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Position in clinical operations: • Global Data Manager in Oncology. • CRA in Cardiology, Epilepsy, Vaccines and Oncology. Position in System Analysis and IT solutions: • Computer Technician Specialties: CRA • Monitoring activities following GCP • Design, development, validation and full cleaning of CRFs • Experience of cold chain maintenance Data Manager • Supporting set-up and maintenance of database (DM, safety, clinical) • Control of project performance (quality, objectives and timelines) • Design, review and adaptation of Case Report Forms (CRF) • Use ICD-10, RECIST 1.1, MedDRA , CTCAE v 4 and WHO-ART Dictionaries • Serious Adverse Events (SAE) Reconciliation • Knowledge of CDISC (CDASH/SDTM) • Knowledge of SAS applications System Analysis and IT solutions • Reparation of OS (Windows, Linux and Mac) • Installation of software for medical devices and medical instruments

Experiences

Current Experience

  • Clinical Data Manager (DM)


    Since September 2012
    CDISC ≡ Discrepancy management of clinical data in CRF with Oracle RDC: - Review incoming data, - Generate, review and close queries, - Study Coordinator at site cooperation for CRF completion - CDISC (CDASH/SDTM) knowledge ≡ Liaise with Study Coordinator and CRA at Sponsor: - highlight issues and suggest solutions, - prevent potential quality/safety issues, - follow up of ongoing queries and case discussions - ensure CAPA . ≡ Production of listing and reports ≡ Reconciliation process for Serious Adverse Event (SAE) and safety cases.

Past Experience

  • Data Manager

    July 2012 --- July 2012
    Clinical

  • DM and CRA

    April 2009 --- April 2012
    Clinical Trial

  • DATA MANAGER

    April 2007 --- March 2009
    Data Management

  • Clinical Research Associate (CRA)

    October 2007 --- April 2008
    Compliance

  • Computer Technician

    December 2006 --- October 2007
    Medical Devices

  • Study Manager

    July 2005 --- December 2006
    Adverse Events

  • Clinical Research Associate (CRA)

    October 2004 --- December 2006
    Patient Recruitment

  • Biomolecular Cardiopharmacology Researcher

    September 2001 --- December 2004
    Gene

Knowledge

Self Assessment :
SAS
LinkedIn Assessment :
Clinical trialsGCPClinical researchData ManagementPharmacovigilanceDatabasesMicrosoft OfficeElectronic Data Capture (EDC) Database AdministrationOracle ClinicalCDISCVaccinesMicrosoft ExcelMicrosoft WordSOPGraphic DesignAdobe Creative SuitePhotographyoncologyMedDRAInformatic TechnicianFast LearnerGuitaristCookingTravelComicsExcelWordCDASHCRF designSommelierWine TastingSAS programmingCROSOP

Education

  • MD in Biology from Università degli Studi di Firenze in 2000
  • in from SAS Institute in 0000

Training and Certification

  • SAS ENTERPRISE I in 2014 Training
  • SAS PROGRAMMING I in 2014 Training

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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