Real-World Evidence & Data-Analytics
Clinical Data Manager
Bethesda, United States
Jamie A. Christian Ramsey is a Clinical Data Manager (CDM) in Real-World Evidence, located in Pharmerit’s Bethesda office. She has over 19 years of clinical research experience of which 13 years have been in Clinical Data Management. Her expertise includes the establishment of Clinical Data Management & Clinical Safety with an organization, standards and procedures development, U.S. and Global Phase I – IV study development thru database lock/unlock, Electronic Database Capture (EDC) selection and case report form (CRF) design, project management, vendor selection and management, CDM auditing activities, study document management, data trending, review and cleaning. Therapeutic experience includes: Respiratory, Oncology, Medical Device, Vaccines, Respiratory, Immunology, Orthopedic, Spine, Sports Medicine, Epidemiology, Ophthalmology and Over the Counter (OTC) Medications, Safety Experience in Phase I-IV, OTC, Monographs and Cosmetics.
Prior to joining Pharmerit, Jamie worked in several industries across a breadth of roles including Manager of Clinical Data Management, Senior CDM and CDM Project Lead, Drug Safety and Surveillance Consultant, and performed Preclinical and Post Market Research as a Chemist and Microbiologist. Over the course of her career she has been involved in transitioning paper based clinical study organization to electronic data capture systems to reduce study development times, MedDRA and WhoDrug coding created standard libraries (paper based and within EDC), implementation of CDISC SDTM, Sponsor Investigator Initiated study selection, auditing, clinical study database training, mentoring, co-lead in the development of standards review committees within an organization for clinical studies, panel preparation committee for NDA, assisting in clinical study reports (CSRs) content writing and review.
Jamie holds a Bachelor of Science degree in Microbiology from Auburn University of Montgomery and an MBA with a concentration in Health Informatics from Southern New Hampshire University.