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Experiences

Current Experience

  • Clinical Study Manager
    Since July 2016

    Main activities include : • Coordinate study-related activities for Phase III clinical study • Writing and review of study-related documentation: Protocols, Case Report Form, Investigator Brochure, Informed Consent Form, Standard Operating Procedures, Study Procedure Manuals... • Perform Ethics Committees' submission • Help build the strategy for patients recruitment • Participate in site selection and initiation visits • Manage activities and interactions with CROs • Ensure adherence to protocols and procedures • Supervise monitoring activities and logistical aspects of the clinical trial

  • Professeur Invité
    Since January 2015
    Terminologie médicale en langue anglaise dans la catégorie économique Anglais spécifique dans la catégorie paramédicale

  • Owner
    Since January 2015
    Animatrice d'ateliers de loisir créatifs : Carterie, Scrapbooking, Home Décor, ... Distributrice des produits Scrap Plaisir kallimacreation.blogspot.com https://www.facebook.com/KallimaCreation http://www.scrap-plaisir.com/fr/l-e-catalogue-scrapplaisir-c-3/

Past Experience

  • Senior Project Manager
    January 2015 --- June 2016
    • Coordinate projects under his/her responsibility effectively across the operational departments • Design and implement solutions to answer customer’s request • Provide operational input and design solutions for projects to the Sales Executive • Act as primary contact and final responsible person between the customer and the B&C operational departments to ensure customer satisfaction • Ensure that B&C services are delivered on time, within budget and according to the agreed quality standards • Assign and check work related to projects under his/her responsibility • Take part in the overall improvements of internal processes and systems • Keep an eye on industry innovations that may be used to improve B&C processes and systems

  • Project Coordinator Production
    February 2013 --- January 2015
    - coordinate studies/projects effectively within the production department - ensure that B&C services are delivered on time, on budget and to agreed quality standards - act as key interface and final responsible person between the customer and the B&C operational department

  • Project Manager
    December 2009 --- January 2013
    • Coordination of CDISC SDTM conversion projects • Liaison with clients • Set-up and planning of the project activities in collaboration with the project team. • Ensure the project team complies with all applicable SOPs and sponsor agreements • Management of the project team with regard to the project work. • Set-up and management of resource requirements for assigned projects • Generation of proposals • Budget monitoring • Follow-up of Timelines

  • CDASH Team Member
    February 2011 --- December 2012

  • Data Integration Specialist
    February 2009 --- December 2009
    Creation of CDISC STDM Conversion Definition Creation of Define.xml QC of mapping tables, STDM datasets and metadata

  • Data Manager
    August 2007 --- January 2009
    I was responsible for the cleaning of the clinical database at GSK Biologicals : • Run automatic checks to identify inconsistencies in the clinical database • Generate and review data queries • Assure the completeness, the accuracy and the consistency of all data in the clinical database • Do the reconciliation with external lab data

  • Clinical Safety Associate
    May 2007 --- August 2007
    Process data and write narratives in the Safety database Verify the accuracy, the completeness and the consistency of the data

  • Mathematic Teacher
    November 2005 --- June 2006

Personality

Self Assessment :
Analytical thinkingAssertivenessAttention to detailCoordinationInterest in knowledgeOrganizationProactivityProblem solving

Knowledge

LinkedIn Assessment :
CROData ManagementClinical trialsClinical Data ManagementCDISCClinical researchGCPProject ManagementLifesciencesICH-GCPPharmaceutical IndustrySDTMQuality AssuranceClinical DevelopmentSAS programmingSASLife SciencesProtocolDatabasesCDASHEDCCTMS21 CFR Part 11SOPAnnex 13GMPTeam ManagementGDPClinical Trial SupplyBio logisticTeam LeadershipTeachingQuality ControlStandard Operating Procedure (SOP)Good Clinical Practice (GCP)

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Design case record forms Interact with nurses Interact with physiciansAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsAdminister, maintain and co-ordinate the logistical aspects of clinical trialsApprove consent documentsApprove monitoring reportsAssist study siteAttend investigator meetingConduct studiesEnsure good clinical practice (GCP)

Education

  • Master in Biomedical Sciences from Université catholique de Louvain in 2005

Languages

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

Area / Region

Belgium

Others

Driving License
  • Yes