Electronic Trial Master File (eTMF)

Detail-oriented TMF Document Specialist with strong over 4 years of foundational experience in managing electronic Trial Master File (eTMF) systems and clinical trial documentation processes. ● Adept at maintaining document integrity, ensuring regulatory compliance with GCP & ICH guidelines & supporting trial teams with accurate document uploads. ● Proficient in conducting quality control (QC) reviews to guarantee document accuracy, compliance with study protocols, and proper filing within the eTMF system. ● Capable of troubleshooting technical issues within eTMF systems and resolving operational challenges promptly to maintain smooth system functionality. ● Focused on continuous improvement of document management processes to enhance efficiency & productivity.