Stephanie Borzillo

About Stephanie Borzillo

With over seven years of dedicated experience in Trial Master File (TMF) management…

Experience

1. Tmf Manager

   Inseption Group

   Dec 2022 — Present · Lansdale, PA, US

   Responsible and accountable for assisting in the implementation and management of the Trial Master File used tomeet the needs of internal stakeholders and clients. Assist clients in the implementation and management of clinical systems to include, not limited to, eTMF and CTMS. Assist in the Validation and User Acceptance Testing of clinical systems. Participate in the development and creation of TMF Plan and TMF Index, for assigned studies. Perform document process activities such as re-classifying, deleting duplicate documents, editing metadata, andadding and reconciling placeholders for missing documents. Investigate and resolve document issues and escalate situations to Study Team/ Functional Lead. Perform regular and ad hoc quality control checks of assigned TMF studies, provide findings to clients and relevantvendors as applicable and assist in resolution of findings. Provide training on the TMF upload process and document quality expectations for clients and vendors as needed. Conduct initial triage of eTMF system issues and escalate to the support team as needed. Assist with inspections and internal audits, including pre-inspection/audit TMF review and responding toinspection/audit requests and findings. Provide regular and ad hoc TMF metrics and report to clients. Provide and maintain TMF access to internal and external users. Provide project management for clients.