Clinical Systems Specialist
Core
Administer, configure, and support Veeva eTMF and Veeva CTMS platforms to ensure inspection readiness and operational excellence in clinical studies.
Role type
Clinical Systems Specialist (Veeva eTMF/CTMS)
Builds
Inspection-ready clinical systems and optimized trial execution workflows
Domain
Life Sciences / Clinical Operations / Regulated GxP Environment
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Veeva eTMF administration, Veeva CTMS configuration, user access management, system validation, data quality monitoring, report generation, workflow automation, regulatory compliance, stakeholder training
Preferred skills
Veeva Vault certification, TMF health remediation, system migration experience
Technologies
Veeva eTMF, Veeva CTMS, Microsoft Office (Excel, PowerPoint, Teams, SharePoint)
Responsibilities
Administer user accounts and roles for eTMF/CTMS; Configure system objects, workflows, and dashboards; Support system validation and upgrade activities; Generate reports and KPIs for study teams; Conduct user training and create job aids; Monitor TMF health and inspection readiness; Execute data loads and quality reviews
Seniority
Mid-level, hands-on IC