Shana Ross

Bio:

Shana Ross is a Senior TMF Manager with extensive experience in trial master file (TMF) quality, inspection readiness, and clinical operations across both sponsor and CRO environments. She specializes in TMF completeness, risk-based review methodologies, and the development of scalable quality processes to support global clinical trials and ensure inspection-ready documentation throughout the clinical data lifecycle.

She began her career in human subject protection, working with both local and central Institutional Review Boards (IRBs), where she developed a strong foundation in regulatory compliance and a lasting focus on patient safety and data integrity.

Prior to her current role, Shana served as Director of TMF Operations at a CRO, where she led TMF strategy and execution across multiple strategic partnerships, supporting consistent delivery and quality across diverse clinical programs. This experience brings a dual perspective on sponsor expectations and CRO delivery, enabling her to drive more effective oversight, collaboration, and process optimization.

In her current role, Shana focuses on enhancing TMF quality through structured review frameworks, strengthening query management practices, and improving CRO performance oversight. As a Business Process Owner, she leads and leverages a Functional Service Provider (FSP) model to execute completeness quality reviews, enabling scalable, consistent delivery across studies and supporting more proactive identification of TMF gaps and data quality risks.

Shana holds a Master’s degree in Regulatory Affairs from Northeastern University, with a focus on FDA regulations across drugs, biologics, and medical devices.