Eddie O

About Eddie O

Experienced Senior Clinical Data Manager with a proven track record of successfully…

Experience

1. Senior Clinical Data Manager

   SK Life Science, Inc.

   Mar 2019 — Present

   Manage DM activities performed at CRO and vendors to ensure delivery against contracted scope of work• Provide timely and professional ongoing management of clinical trial data perfumed the CRO to the managements by preparing validation plans and chairing meetings• Perform protocol training to the CRO and vendor during study startup and communicate resource issues and timeline to manager• Manage data and related deliverables for a portfolio of studies, tracking timelines and deliverables• Manage custom software configuration and database building with strong understanding of clinical study protocol schedule of assessments• Provide input and participates in development of clinical study documents including protocol and monitoring plans• Create manual discrepancies and facilitate and coordinate tele-conference meeting with CROs to update on project metrics• Ensure UAT is carried out and documented including creating UAT script for testing data entry screens and edit checks• Monitor discrepancy management to ensure appropriate quality of data by regular checks during study conduct versus the data quality plan• Review data to gain understanding and knowledge of the study to accurately assess study status and data quality• Assist the database administrator with the design of the clinical study database in accordance with relevant procedures• Organize electronic data loading and run batch validations while working with IT staff to address technical problems or system enhancements affecting data systems• Actively participate in study meetings, implement data management learning and contribute to activities to improve and maintain the quality and effectiveness of data management processes within the function• Review and process clinical trial data to ensure the accuracy and consistency of clinical trial database• Managed custom software configuration and database building with strong understanding of clinical study protocol schedule of assessments