Cari Kniola

PRINCIPAL CLINICAL OPERATIONS CONSULTANT

Cari Kniola is a seasoned clinical research leader with more than 25 years of experience supporting clinical programs across development strategy, trial oversight, and execution. Cari has spent her career working to bring structure, foresight, and steady leadership to complex clinical programs. Her expertise lies in anticipating risk and ensuring clinical trials are designed and executed in a way that is both compliant and fit for purpose. She provides a practical approach, clear judgment, and the ability to guide teams through ambiguity without losing focus on quality or outcomes.

Cari’s experience spans multiple therapeutic areas in early development through pivotal and post-market phases, with a consistent focus on operational quality, regulatory integrity, and execution. She has built and scaled clinical trial operations teams from the ground up—hiring and mentoring talent, establishing SOPs and KPIs, and creating processes that are practical and scalable. She brings expertise in cross-functional trial operations and the practical application of ICH GCP/FDA/regional requirements for U.S. and global studies. She regularly partners across clinical, regulatory, quality, data, and commercial groups to align strategy with execution and keep programs moving forward.

For more information, please see her LinkedIn Profile.