Caroline Nielson

Caroline is the Associate Director of TMF Operations at 4D Molecular Therapeutics, where she develops and leads the execution of TMF and clinical document management strategies, designs and implements TMF metrics programs, and oversees various CROs working within the Sponsor TMF system. Her background is in financial analysis and reporting and she possesses a deep passion for data analysis and spreadsheet applications. She was first introduced to the TMF Reference Model when she was contracted to design and implement a performance-based payment system for various roles related to the Trial Master File (TMF). Since then, she has emerged as a leader in roles related to the Trial Master File, Quality Systems, and Clinical Solutions and Compliance. She has successfully managed global eTMF systems, overseen TMF migrations from CRO to Sponsor, and has built and led TMF teams of various sizes.