germany in 2014
  • Graduate Engineer (Dipl.-Ing.) in Biomedical/Medical Engineering from Fachhochschule Aachen in 2000
  • Paramedic (Rettungsassistent) in advanced medical emergencies and trauma care from DRK Rettungsdienstschule Muenster in 1996

Area / Region

Aachen, Germany

Others

Driving License
  • No

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