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Summary

i have > 16 years of experience in Clinical research.

  • start-up, monitoring and management of multicenter Clinical trials accross europe.
  • Phase I-iv - Expert in the national law (ie wmo) and regulations with respect to Clinical Trial submissions (ie ccmo guidelines).
  • performing all submissions to Ethics committees and competent authorities in nl
  • managing the clinical team (cras and assistants) and maintain sponsor contact -developing monitoring tools, monitoring plan
  • preparation and follow up of audits -performing qa checks -perform co-visits on site -Training site staff (study specific and ich-gcp)
  • co-Training for ich-gcp course
  • Coaching/mentoring CRA's

Therapeutic Areas with most expertise:

extended knowledge of Clinical Trial submissions in the netherlands, belgium and germany for Pharmaceutical and device Applications. international experience in monitoring Clinical trials in the netherlands, united kingdom, france, germany, sweden, spain, italy and austria. bachelor's degree in dutch law, extensive networker

Experiences

Current Experience

  • Senior Clinical Research Associate/Consultant


    Since October 2014
    responsible for Clinical studies in the netherlands and belgium Responsible for clinical studies in the Netherlands and Belgium

  • Senior Clinical Research Associate/Consultant


    Since September 2014
    management of a Phase I/ii trial in ovarian Cancer in belgium management of a phase I/II trial in ovarian cancer in Belgium

  • Managing Director


    Since June 2009
    staffing solutions for the bio-Pharmaceutical and Health Care industry Staffing solutions for the bio-pharmaceutical and health care industry

Past Experience

Knowledge

LinkedIn Assessment :
HematologyClinical trialsoncologyCROClinical monitoringClinicalPhase ICancerClinical researchClinical trial managementGCPEDCCardiologyPharmacovigilanceICH-GCPInfectious diseasesMedical DevicesLife SciencesRegulatory affairsTherapeutic AreasSOPBiotechnologyImmunologyPharmaceuticalsClinical DevelopmentUrologyRegulatory submissionsCTMSPharmaceutical IndustryClinical operationsNeurologyPharmaceuticsBiopharmaceuticalsMedical writingMedicineProtocolDiabetesDrug DevelopmentVaccinesFDADermatologyRegulatory RequirementsHealth EconomicsClinical Research AssociatesClinical Data ManagementHealthcareCellmanagementpharmacologyHypertension

Education

  • Bachelor in Dutch Law from Leiden University in 2009
  • M.Sc. in Bio-Pharmaceutical Sciences from Leiden University in 1997
  • High school (VWO) in VWO Degree from Veurs College Leidschendam in 1991
  • Primary School in - from Biezenhof in 1984

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
Afrikaans
Elementary Proficiency
German
Professional Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    7 weeks
  • Positions I am interested in:
    Global Trial Manager Clinical Trial consultant Clinical Research Associate (CRA) Clinical Project Leader Clinical Project Manager (CPM)
  • Locations I am interested in:
    Augsburg, Germany Munich, Germany
  • Work From Home:
    Yes, 3 to 0 days per week
  • Work Regime:
    BrightOwl freelancer :    up to 20 hours per week (more negotiable) Hours per week
  • International:
    Yes

Area / Region

Munich, Germany

Others

Driving License
  • Yes

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