Engage in Data Monitoring and Management (DMM) activities, including data review, query management, and investigating logic check flags.
Ensure the quality of database design through documentation, testing, validation, and implementation of clinical data collection tools or systems.
Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.
Adhere to applicable Standard Operating Procedures (SOPs) and working practices.
Collaborate with Study Team Points of Contact, Document Owners, and Trial Master File (TMF) Study Owners to resolve document-related discrepancies and issues.
Contribute to process improvement initiatives and additional projects as they arise.
Qualification & Experience
BA/BS with any years of experience
Demonstrated experience of ICH/GCP (International Council for Harmonization/Good Clinical Practice) documentation requirements
Hands-on experience with electronic documentation management systems and/or web-based data management systems