Data Validation and Support Specialist
Core
Provide IT and application support for scientific applications and perform Computer Systems Validation (CSV) activities, including spreadsheet validation, to ensure compliance with regulatory guidelines in a clinical research environment.
Role type
IT Support & Computer Systems Validation Specialist
Builds
Validated scientific software systems, spreadsheets, and IT infrastructure for clinical trials and preclinical studies
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Required skills
Computer Systems Validation (CSV), Spreadsheet validation (Excel), Technical writing, Root cause analysis, Regulatory compliance (GxP, 21 CFR Part 11), System lifecycle management, Incident resolution, Version control
Preferred skills
Excel macros/VBA, LIMS experience, Document Management Systems, Scientific software experience
Technologies
Microsoft Excel, Windows Server, Desktop OS, LIMS, Document Management Systems
Responsibilities
Create and review validation documents (test plans, IQ/OQ/PQ, UAT), perform functional risk assessments, investigate hardware/software problems, support system upgrades and configuration, maintain validation SOPs, resolve user incidents
Seniority
Mid-level, hands-on IC