Sarah possesses over 13 years of industry experience with nine years supporting clinical research programs for medical devices. Since joining Experien Group (now Veranex) in 2020, Sarah has successfully launched several clinical studies, as well as clinical gap assessments and the development of clinical standard operating procedures (SOPs). Sarah has considerable experience with clinical studies from developing clinical strategy and study designs through data analysis and final clinical report generation. She has strong knowledge of capital equipment, implantables, software as a medical device (SaMD), medical instrumentation, and combination products.
At Veranex, Sarah supports clients’ clinical and regulatory projects, including U.S. and international clinical study programs, from early feasibility studies (EFS) to first-in-human (FIH)/feasibility studies (FS) to pivotal trials in pursuit of medical device commercialization. Sarah’s primary functions include:
- Participating on design teams throughout the product life cycle
- Providing input on clinical strategy development to optimize the client’s clinical evidence goals
- Directing clinical elements and generating clinical study documentation required for FDA and OUS regulatory agency submissions, including pre-submission packages and investigational device exemption (IDE) applications, as well as final clinical study reports for 510(k)s, de novos, PMAs, and EU technical files and design dossiers
- Providing clinical study operational leadership, oversight, and support from study planning through close-out and analysis in accordance with projected timelines; this includes study/site activation activities, management of clinical study databases, formulation, and facilitation of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and core labs with the study sponsor to ensure study success
- Conducting clinical QMS gap assessments and developing clinical standard operating procedures (SOPs) and associated forms to standardize company and client practice
Past companies and experience
Sarah has successfully led clinical teams in support of 510(k) submissions for hardware and software, global postmarket registry, real-world evidence strategy for a PMA supplement, and MDD and EU MDR related activities. Sarah has specialized device experience in drug coated balloons, guidewires, aortic stents, accessory vascular devices, cranial and spinal navigation systems, robotic guidance platforms, and surgical tools.
Prior to joining Veranex, Sarah served as a clinical project manager/principle clinical research specialist at Medtronic in the Enabling Technologies division. Sarah was responsible for the design of clinical data acquisition projects for early feasibility studies and algorithm development, as well as support for EU MDD and EU MDR related documentation, evaluation plans, review of CERs, and assessment of Postmarket Clinical Follow-up (PMCF) needs. Sarah previously held various roles of increasing responsibility in the vascular division of Medtronic, where she worked as the global lead for a large postmarket registry, as well as clinical post-acquisition assessment activities. Sarah has also served in various clinical research roles at the University of Colorado, Denver, Parexel International, and the University of California, San Diego. She is an accomplished clinical professional with several co-authored cardiology papers.
Sarah received her B.S. in biochemistry and cell biology from University of California, San Diego and an M.S. in biomedical sciences with a pharmacology focus from University of Colorado, Anschutz Medical Campus. Sarah completed coursework in clinical trial management from UCSD and project management from George Washington University. Sarah earned a fellowship in clinical and translational science from the University of Colorado, Anschutz Medical Campus.