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Experiences

Current Experience

  • Global Project Manager
    Since May 2013

Past Experience

  • International Project Manager
    January 2008 --- March 2013
    Review and approval of study budget, including per subject and ancillary investigator costs Vendor selection and management Country feasibility assessments to ensure appropriate study site selection and site readiness (Clinical Trial Agreements, EC approvals and regulatory documentation) Oversee country resources Overseeing implementation of the investigator meeting by the appropriate groups (e.g., Meeting Planning group, country offices) Ensure that clinical trial IPs are labeled and supplied in a timely manner Track progress to ensure all essential study materials, equipment and documentation are in place for study start (e.g., ethics and regulatory approval, budget, drug supplies, data collection tools) Track metrics to monitor, actively manage and report on the delivery of project team goals Define monitoring visit plan and schedule Responsible for ensuring documented review of MVR to ensure issue/actions are resolved and for ensuring consistent monitoring across the study Completion of responses to audit findings Analyze data query trends and provide feedback to monitoring lines/CRO, LDM, to enable continuous improvement Ensure the quality and completeness of protocol level TMF and any additional regulatory documentation Ensure data flow management Ensure appropriate regulatory approval process is completed where required Review and ensure all key regulatory documentation in place prior to drug release and study initiation Support IRB approval process, subsequent renewals and safety communication In partnership with local regulatory affairs, maintain ongoing communication with Health Authorities NDA SUBMISSION AND INSPECTION READINESS Responsible for driving the RA (Rheumatoid Arthritis) submission timelines across the Program As part of Inspection Readiness efforts in support of the RA submission, was responsible to prepare listings of the monitoring support and country level training documentation across the country offices

  • GSM
    January 2008 --- December 2012

  • Lead CRA
    January 2005 --- October 2007

  • Senior Clinical Research Associate
    April 2002 --- December 2004

Knowledge

LinkedIn Assessment :
Clinical monitoringCTMSEDCCROGCPICH-GCPTherapeutic AreasClinical trialsClinical DevelopmentoncologyClinical Data ManagementRegulatory submissionsInfectious diseasesPharmaceutical IndustryPhase I

Education

  • • Master’s degree in Biological and Medical Science, Faculty of Medicine Lariboisiere, Paris, France in from Faculty of Medicine Odeon - Paris, France in 1999
  • Veterinary in from National Veterinary School - Algiers, Algeria in 1993

Area / Region

Champigny-sur-Marne, France

Others

Driving License
  • No