Manager, TMF Systems and Operations
Core
Manage daily operations and maintenance of Moderna's Clinical Trial Management System (CTMS), eTMF, and Trial Master File (TMF) to ensure regulatory compliance and inspection readiness.
Role type
Manager, Clinical Trial Systems Operations
Builds
Operational processes for CTMS/eTMF, study configurations, and data quality dashboards
Domain
Biopharma / Clinical Research Operations
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
CTMS operations, TMF records management, data quality assurance, audit/inspection support, cross-functional collaboration, process improvement, end-user training
Preferred skills
Veeva Vault Clinical Suite, ICH GCP knowledge, audit/inspection experience
Technologies
Veeva Vault Clinical Suite, CTMS, eTMF
Responsibilities
Execute CTMS operational activities (study creation, user provisioning, workflow management); maintain TMF setup and document filing accuracy; support system updates, releases, and UAT; conduct TMF health checks and quality reviews; partner with CROs and vendors to resolve operational issues; provide end-user training and guidance on document filing; support audit and inspection preparation.
Seniority
Manager, hands-on IC with team leadership
