Emmanuel Louis

Sr Clinical System Administrator @OPKO Health, Inc.

Miami, TX, US

Developed electronic case report forms (eCRF) and implemented edit checks within an electronic data capture (EDC) systems.2. Support post-production (screens and edit checks) system modifications.3. Help data coordinators with the creation of CRFMP (Screen specifications).4. Conducted user acceptance testing on screens, edit checks, IXRS integration, local lab setup, email notification, calculations, roles & rights, and electronic uploads.5. Program QC Ad-hoc listing/reports in SQL or Java to help with study cleaning for interim and final study lock (data review and query management).6. Integrated a CTMS system with an EDC system via an integration specification document.7. Created specifications for data transfers (labs, continuous ECG) – reviewed each transfer to ensure validity.8. Implemented local laboratory setup within an EDC system and overseen the loading of an electronic transfer.9. Responsible for the Administration and accuracy of the eTMF system (TMF Reference Model 3.0).10. Programmatically created DSMB listing reports for a phase 1 study.11. Responsible for archiving all latest CDASH, SDTM IG, ADaM IG and there controlled terminology documents for the study team – (library management).12. Review Pinnacle 21 report to classify issues that can be resolved or report as unresolvable issues on the Define.xml reviewer’s guide for SDTM and ADaM.13. Responsible for the review of study deliverables. Deliverables includes:SDTM Specification Document (authored and reviewed), SDTM dataset review, SDTM openCDISC review, ADaM Specification Document (authored and reviewed), ADaM dataset review, ADaM openCDISC review, tables and listings, study plot charts, quality control documentation (authored), Define.xml review.

Miami Dade College

Associates of Arts, Business Administration

Florida International University

Bachelor's degree, Information Technology