Phase II/III Diabetic Macular Edema (DME) trial Provision of ongoing feedback on Oracle Clinical system validations/eCRF instructions and escalation of any data issues to upper managers.Ĭlinical Research Associate, PPD do Brasil Suporte à Pesquisa Clínica / PPD Intl, Brazil ĝata cleaning, eCRF application (coordination of Data Early Process Control and Ongoing Data Quality Control activities). Training/coaching on CRF/eCRF completion.
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Support sites with account registration for company’s systems. Site support on Serious Adverse Event reporting and follow-up. Performance of clinical listing review per Data Review Plan. Revision of quality metrics and data trends. Manage the data collected from 12 clinical trials distributed among 63 clinical sites in Brazil plus 6 clinical trials conducted in Canada. Played leadership roles in environmental safety, Six Sigma, and CIP (Continuous Improvement Process) projectsĬlinical Data Quality Manager, Bristol-Myers Squibb Company, Brazil Production Technologist, Bayer HealthCare, Berkeley, California Involved in managing constant perfusion fermentation and cell separation systems, operating and troubleshooting ultrafiltration technology and sampling for quality control Bio-technician, Bayer HealthCare, Berkeley, California Ĝoded in Visual Basic, a screening tool that evaluates Katakana drug names for scripted similarities with existing drug names as per Japanese regulatory requirements. Performed in-depth analysis of issues related to prescribing and dispensing, including consulting on all aspects of drug information, from profile to packaging to trade-dress. Provided medication error prevention analysis associated with the labeling of pharmaceuticals, biological products, and medical devices. Ğnsured that drugs met regulatory standards set forth by the FDA, the European Medicines Agency, Health Canada, and the Ministry of Health, Labour and Welfare in Japan. Drug Safety Consultant, Brand Institute, Miami, Florida
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