Julie Saathoff
About Julie Saathoff
Julie Saathoff serves as the Executive Director at Celerion, where she has worked since 2019. With a background in clinical operations and management, she has led significant initiatives, including the global implementation of an electronic Trial Master File application.
Current Role as Executive Director
Julie Saathoff has served as Executive Director at Celerion since 2019. In this role, she oversees various operational aspects of the organization, focusing on enhancing clinical monitoring and trial management processes. She leads a team of 30 professionals located in the US and UK, ensuring effective management and execution of clinical trials. Her leadership emphasizes quality standards and compliance within the clinical monitoring department.
Previous Experience at Celerion
Prior to her current position, Julie Saathoff held multiple roles at Celerion. She was the Director of Clinical Monitoring and TMF Service from 2014 to 2019, where she led the global implementation of an electronic Trial Master File (eTMF) application. Additionally, she served as Sr. Director of Tobacco Operations for one year in 2018-2019 and as Sr. Director of the Lincoln Clinical Site from 2010 to 2014. Her tenure at Celerion spanned nearly a decade, during which she contributed to various operational improvements.
Education and Expertise
Julie Saathoff earned a Bachelor's degree in Mathematics from Nebraska Wesleyan University, completing her studies from 1991 to 1995. Her educational background provides a strong foundation for her analytical and problem-solving skills, which she applies in her current role in clinical operations. Her expertise includes clinical trial management, risk-based monitoring, and the implementation of electronic systems to enhance operational efficiencies.
Professional Background
Before joining Celerion, Julie Saathoff worked at MDS Pharma Services in a Business Development role from 2005 to 2010. This experience contributed to her understanding of the pharmaceutical and clinical research landscape, further informing her subsequent roles in clinical monitoring and operations. Her career trajectory reflects a consistent focus on improving clinical trial processes and compliance.
Leadership in Quality Management
In her current role, Julie Saathoff is responsible for leading quality investigations and managing Corrective and Preventive Actions (CAPAs). She focuses on upholding quality standards within clinical operations, ensuring that processes align with regulatory requirements and best practices. Her leadership in quality management is integral to maintaining the integrity and efficiency of clinical trials at Celerion.