As business analyst in Biogen Idec, I participated in some large-scale projects, for example, Implement and Validate UNIX SAS 9.3 as well as the upgrade of the production servers’ hardware for the biostatistics department and R&D IT Clinical LOT Release.
I build reporting capability for CTMS (Clinical Trial Management System).
I Collaborate with consultants and vendors to prepare validation deliverables and execute test scripts, developing and maintaining change control documentation for GXP systems to achieve FDA 21 CFR Part 11 compliance(Deliverables and Test Scripts includes: Functional Specification, Infrastructure Requirements, Backup and Restore Requirements, Design Specification, System Test Scripts, Backup and Restore Test Scripts, Test Plan, Installation Plan and Qualification, Test Plan UAT Test Scripts , Test Report and SOP).
I collaborate with the Team to prepare for the system go-live and testing and follow up with issues after it go-live.
I am proficient in Unix SAS, Crystal Reports Server, Web SDM, CMdR and East Installation, troubleshooting and Configuration.