Clinical Trial Management System (CTMS) Manager

Smartedge’s Client is looking for an individual to help with their

Clinical Trial Management System (CTMS) Manager @ Remote (Romania)

Key area:

The CTMS Manager is responsible for the accurate setup, maintenance, and oversight of clinical trial data within the Clinical Trial Management System across the full study lifecycle. This role ensures CTMS data quality, milestone accuracy, and operational reporting to support study execution, oversight, and inspection readiness.

Key Responsibilities Manage CTMS setup and maintenance for studies, countries, and sites across Phase 1–4 and NIS trials Ensure ongoing CTMS data accuracy, completeness, and timeliness, resolving discrepancies and coordinating with study teams and CROs as needed Track and maintain study milestones, site status, enrollment, and operational progress within CTMS Act as CTMS subject matter expert for study teams, vendors, and audits/inspections Produce CTMS reports and dashboards to support operational oversight and decision-making Support system changes, upgrades, and user adoption in coordination with business and IT stakeholders Required Experience & Skills Strong understanding of the clinical trial lifecycle and clinical operations processes Hands-on experience with CTMS platforms (e.g., Oracle/Siebel CTMS, Medidata, Veeva, or similar) Experience supporting global, multi-site clinical trials Ability to manage multiple studies concurrently and work across cross-functional teams Strong attention to detail, data quality mindset, and communication skills Bachelor’s degree in life sciences or a related field (advanced degree a plus) Owns CTMS data accuracy, study tracking, and operational reporting to support compliant and efficient clinical trial execution.

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