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Summary

I currently play the role of Clinical Data Quality Manager, Regional Clinical Operations at BMS in Brazil, working in partnership with Clinical Site Managers and Site Monitors on the conduction of clinical trials. Under my responsibilities are the management of data collected from 46 clinical sites in Brazil and 4 clinical sites in Canada, as well as training provision for the site staff assigned in those sites (205 members). Additional tasks include: leadership of an innovation and improvement-driven initiative implemented in Brazil, and assistance for implementation of the same initiative in Latin America and Mexico; participation in a newsletter; eCRF Coach. At R A Traduções, a translation company, I am responsible for the overall corporate management (including Finance and Informatics), assessment of translators, and administrative issues. At Maria Joaquina, a woodworking company, I am responsible for the overall Finance and Informatics management.

Experiences

Current Experience


  • Since June 2014


  • Since October 2013

  • Translation Technical Manager
    Since June 2008
    Translation of Clinical Trial Protocols, Investigator's Brochures, Safety Reports, Regulatory Letters and Documents, Case Report Forms, Informed Consent Forms, Academic Articles. Management, training and follow-up of a team of 192 translators.

  • Finance / Partner
    Since October 2006
    Activities: Responsible for Finance, Administrative and Informatics related issues

Past Experience

  • Clinical Data Quality Manager
    March 2011 --- February 2014
    Support sites with account registration for company’s Oracle Clinical systems, training/coaching on CRF/eCRF completion, data cleaning, eCRF application throughout the study, Core Data Management (coordination of Data Early Process Control and Ongoing Data Quality Control activities), provision of ongoing feedback on Oracle Clinical system validations/eCRF instructions and escalation of any data issues to upper managers, assistance to site staff and company staff (local and global) with data related questions (lead liaison with sites for upper managers), study tracking, assessment of eCRF completion/approval and discrepancy processing, and requesting outstanding data, revision of quality metrics and data trends, performance of clinical listing review per Data Review Plan, site support on Serious Adverse Event reporting and follow-up, close teamwork with Site Monitors, Site Managers and site staff. Additional tasks involve the leadership of a council for innovation (including the assistance on implementing the initiative in Latin America), participation on a local newsletter, assistance on a global time-reporting system (user acceptance testing), eCRF coaching.

  • Clinical Research Associate (CRA)
    October 2007 --- June 2008
    Phase II/III Diabetic Macular Edema (DME) trial. Phase I Anticonvulsant Therapy trial. Phase III Lupus Nephritis trial. Phase II Respiratory Syncytial Virus (RSV) trial. Ensure accuracy of investigators' files and trial master file. Management of study data, including review and tracking of study documents, translation and tracking of submission/notification of Safety Reports, letters and communicates. Maintenance of up-to-date Siebel Oracle Clinical trial management tools to ensure adequate communication to project team and sponsor. Interact with sites and sponsor to discuss project-related issues and provide assistance and follow-up. Prompt support to sponsor and Clinical Trial Manager. Performed site initiation visit, field visits and close-out visit.

  • Jr. Clinical Research Associate
    June 2006 --- October 2007
    Activities: Elaboration of clinical trial protocol, Informed Consent Forms (ICF) and Case Report Forms (CRF) Translation of protocols, ICF, CRF and trial-related manuals Electronic CRF training; certified e-CRF trainer Initiation Visits and Interim Monitoring Visits (IMV), and development of monitoring reports Responsible for organizing and leading the activities of an Investigators' Meeting Responsible for the export logistics of biologic samples to central laboratories Responsible for the import and distribute logistics of investigational products to sites Responsible for the management and report of Serious Adverse Events Management of regulatory aspects, data and biostatistics of clinical trials Management of the company's library Development and improvement of management tools for internal administration, monitoring visits and clinical trials. Creation of electronic CRF, electronic monitoring forms, electronic SAE report and electronic monitoring expenses report form (incorporated to the company's portfolio and SOP, what applicable for each).

Knowledge

LinkedIn Assessment :
Return emails in a timely fashionInformaticsEnthusiastCRF designData OperationsProtocol Data ManagementOracle ApplicationsProject ManagementTeam LeadershipEntrepreneurshipInnovation DevelopmentCustomer ManagementImport/Export OperationsOracle ClinicalI-ReviewJ-ReviewRemote Data CaptureMedDRAeCRFSAE ReconciliationeSAESix SigmaKaizenMicrosoft ExcelVisual BasicGCPcardiovascularDermatologyEndocrinologyOphthalmologyImmunologyTumor ImmunologyInfectious diseasesoncologyHepatologyCorporate DevelopmentImmuno-oncologyCorporate FinanceTechnical TranslationTranslationMedical TranslationClinical researchActive listenerInnovationOut Of the BoxClinical trialsClinical Data Management (CDM)Clinical Site MonitoringData ManagementGlobal Data Management

Education

  • in from Vanderbilt University in 2013
  • in from Universidade de São Paulo in 2009
  • in from in 0
  • in from in 0

Area / Region

Belgium

Others

Driving License
  • No