Quality Review Specialist
Core
Performing periodic TMF Quality Reviews for assigned clinical studies to ensure documentation completeness and audit readiness.
Role type
Quality Review Specialist (Clinical Operations)
Builds
Audit-ready Trial Master Files (TMF) for the Precision portfolio
Domain
Clinical Research / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
TMF management, eTMF systems, FDA/ICH/GCP regulations, Microsoft Office suite, issue escalation
Preferred skills
Training needs identification, risk assessment, independent planning
Technologies
eTMF systems, Microsoft Office (Outlook, Word, Excel, PowerPoint)
Responsibilities
Perform periodic TMF Quality Reviews, generate and file review documentation, monitor TMF updates for sites/countries/contacts, escalate document processing issues and missing files, identify training needs, escalate high-risk studies
Seniority
Mid-level, hands-on IC
