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
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).
in from Vanderbilt University in 2013
in from Universidade de São Paulo in 2009
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