Sholeh Ehdaivand-Komegay ’00

Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes have made her a leader and trusted expert. Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation, and regulatory inspection preparation and participation.

Sholeh is currently Principal Consultant and President and CEO of LMK Clinical Research. She is also the Facilitator for the Metrics Champion Consortium’s (MCC) TMF initiative. In this role, she is leading a group of cross-functional experts to develop and implement TMF metrics and processes.

She received her Bachelor of Arts degree, with a major in Health Care Administration, from Mary Baldwin in 2000. Additionally, she received a certificate for Executive Management for Entrepreneurs from the Tuck School of Business at Dartmouth. When Sholeh is not busy with LMK, she is active in her community, participating in a number of charitable organizations, including Make-A-Wish, Junior League of Charlotte, and Jack and Jill of America.