Brazil

10+

Doctor of Pharmacy (Pharm.D.), Pharmacy and Biochemistry,
Universidade de Sao Paulo, Sao Paulo, SP, Brazil
Data Management for Clinical Research, Vanderbilt University, USA

Clinical Data Quality Manager, Bristol-Myers Squibb Company, Brazil
- Manage the data collected from 12 clinical trials distributed among 63 clinical sites in Brazil plus 6 clinical trials conducted in Canada.
- 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.
- Support sites with account registration for company\'s systems.
- Training/coaching on CRF/eCRF completion.
- Data cleaning, eCRF application (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.

Clinical Research Associate, PPD do Brasil Suporte a Pesquisa Clinica / PPD Intl, Brazil
- 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

Jr. Clinical Research Associate, AAIPharma/IPCSP, Brazil
- Elaboration of clinical trial protocol, Informed Consent Forms (ICF) and Case Report Forms (CRF).
- Translation of protocols, ICF, paper CRFs and trial-related manuals and contracts.
- Electronic CRF training; certified e-CRF trainer Site Initiation Visits and Interim Monitoring Visits (IMV), monitoring reports, management and report of Serious Adverse Events, regulatory management, import and distribution of investigational products to sites, export of biological samples to central laboratories, clinical data management, organization and leadership of an Investigators\' Meeting.
- Development and improvement of management tools for internal administration, monitoring visits and clinical trials.
- Creation of electronic CRF, electronic monitoring forms, electronic SAE report form and electronic monitoring expenses report form (incorporated to the company\'s portfolio and SOP).
Translation Technical Manager, R A Services de Tradues Medicas e Cientificas Ltda, Brazil
- 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.
- Management of the company and assignment of duties to employees.