BioPharm Sytems (Contracted to Medidata Solutions)Senior Project Analyst
Sep. 2006 - Mar. 2010HomebasedImplemented EDC software for multiple pharmaceutical companies, managing EDC requirements gathering, deliverable approval, and post-implementation Hypercare. Conducted validation for platform updates, change control, and process improvement, utilizing strong data and project management skills to guide EDC configuration and system updates. Key Contributions: Set up and validated Oracle suite applications for client protocols (TMS, AERS, RDC), documenting installations and testing. Hired by BioPharm Systems to provide EDC consulting services, building eCRFs for the Rave EDC system, creating schedules of visits, patient calendars, and study timelines. Applied federal guideline verbatim and techniques in building studies, with expertise in Study Data Tabulation Model (SDTM) and Clinical Data Interchange Standards Consortium (CDISC). Conducted Rave Core Configuration setup and implementation before study build.