Eisai Medical ResearchIT Quality Manager
Jan. 2005 - Dec. 2006• Managed the implementation and compliance of FDA-regulated IT systems including mplementation and validation of a new Global Clinical Database Management System (GCDMS) which integrated Clintrial, Integic CRF Work Manager, iReview, dsNavigator, Crystal Reports and Citrix. • Brought SOPs, operating manuals and guidelines for computer system qualification and validation in line with corporate policies and developed a risk-based IT validation and CFR 21 Part 11 compliance strategy.
• Managed the remediation of gaps in the existing state of IT compliance for GCP systems and the qualified network.