Marielle Hewitt

Marielle Hewitt is a seasoned professional in clinical research and trial management with extensive experience in the industry. Currently serving as a TMF Support Analyst at LMK Clinical Research Consulting since October 2019, Marielle specializes in TMF QC and remediation for various Sponsors and CROs, demonstrating a strong knowledge of the DIA eTMF Reference Model. Prior roles at Tandem Diabetes Care included positions in Global Post Market Surveillance, while previous experience as Clinical Research Manager at Toolbox Medical Innovations involved developing eTMF structures and contributing to successful ISO audits. Marielle has a proven track record in process improvement, team training, and effective study management, having worked with notable organizations such as PRA Health Sciences and Quintiles, where responsibilities spanned site selection and regulatory compliance. Marielle holds a BA in Psychology from San Diego State University and attended UC San Diego for further education in 2012.