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Summary

global trial manager with huge experience in national and international pivotal Clinical trials, recognized Leadership and people management, strong kol’s networking and expertise in onco-Hematology and with clear understanding of patients’ needs

Experiences

Current Experience

  • Global Clinical Project Manager (GCPM, GTM)


    Since April 2011

    • worldwide management of international Clinical studies (Phase I, ii & iii) • writing of trial science)" rel="nofollow">Protocol (from template to final version) for worldwide submission to Health authorities & Ethics committees (including FDA, EMA…) and co-signatory with coordinating Investigatororganization, preparation and presentation of international Investigator meetings and CRA trainings in partnership with the medical team in several countries across the world including europe, usa, asia. • set up & leading of steering committee and data monitoring committee • trial budget management • virtual Clinical team management involving several vendors and local pm & cras • managing cultural differences in daily basis

    • Worldwide management of international clinical studies (Phase I, II & III) • Writing of trial protocol (from template to final version) for worldwide submission to Health Authorities & Ethics Committees (including FDA, EMA…) and co-signatory with Coordinating Investigator • Organization, preparation and presentation of International Investigator Meetings and CRA trainings in partnership with the Medical Team in several countries across the world including Europe, USA, Asia. • Set up & leading of Steering Committee and Data Monitoring Committee • Trial budget management • Virtual clinical team management involving several vendors and local PM & CRAs • Managing cultural differences in daily basis

Past Experience

  • Global Clinical Project Manager (GCPM, GTM)

    March 2007 --- March 2011
    expertise in hiv & hepatitis c

  • CRA- Start up team Leader - CRA Manager

    January 2002 --- March 2007

  • Nurse in hematology - Study nurse

    February 1992 --- December 2001

Personality

Self Assessment :
AssertivenessEfficiencyIndependenceOptimismOrganizationProblem solvingResiliencyResult OrientedStrategic thinkingTrustSociability

Knowledge

LinkedIn Assessment :
ELISAInfectious diseasesHematologyAMLoncologyLife SciencesBuilding Strong Referral Networksstrong presentation skillsTime ManagementHelicopter ViewSocial Team PlayerClinical researchICH-GCPClinical trialsGCPPharmaceutical IndustryClinical DevelopmentCTMSClinical monitoringSOPmolecular biologyBiotechnologyEDCVirologyCROVaccinesImmunology

Education

  • Master en sciences medico-sociales et hospitalieres in Faculte de medecine from Université catholique de Louvain in 1994
  • Baccalauréat in from Institut superieur de nursing in 1991

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Full Proficiency

Work Preferences

  • Notice Period:
    10 weeks
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

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