Mallorie Sayre

Experience

1. Associate Director, Clinical Systems Operations and Support

   Moderna

   Apr 2020 — Present

   Business owner (Vault Owner role) of the Veeva Vault Clinical, creates and maintains Clinical Systems SOPs and controlled documents, including training materials Authors and maintains job description for the Moderna TMF team roles (including third party consultant’s equivalent JDs) Manages and provides clear documentation of third-party oversight for Moderna’s TMF consultants at a study and portfolio level.(One consulting firm, approximately 25 consultants) Maintains effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance, close-out, and archive Drives the implementation, update and review of eTMF System-related documents and controlled procedures/ SOPs Manages configuration change requests in eTMF systems on lifecycles, workflows, security settings, permission settings, objects, document types and subtypes Attends portfolio, departmental, and study-specific meetings and discussions, as required Runs routine eTMF reports and monitors TMFs for completeness, KPIs, metrics, and trends Performs general administrative tasks, including but not limited to user access, vendor release review, configuration/enhancements, integrations, AI/ML projects, and validation activities. Ensures adherence to record retention schedules according to records retention policy Maintains an inspection ready TMF and trains study teams on what inspections ready means and expectations for each role to work towards this goal Represents function during regulatory inspections, audits, and process improvement initiatives, as needed. o Preformed as TMF SME all Moderna inspections (e.g, PMDA, FDA, etc.) Business owner of Regulated DocuSign (21 CFR Part 11), creates and maintains SOPs and controlled documents, including training materials.