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Experiences

Current Experience

  • Clinical Quality Associate
    Since April 2013
    (Medical devices – Clinical trials/studies in cardiac and vascular care) - Coordinates the appropriate assignment of training items and curricula for newly released or revised procedures which support functional roles. Maintains/update job-specific Training plans. - Owns and ensures Abbott Training Management System is maintained. Provides applicable training metrics and communicates non-compliance to management. - Assists with the implementation of new training technologies such as e-Learning, computer based training (CBT). - Assists with continuous improvement training process.

Past Experience

  • Senior Data Processing Technician
    September 2002 --- January 2011
    (Pharmaceutical– medical – clinical trials/studies sector, Clinical Research Organization) - Supports the training team as a Subject Matter Expert and/or Assessment Reviewer - Assists with the testing of databases and data entry screens and performs edit checks - Draft and/or assist with the preparation of study-related guidelines and templates - Performs quality control activities (QC checks) as defined - Maintains and manages data entry into designated clinical tracking systems in accordance with project requirements - Creates and maintains designated study tracking systems in accordance with study requirements - Creates, maintains and updates study tracking tools/lists - Performs tracking, scanning, indexing and entry of CRF data following study specific guidelines into the databases - Filing of clinical and departmental documents

  • Receptionist trilingual
    August 2001 --- August 2001
    Short time mission (Optic ocular sector) - Responsible for the cover of all incoming telephone - Ensure visitors support - Support to the administration and the interface with different services - Receive visit request by phone, receive and redistribute all the mails.

  • Receptionist quadrilingual
    January 2001 --- July 2001
    (Audit, finance services, taxation, legal, consultancy sector) - Responsible for the cover of all incoming telephone (and fax) communications - Receiving visitors and visit request by phone - Support to the administration and the interface with different services - Receive and redistribute all of the registered letters or express - Manage meeting rooms

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCollaborationAuthenticityCoordinationEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOrientationProblem solvingOrganizationProactivityResponsibilityResult OrientedSelf-confidenceSelf-disciplineService orientedSociabilityTrustCommunicativeCompetitiveness

Knowledge

Self Assessment :
Diabetes21 CFR Part 11Adverse Events (AE)AuditingCancerClinical Data ManagementClinical DevelopmentClinical researchClinical trial managementClinical Trial Management System (CTMS)ComplianceCRFCROCTMSData entryData ManagementDatabasesDesign and tracking systemsDatabase design and maintenanceDrug Safety and PharmacovigilanceElectronic Data Capture (EDC) Electrocardiogram (ECG)EnglishEndocrinology and metabolismFDAGood Clinical Practice (GCP)ICH guidelinesInfectious diseasesInformed Consent DocumentsMedical DevicesMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMultilingualNeurologyoncologyOracle ClinicalOrthopedicOutlookOutsourcingeCRFEndocrinologyGood Manufacturing Practice (GMP)Pharmaceutical DevelopmentPharmaceutical ResearchPharmacovigilancePhase IIIPhase IVPhases of clinical development (phase I to IV)Problem-solving methods and troubleshootingProcess improvementProduct developmentProtocolQA complianceQuality Control (QC)Quality AuditingQuality Assurance (QA)Quality SystemsSchizophreniaSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Study protocolsTeam LeadershipTeam ManagementTeamworkTechnical SupportTestingTrainingTroubleshootingVaccinesVerification

Skills and Expertise

Self Assessment :
Analytical skills Control data Guide students Report data Analyze data Use content management systemsAdjust processes Administrative supportAnswer, transfer and handle incoming calls as needed.Archive documentationArchive study documentsArchive trial documentation and correspondence.assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist with proceduresAssist with routine testsAttend seminars, courses and meetings within and outside the companyCapture data on source documentsCoach and provide guidance to clinical staff.Communicate effectively on different company levelsControl protocol versionsCreate study documentsData entryData verificationDocument employees training requirementsEnsure consistency between the protocol and CRFEnsure data consistencyEnsure good clinical practice (GCP)Follow up training programsFollow up projectsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesHandle callsGuide staffIdentify and provide training to trial team and associated staffManage Quality Management System (QMS) documentationmanaging a small teamPerform routine testsPlan work to meet objectives and deadlinesProvide trainingQuality control processRetrieve study documentsReview dataReview quality control activitiesReview quality policiesSolve problemsStudy-related documentsSupervise data processingTrain StaffUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Verify dataWork collaboratively with the other members of the clinical research team Work under specific instructionsWork cross-functionallyWork with coordination and data management teamsWriting regulatory documents

Education

  • in Traduction Anglais Italien from Institut Supérieur de Traducteurs et Interprètes (ISTI), Brussels in 2000
  • in Technicien Orthopédique from Lycée Technique D’Alembert, Paris in 1999
  • in Technicien Orthopédique from Katholieke Hogeschool Kempen, Campus Geel in 1996
  • Baccalaureat Européen in Graduate in languages, history and philosophy from European School Mol (1991-1995) in 1995

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    No

Area / Region

Ternat, Belgium

Others

Driving License
  • No