Helen Fasshauer
About Helen Fasshauer
Helen Fasshauer serves as the Senior Director of Clinical Data Management at Sana Biotechnology, where she specializes in EHR to EDC integration and eConsent systems. With an MBA from the University of Phoenix and a Bachelor's in Biology from Georgian Court University, she has extensive experience in clinical data management across multiple organizations.
Current Role at Sana Biotechnology
Helen Fasshauer serves as the Senior Director of Clinical Data Management at Sana Biotechnology, Inc. since 2022. In this role, she supports CAR-T clinical development programs and has been instrumental in creating Case Report Form (CRF) standards. She oversees the Clinical Research Organization (CRO) for clinical database build and has authored Standard Operating Procedures (SOPs) for the Clinical Data Management department. Additionally, she has built the Clinical Data Management department and established processes to enhance operational efficiency.
Previous Experience in Clinical Data Management
Prior to her current position, Helen Fasshauer held significant roles in clinical data management. She worked at Constellation Pharmaceuticals as Senior Director of Clinical Data Management from 2019 to 2022. Before that, she spent five years at Takeda as Director of Clinical Data Solutions from 2014 to 2019. Her earlier career includes various positions at Covance, where she progressed from Associate Director to Director of Clinical Data Management between 2001 and 2014.
Education and Expertise
Helen Fasshauer holds an MBA from the University of Phoenix, where she studied Business. She also earned a Bachelor of Science degree in Biology from Georgian Court University. Her expertise includes EHR to EDC integration and eConsent systems, which are critical in modern clinical trials and data management.
Certifications and Professional Development
Helen Fasshauer holds a Six Sigma Green Belt certification, which demonstrates her proficiency in process improvement methodologies. This certification reflects her commitment to enhancing operational processes within clinical data management and her ability to implement effective strategies for efficiency.