Colleen Holthe

Colleen Holthe currently serves as the Vice President of Clinical Affairs at PQ Bypass. Colleen has over fifteen years of experience in the medical device industry, with a focus on cardiovascular clinical trials.

Colleen began their career as a Clinical Program Manager at Spectranetics in January 2015. In this role, they were responsible for the overall execution and oversight of Global Cardiovascular clinical trials. Colleen led clinical teams of cross functional representatives to ensure expectations and timelines were clearly defined and deliverables were met. Colleen also authored and compiled data for study protocols, annual progress reports, and final reports for both PMA and 510(k) submissions.

In 2016, Colleen served as the clinical team member for Regulatory submissions in Japan. Colleen traveled to Japan to serve as the clinical subject matter expert for Shomen Chosa meeting with PMDA. Additionally, they participated in FDA BIMO inspections by interfacing with the FDA Inspectors on the clinical trials they were responsible for.

Also in 2016, Colleen was responsible for preparing and managing clinical trial budgets by reviewing monthly resourcing data and spend data. Colleen managed resourcing for all functions, across the team. Additionally, they served as the clinical representative on the Product Development Process (PDP) core team by providing updates on the clinical deliverables to ensure the timelines of the overall PDP project were met.

In their current role at PQ Bypass, Colleen is responsible for identifying, overseeing, and resolving compliance issues that are identified internally and externally. Once a compliance issue is identified, they oversee that the issue is resolved in a timely manner. Additionally, they review materials for product launch and assists with of clinical data presentations and manuscripts for publication. Colleen also collaborates with marketing to ensure clinical data is represented in a consistent and clear manner. Finally, Colleen is responsible for content and posting study information and results to clinicaltrials.gov to ensure compliance with reporting requirements and US Public Law 110-85 (FDAAA).

Colleen Holthe has a MPH from the University of Minnesota School of Public Health in Executive Public Health Administration and Policy. Colleen also has a BS from the University of Wisconsin-Eau Claire in Kinesiology/Biology.

Colleen Holthe reports to Richard Ferrari, Chairman of the Board and CEO. They work with Marion Larrea - Vice President, Operations, Ron Steckel - (Acting) Chief Operating Officer, and Heather Simonsen - President.