Banu Ogan
Clinical Document Specialist @Ultragenyx
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WORK HISTORY
Clinical Document Specialist @Ultragenyx
Ensured regulatory compliance of clinical trial documents by collecting, reviewing, maintaining, and archiving according to ICH-GCP guidelines and regulations.Developed systems for Expected Documents Lists (EDL) reviews and drafted training documents for internal teams and CROs to ensure accurate and inspection ready TMFs. Created comprehensive Reports and Dashboards in Veeva Vault to run study reports and metrics. Instigated internal Records Management and CRO dialogue to understand quality, completeness and timeliness risks.
EDUCATION
University of North Carolina at Chapel Hill
Bachelor of Arts - BA
ABOUT BANU OGAN
With nearly five years of experience in the clinical research industry, I am a…
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