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Summary

Self-driven and eager to constantly learn new things

Experiences

Current Experience

  • Associate Start Up Project Managerb
    Since January 2016

Past Experience

  • GSS Specialist 1
    March 2014 --- December 2015

    • Initial and Amendment Submissions to EC as well as contrats négociation in Belgium and The Netherlands 
    • Supporting in Start-up project management tasks 

  • Assoc. RSU Specialist - Translation Coordinator
    February 2011 --- March 2014
    *Coordination of translations; negotiations of prices and deadlines with translation agencies; adaptation to Belgium requirements, translation and review of patient documents and labels * Submission to EC and RA

  • Sales Associate
    February 2010 --- August 2010
    Representation of the company in order to get new clients

  • Senior Trainer
    February 2010 --- August 2010
    English and French Trainer at various companies

Personality

Self Assessment :
AdaptabilityAssertivenessAttention to detailCoordinationCritical thinkingEfficiencyEgoismInterest in knowledgeOptimismProactivityProblem solvingSelf-confidenceStriving

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryGCPCROICH-GCPClinical DevelopmentCTMSRegulatory affairsSOPClinical researchInformproactiveEye for DetailsCommunication SkillsTranslationProject CoordinationCustomer ServiceLeadershipLinguistics

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF)Act as the main line of communication between the sponsor and the investigatorAdvise on strategyCollaborate with project teamCommunicate with sponsorContract approvalCoordinate ethics committeeCoordinationCreate clinical project documents according to the protocolDevelop study metricsDirect co-workers to achieve resultEthics committee applicationEthics committee submissionsInitiate clinical trials Lead teamsManage Clinical Trial Management System (CTMS) project managementReferral lettersRegulatory submissionsSolve problemsUnderstand protocolsWork collaboratively with the other members of the clinical research team Work cross-functionally

Education

  • Master's degree in Translation International Relations from Institut Supérieur de Traducteurs et Interpretes, Uccle in 2009

Training and Certification

  • ICH-GCP in 2015 Certification

Languages

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

Work Preferences

  • Notice Period:
    7 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Clinical Project Leader Project Manager Clinical Study Manager Clinical Trial Manager
  • Work From Home:
    Yes, 2 to 4 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Bruxelles

Others

Driving License
  • Yes