Manager, TMF Systems and Operations

Role: Manage and support the daily operations of Moderna’s Clinical Trial Management System (CTMS) and Trial Master File (TMF), ensuring study systems are compliant, accurate, and inspection-ready throughout the clinical trial lifecycle. Responsibilities: execute CTMS activities such as study/site setup, data accuracy, reporting, and troubleshooting; support TMF setup, document filing, quality checks, and serve as TMF Lead for inspection readiness; maintain data integrity across systems, support audit/inspection activities, and collaborate with CROs, vendors, and internal teams to address operational issues. Requirements: Bachelor's degree or equivalent; 6+ years in clinical research, with at least 3 years in TMF/CTMS operations; working knowledge of Veeva Vault Clinical Suite preferred; familiarity with ICH GCP and global documentation standards; strong organizational, communication, and cross-functional collaboration skills. Preferred: experience supporting audits/inspections. High-Value: focus on clinical trial documentation, GxP compliance, inspection readiness, and cross-team vendor collaboration in a biotech/pharma setting. Work setup: not specified.