Lead Clinical Systems Specialist

ICON πŸŒπŸ’‘πŸ§ͺ

Benefits

Job Description

As a CTMS Business System Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. We are looking for an agile and experienced individual to be responsible for monitoring and maintaining effective business use of the Veeva Vault CTMS (System). As the CTMS Administrator, this role will be responsible for the day-to-day management of Veeva Vault CTMS. This role will support configuration of the platform, steward operational trial data, and partner with cross-functional teams to streamline study start-up through close-out, ensuring the system remains audit-ready, compliant, and an authoritative source of truth for program, study, country, and site information. What you will be doing: Serve as an administrator for Vault CTMS: manage roles/permissions, study/workflow configuration, reference data, and picklists. Monitor performance, schedule and validate Veeva releases (3 x’s per year), and drive enhancements or new module enablement. Support the establishment and enforcement of reporting, procedures and best practices for data within the configuration of the CTMS system. Help define data standards, perform routine data quality checks, and reconcile feeds from eTMF, safety, finance, and data-warehouse tools. Design dashboards/KPIs (enrollment, milestone burn-down, protocol deviations, monitoring visit compliance, etc.) to provide near-real-time insights to study teams and leadership. Support maintenance of validation pack, traceability matrices, and audit trails to meet GxP, ICH-GCP, and 21 CFR Part 11 requirements. Support internal/health-authority inspections by supplying system evidence and responding to findings. Support the development of SOPs, quick-reference guides, and deliver live/recorded training for new functionality or process changes.

About ICON

ICON is the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

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