Semhal Woldeabe
About
Semhal Woldeabe is from Cary, North Carolina, United States. Semhal works in the following industries: "Pharmaceuticals". Semhal is currently Manager, TMF Compliance - TMF Operations at Syneos Health, located in Morrisville, North Carolina, United States. In Semhal's previous role as a Lead TMF Compliance Specialist at Syneos Health (Previously INC Research/inVentiv Health), Semhal worked in Morrisville, North Carolina until Apr 2021. Prior to joining Syneos Health (Previously INC Research/inVentiv Health), Semhal was a Trial Master File (TMF) Compliance Specialist, at Syneos Health (Previously INC Research/inVentiv Health) and held the position of Trial Master File (TMF) Compliance Specialist, at Raleigh-Durham, North Carolina Area. Prior to that, Semhal was a Project Specialist at Syneos Health (Previously INC Research/inVentiv Health), based in Raleigh-Durham, North Carolina Area from Aug 2017 to Mar 2018. Semhal started working as Pharmacy Technician at Duke Regional Hospital in Raleigh-Durham, North Carolina Area in Jun 2015. From Jan 2010 to Aug 2013, Semhal was Process Technician at Cree, based in Raleigh-Durham, North Carolina Area. Prior to that, Semhal was a Research Assistant at 3M, based in Greater Minneapolis-St. Paul Area from Jul 2007 to Dec 2009.
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Semhal Woldeabe's current jobs
Semhal Woldeabe's past jobs
• In collaborate with study teams, create the standard core TMF structure and ensure a clear understanding of what documents are required (expected), what has been uploaded to eTMF (actual), and the gap between the expected and the actual is in order to prepare studies for inspection readiness. • Generate a status report for documents in studies and communicate the gap analysis with the study team. • Train study teams how to perform eTMF inspections and completeness checks
• Inspect highest priority studies to provide TMF gap analysis. • Review, identify and QC essential regulatory documents that are to be filed in the TMF in preparation for MHRA inspection.