Clinical Systems Analyst/ Senior Business Analyst
Irvine, California, United States
Worked directly with external and internal users, to provide support for multiple Clinical Systems. Assisted Operations Teams and Project Managers with the design and conduct of Clinical Trials. Held periodic training sessions for best practices, feature enhancements, and for new employee orientations. Helped the Technical Support teams with identifying, logging, tracking, and resolving Clinical System anomalies.• Functioned as the SME for Clinical Trial design, EDC Clinical Systems, new feature enhancements, and clinical data integrations. Facilitated EDC data collection standards, guidelines, and principles. • Published the DataLabs EDC Best Practices Guide, which included Edit Checks (Queries), Derivation Scripts, pScripts (Publication Scripts), and reusable (common) Function Scripts. • Assisted with the design and validation of Clinical Data Systems & Tools, providing support to the operations teams, from preliminary eCRF design & Edit Check coding through database lock.. • Developed the full set of requirement specifications & UI design for a proposed Clinical Study Library feature. • As Product Owner, expedited the design, development, testing, and launch of a new web-based clinical application which was urgently needed to replace an outdated desktop tool. This project was completed 1 month ahead of schedule, 15% under budget, and significantly exceeded customer expectations. • Worked with a team of System Engineers, IT, & Vendors to redesign/enhance the coding integration workflow. This complex system included data entry of the EDC verbatim term,Coding Dictionary association, auto-Coding, and confirmation of the Coding response back to EDC. Software: DataLabs Designer (Clinical Trial Design System), DataLabs EDC (Electronic Data Capture), IMPACT CTMS (Clinical Trial Management System), ClinPhone RTSM (Randomization & Trial Supply Management), SharePoint, Information Builders WebFOCUS InfoAssist, SAS, SQL, & Talisma CRM