Description
The Senior eClinical Systems Analyst supports clients through the development, maintenance, and closeout of clinical trials using eTMF, Study Start-up, and CTMS systems. The role performs TMF quality reviews, regulatory document compilation for FDA submissions, TMF quality planning and reporting, CTMS data analysis, KPI reporting, inspection-readiness support, and coaching of eClinical Analysts. It requires at least three years of life sciences experience, strong TMF and electronic documentation expertise, knowledge of ICH/GCP and clinical development processes, and proficiency with Microsoft Office.
