Milena Tostes

Experience

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  EMS

  Jul 2002 - Dec 2003

  Purchase Development Analyst

  Purchasing Development Department: development of suppliers of new raw materials, managing quality, price and documentations and also supporting the R&D, Marketing, Quality Control and Regulatory Departments.

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  Laboratórios Ariston Ltda

  Jan 2004 - Sept 2004

  Foreign Trade Analyst

  Trade Foreign Department: development of news suppliers, importing raw materials, making dossier for products registration in others countries and exporting finished products.

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  Bachema AG

  Jul 2005 - Jul 2007

  Chemical Analyst

  Analysis of soil and water samples; expertise in: ion-chromatography (HPLC), electronic- spectroscopy assays (cyanide, phenol, nitrite, phosphate, ammonium), Total and Dissolved Organic Carbon and Limsophy.

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  ICON plc

  Mar 2008 - Apr 2012

  Pre study, site initiation, monitoring and close-out visits onsite Monitoring visits in MexicoFeasibility process Investigator contract negotiation Payment procedures and investigator file and local study file review Query resolution, DBL and IVRS Clinical Trial Assistant

  • Clinical Research Associate

    Jan 2010 - Apr 2012

  • Clinical Trial Assistant

    Mar 2008 - Jan 2010
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  Parexel

  May 2012 - Jan 2023

  Pre study, site initiation, monitoring and close-out visits onsite Monitoring visits in Colombia and Argentina.Assessment visits of less experience CRAsCoaching to a Jr. CRAsMonitoring Visit Reports review from another countries (Israel, Spain, Canada and Brazil)Data Cleaning metrics analysis and review of issues resolutionPlanning and coordinating other CRAs and in-office CRAs within study teams mainly in studies with the Clinical Trial Manager is located abroadNegotiating metrics and timelines with Study team and sitesExperience in Inspection Readiness on-site Audit Show less

  • Clinical Operations Leader

    Apr 2021 - Jan 2023

  • Associate Clinical Operations Leader

    Oct 2019 - Mar 2021

  • Senior Clinical Research Associate

    May 2015 - Sept 2019

  • Clinical Research Associate

    May 2012 - Jun 2015