Senior Clinical Operations Manager with extensive experience in TMF Operations. TMF SME with experience in both sponsor and CRO settings, including launching TMF department and full scope of knowledge using eTMF Veeva Vault from clinical trial inception through close out. Authored TMF plans, TMF Index, Veeva Vault Work Instructions/SOPs, File Naming Convention Guidelines, BIMO trackers for FDA Inspections, TMF KPI Metrics, CAPAs and Audit Reports.
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