Clinical Data Manager / Senior Clinical Data Manager
Core
Managing high-quality clinical data through review, cleaning, reconciliation, and query management to ensure database lock readiness for a critical diagnostic validation study.
Role type
Senior IC Clinical Data Manager
Builds
Clinical study databases and data specifications for diagnostic development programs
Domain
Diagnostics / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Clinical data management, EDC systems (Medidata Rave), database lock activities, query management, data reconciliation, derived variable specifications, TFL specifications, SAP interpretation
Preferred skills
Oncology studies, IVD experience, R programming, AI tools (Claude Code, Gemini), Clario platform
Technologies
Medidata Rave, Clario, R
Responsibilities
Perform ongoing clinical data cleaning, query management, and discrepancy resolution within EDC systems; Conduct sample-to-clinical data reconciliation; Review data-quality reports and translate findings into queries and resolutions; Support CRF freeze and database lock readiness; Develop Derived Variable specifications and review Table, Figure, and Listing specifications against the Statistical Analysis Plan; Interpret SAP requirements into actionable specification documents (Senior level); Provide limited statistical programming support for derived variables and TFL datasets.
Seniority
Senior, hands-on IC