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Summary

specialties: - experienced in: Research project/study set up (Project Management), (electronic) data gathering, data reviewing and analysing, writing reports and scientific papers. Clinical Development studies (efficacy and safety, Lab and field) for Animal Health products (both pharma as Vaccines). specific interests are parasitology, auquaculture and Electronic Data Capture. -i am an active and communicative Coordinator with a good sense for initiative. i feel and work the best when i, together with others, can organise and create events and new projects. i’m a positivist and optimist and i use these characteristics to motivate others. - critical, focused on the goal, flexible and strong in Problem Solving. - free time: scouting and youth movement: i have experience in organizing events (for the local youth: the scouts, among others), supporting young leaders, Member of national board of scouts and guides flandres (an organisation with 75 000 Volunteer members and about 70 paid staff, 8 camp houses/camp places and 6 scout shops)

Experiences

Current Experience

  • Veterinary Clinical Manager


    Since December 2013
    coordinate and manage all study activities, including start up, Investigator Training, conduct, site monitoring and close out. preparing study protocols, data capture forms, test article Documentation and study reports. maintaining study files in accordance with sops and regulatory requirements. coordinating Data Management processes including data capture, entry, review, tracking and Verification. serve as the principal Communication link between sponsor and study site. provide Coaching and support to departmental colleagues. eu Electronic Data Capture (edc) business lead & Coordinator. Coordinate and manage all study activities, including start up, investigator training, conduct, site monitoring and close out. Preparing study protocols, data capture forms, test article documentation and study reports. Maintaining study files in accordance with SOPs and regulatory requirements. Coordinating data management processes including data capture, entry, review, tracking and verification. Serve as the principal communication link between sponsor and study site. Provide coaching and support to departmental colleagues. EU Electronic Data Capture (EDC) Business Lead & Coordinator.

Past Experience

  • Veterinary Clinical Research Sr. Associate

    November 2010 --- December 2013

    coordinate all study activities, including start up, Investigator Training, conduct, site monitoring and close out: preparing study protocols, data capture forms, test article Documentation and study reports. maintaining study files in accordance with sops and regulatory requirements. coordinating Data Management processes including data capture, entry, review, tracking and Verification. serve as the principal Communication link between sponsor and study site. provide Coaching and support to departmental colleagues. eu Clinical team representative in global electronic datacapture systems team.

  • Clinical data reviewer/manager

    April 2010 --- October 2010
    eCRF Validation (phase forward (inform)), data reviewing/handling, ich-gcp (edit checks, listings), query handling, (s)ae coding and reconciliation, coding, ...

  • Phd Medical Sciences

    December 2005 --- March 2010
    experimental Research on the function, anatomy and Physiology of the lower urinary tract and on the use of electrical stimulation. the use of intravesical electrostimulation for diagnosis and Treatment of the lower urinary tract was studied. the focus was on the mechanisms of action and the use of different waveforms.a strong background in Physiology and Neurology, especially of the urinary tract. taking care of daily management of the Lab.

  • Research Assistant

    August 2004 --- September 2004
    involved in reseach which tried to the determine if there is any relationship between the biomasse of cestodes (bothriocephalus scorpii) and the size (length) of a fish (hemitripterus americanus). teachers assistant on a marine ecosystem field course.

Personality

Self Assessment :
Interest in knowledgeOptimismKindnessFlexibilityEfficiencyDependabilityCuriosityCritical thinkingCollaborationSociabilityProblem solvingCoordinationOrganization

Knowledge

Self Assessment :
Animal models R&D Scientific writingAnimal trialBiological Drug DevelopmentBiopharmaceuticalsClinical DevelopmentClinical monitoringClinical researchClinical Study DesignClinical study reportsClinical trialsData cleaningCTMSDesigning case report formsDrug development processEarly development stageElectronic Data Capture (EDC) EMAEnglishGCPIn VivoKnowledge of the drug development processMicrosoft OfficePhase IIIPhase IVPhases of clinical development (phase I to IV)Principles and ethics of clinical researchProblem-solving methods and troubleshootingRegulatory RequirementsSOPUrologyWriting Study Procedures and SOPs
LinkedIn Assessment :
SOPData CollectionData ManagementClinical researchICH-GCPElectronic Data Capture (EDC) AquacultureRegulatory submissionsRegulatory affairsRegulatory RequirementsGCPValidationScoutingCoachingVolunteer ManagementVolunteer TrainingNon-profit Board DevelopmentEvents OrganisationInfectious diseases

Skills and Expertise

Self Assessment :
Analyze data Build and manage the Trial Master File (TMF) Create SOPs Control data Design case record forms Develop clinical trial protocols Develop protocols Interpret data Report data Write papersAdverse event reportingCoach clinical staffCollaborate with project teamCommunicate with investigatorConduct monitor visitsCoordinate with the ethics commiteecoordinating research projectsData validationDesign clinical trialDesign efficiency studyDevelop clinical trial protocolsDevelop ICH/GCP compliant processesInteract with CROsManage study budgetManage study supplyManage Clinical Trial Management System (CTMS) Monitor clinical trials NegotiationPrepare final reportPresent clinical resultsProvide trainingResolves queriesReview clinical study reportsReview study protocolsSet up a clinical study

Education

  • PhD in Medical Sciences, NeuroUrology from Universiteit Antwerpen in 2010
  • Proefdierkunde voor Proefleiders (Felasa niveau C) in Proefdierkunde (laboratory animal sciences) from Universiteit Antwerpen in 2008
  • Distinction in Master of Science, Advanced studies in Marine and Lacustrine Sciences from Universiteit Gent in 2005
  • Distinction in Master, Biology, Zoology from Universiteit Gent in 2004
  • High School degree in Mathematics and Sciences from Broederschool OLV Onbevlekt Ontvangen, Sint-Niklaas in 2000

Training and Certification

  • Felasa C in 2008 Certification
  • First Aid in 0000 Certification

Languages

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

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Belgium/Slovenia

Others

Driving License
  • Yes

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