Carol Federline is Senior Clinical Document Manager at Ocular Therapeutix, where she supports compliant, inspection-ready clinical trial documentation. She has more than 12 years of experience across clinical operations, Trial Master File management, regulatory records, quality control, and document systems. Her work focuses on transforming complex regulatory requirements into practical workflows, strengthening data governance, and identifying documentation risks before they affect trial quality or readiness. Carol has held TMF leadership and consulting roles with Syndax Pharmaceuticals, Bicycle Therapeutics, Phlexglobal/Cencora, Immunocore, Chimerix, Urovant Sciences, and Syneos Health. Across these roles, she has overseen file setup, completeness reviews, quality processes, audits, inspections, archival, and team training. She is also committed to mentoring colleagues and building TMF practices that protect trial integrity, support submissions, and help research teams deliver new therapies efficiently.