Design Manager
CurrentDesign and support IXRS systems for clinical trials• Work directly with pharmaceutical and biotechnology study teams including clinical trial managers, inventory managers, biostatisticians, and data analysts• Thoroughly review clinical trial protocols• Gather requirements for IRT (IVRS/IWRS/IXRS) systems• Design complex modules using Visio flows• Write randomization specifications• Document study visit schedules• Document inventory requirements• Create drug dispensation tables, including calculations and titration• Consult on specifications for EDC, CTMS, and shipper integrations• Work with developers and testers to ensure adherence to software design• Conduct User Acceptance Testing (UAT)• Support double-blind and open-label studies, all phases• Support US and international studies with multiple languages• Handle initial builds and amendments• Support multiple studies concurrently• Adhere to Good Documentation Practice and other GxP• Provide intensive mentoring