External Data Management Senior Specialist
Core
Leads trial-level external data strategy, delivery, and quality oversight for clinical trials, ensuring data readiness for CDM review and database lock.
Role type
Senior IC Clinical Data Management Specialist (External Data)
Builds
External data specifications, transfer logs, and audit-ready data feeds for clinical trials.
Domain
Clinical Trials / Healthcare / Data Management
Required skills
Clinical trial operations, External data management, EDC platforms, Data specifications authoring, Data reconciliation, Vendor management, Regulatory compliance (ICH-GCP), Defect triage, Metrics analysis, Documentation for audits
Preferred skills
Nursing/Pharmacy/Life Sciences degree, Programming for edit checks, Service provider forum leadership
Technologies
EDC platforms, eCOA, eTMF, IT systems for data integration
Responsibilities
Develop and maintain external data specifications compliant with standards; Oversee external data file loading and resolve data load issues; Support CDM Trial Lead in data quality oversight and risk identification; Lead service provider management including KPIs, SLAs, and performance metrics; Mentor junior analysts on tools and processes; Ensure compliance with SOPs and ICH-GCP; Prepare documentation for audits and inspections.
Seniority
Senior, hands-on IC
