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Summary

i worked for quintiles since 2008 and was involved in multiple Clinical trials using edc processes (inform 4.5/4.6, clintrial, oracle) in various Therapeutic Areas (Neurology, oncology). i acted as data Operations Coordinator with different responsibilities on two Phase III studies ( inform 4.6 and clintrial system) and one Phase II study (same cdms). the main responsibility is providing comprehensive data management expertise to a data management team in delivering quality data management products that meet customer needs: review of system-generated queries, coding, external data discrepancies, sae reconciliation, generation and review of data listing, Data cleaning, Validation of edit checks, development and entry of test cases. additional responsibilities include liaising with the Project Management and clinical teams and third party vendors on a data management level. i am now acting as study Data Manager at gsk: i coordinate all Clinical Data Management activities. i work closely with biostatistic, medical Expert, programmers and the clinical team from the science)" >Protocol approval to the study end. electronic diary cards & tablets: involved from the vendor selection to day to day activities, including the set up.

clinical area: Neurology (parkinson disease), oncology, hiv, copd, ebola

Experiences

Current Experience

  • Study data manager, Consultant


    Since October 2012
    study Data Manager, Study data Manager,

  • SDM for GSK Vaccines (Clinical Research & Translational Science Portfolio)


    Since October 2012
    i am acting as study Data Manager at gsk: i coordinate all Clinical Data Management activities. i work closely with biostatistic, medical Expert, programmers and the clinical team from the science)" rel="nofollow">Protocol approval to the study end. i am working on several therapeutics area for "first time on human" projects as data managment Leader for about 10 studies I am acting as Study Data Manager at GSK: I coordinate all clinical data management activities. I work closely with biostatistic, medical expert, programmers and the clinical team from the protocol approval to the study end. I am working on several therapeutics area for "First time on human" projects as Data Managment leader for about 10 studies

Past Experience

  • Data Operations Coordinator

    October 2008 --- September 2012
    i worked for quintiles since 2008 and was involved in multiple Clinical trials using edc processes (inform 4.5/4.6, clintrial, oracle) in various Therapeutic Areas (Neurology, oncology). i acted as data Operations Coordinator with different responsibilities on two Phase III studies ( inform 4.6 and clintrial system) and one Phase II study (same cdms). the main responsibility is providing comprehensive Data Management expertise to a Data Management team in delivering quality Data Management products that meet customer needs: review of system-generated queries, coding, external data discrepancies, sae reconciliation, generation and review of data listing, Data cleaning, Validation of edit checks, development and entry of test cases. additional responsibilities include liaising with the Project Management and clinical teams and third party vendors on a Data Management level.

  • Technicienne de laboratoire

    January 2002 --- January 2008
    technicienne de laboratoire d’analyses médicales (laboratoire saint julien, caen) >> travail en équipe, au contact du public et des professionnels de santé >> certificat de préleveur sanguin

Knowledge

LinkedIn Assessment :
EDCClinical Data ManagementData ManagementeCRFClinical trialsProtocolLaboratory Skills21 CFR Part 11MedDRACROICH-GCPPhase Forward InFormOracle ClinicalProject Oversight

Education

  • Licence professionnelle Essai clinique et validation, Industrie parmaceutique in from Université de Poitiers in 2009
  • Licence de biochimie in from Université de Caen Basse Normandie / Universite de Caen in 2003
  • in from IUT Génie Biologique in 2002

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    Yes

Area / Region

Saint-Malo, France

Others

Driving License
  • Yes

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