Beth Olen

Principal Clinical Data Manager

Beth Olen

Principal Clinical Data Manager

A proven Clinical Data Manager with 17 years of data handling experience and more than 9 years of rare disease experience, Ms. Olen has focused her expertise on both cystic fibrosis (3 years) and sickle cell (6 years) diseases.

Currently, she is managing the clinical data management cleaning activities on a long-running (> 5 year) sickle cell gene therapy study with numerous protocol amendments (currently on #9). Ms. Olen is familiar with designing CRFs for procedures like mobilization, apheresis, and other assessments associated with stem cell transplants, and she has also designed EDC databases for complex protocols with dose-escalating cohorts and multiple treatment arms. Over the course of her career in rare disease, Ms. Olen has developed expertise with many scales, including CFQ-R Cystic Fibrosis-Questionnaire-Revised, CSSRS – Columbia-Suicide Severity Rating Scale, PROMIS-57, PROMIS Short Form 6A, and the EQ-5D-3L Scale.

Ms. Olen is certified in Medidata Rave Study Build and Design Essentials. She provides leadership and direction for all data management deliverables, including responsibility for the design of the electronic data capture system, database cleaning, and overall management of the flow of clinical data. She possesses great attention to detail, and displays particular proficiency in data management quality control activities, which helps ensure high quality databases with low error rates.

Ms. Olen earned a bachelor’s degree in Interpersonal and Organizational Communication from the University of North Carolina at Chapel Hill.

Why sickle cell?

“I have always felt SCD patients are subjected to negative stereotypes and biases from racial and ethnic inequality in the healthcare system. Now, because I’m fortunate enough to work directly with investigators and site staff who have dedicated their careers to treat and care for SCD patients, I’m able to more closely monitor and even positively affect that inequality, which remains a compelling aspect of my work in sickle cell.”

This is what drives Beth:

 “Knowing that my small role as a data manager on this study contributes toward research that may advance the available treatment options for this underserved population … that makes me feel like I’m making a difference.”