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This translator is a Pharm.D. in Pharmacy and Biochemistry from University of Sao Paulo and has more than 10 years of translation experience. He is a member of the Society for Clinical Data Management and is currently a Clinical Data Quality Manager at Bristol-Myers Squibb, Brazil. He has advanced knowledge of clinical operations, data management, budget and contracts, SAE/eSAE processing, management and monitoring of clinical trials, onsite monitoring, vendor management, Phase IIV clinical development, post-marketing trials, regulatory compliance, clinical pharmacology, medical writing, drug supply, and IVRS processes.
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.
PhD, Chemistry of polymers, Budapest Technical University, Hungary MSc, Macromolecular chemistry, Budapest Technical University, Hungary Knight Cross of the Order of the Hungarian Republic for "Outstanding Service in Cultural Diplomacy" Permanent translator of the European Patent Office (Vienna) of Japanese scientific and patent literature and of the US Patent and Trademark Office.
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Department of Applied Physics, Faculty of Engineering,Tohoku University Sendai, Japan
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PhD, Muscle Biology, Tohoku University Sendai, Japan BS, Animal Science, Tohoku University Sendai, Japan
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Master degree in Electronic Engineering, National Chiao-Tung University, Taiwan Semiconductor and Integrated Circuit Design, LianCheng Training Center (Corel Drawer/ Corel Painter, AutoCAD, Photoshop/ Illustrator, Dream Weaver / Comic Studio)
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Bachelor's degree in Engineering, Shipbuilding Department, Yokohama National University, Japan
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LL.M., University of Tsukuba (Tokyo, Japan)
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Ph.D., Physics, Heidelberg University, Germany
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Doctor in Biochemical Engineering, University of Hiroshima, Japan Master in Biochemical Engineering, University of Hiroshima, Japan Bachelor in Chemistry, University of Sao Paulo, Brazil Yeast taxonomy (Portugal) Management of Culture Collection (NCYC, UK) Biodeterioration, Biodegradation and Fungi preservation (IMI, UK)
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Department of Pharmacy, Kaohsiung Medical University, Taiwan MBA, Texas State University, United States Pharmacist certificate
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MBA, Harvard University, Boston BA Economics, Keio Univ., Tokyo
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English
翻訳会社
tradução em papel
empresa de traducción
traduzione cartacea
Papierübersetzung
traduction papier
papieren vertaling
ترجمه مقاله
แปลกระดาษ
бумажный перевод
ترجمة ورقية
makale çeviri
Tradutor de Artigos
學術翻譯
학술출판번역
论文翻译
