Lily Hsu
Director, Development Systems (Ctms & Etmf) @Corcept Therapeutics
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WORK HISTORY
Director, Development Systems (Ctms & Etmf) @Corcept Therapeutics
Lead the implementation of Corcept’s first in-house CTMS, collaborating with Clinical Operations, IT, and Medidata to define use cases, design processes, establish requirements, and guide configuration.2. Manage the ongoing enhancement of Veeva eTMF, promoting continuous improvement and optimizing business processes and user experience.3. Co-develop and maintain a 3-year CTMS and eTMF roadmap with the IT Head of Business Relationship Management, ensuring alignment with strategic goals and technological advancements.4. Drive cross-functional collaboration (Clinical Operations, Clinical Records, IT) to define data management strategies for CRO CTMS data and eTMF documents.5. Champion process improvement initiatives, in organizational process improvement efforts, identifying potential opportunities to leverage CTMS or its data to improve efficiency and/or compliance6. Collaborate with Clinical Operations and Clinical Records teams to streamline data entry and partner with Quality Assurance to control CTMS data accuracy and eTMF document quality.7. Stay abreast of industry trends, regulatory updates, and GCP standards, providing strategic insights on their implications for CTMS and eTMF systems.
EDUCATION
National Taiwan University
BS, Public Health
Stanford University
MS, Statistics
University of California, Berkeley
Certificate, Project Management
Stanford University School of Medicine
MS, Epidemiology, Health Research and Policy
ABOUT LILY HSU
15 years of experience in clinical, pharmacovigilance, quality, and R&D software…
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