Clinical IT Quality Control Analyst
Core
Ensure quality, compliance, and validation of technology used in clinical research environments to maintain reliable, audit-ready systems.
Role type
Clinical IT Quality Control Analyst
Builds
Validated computerized systems supporting clinical research and patient outcomes
Domain
Clinical research / Biotechnology / Pharmaceutical / Regulated environments
Required skills
Computerized systems validation, GxP compliance, 21 CFR Part 11, validation lifecycle documentation, risk management, IQ/OQ/PQ protocols, regulatory standards review
Preferred skills
GCP clinical research environment experience, GAMP V, PIC/S, ICH frameworks, EU Annex 11 knowledge
Technologies
GAMP V, PIC/S, ICH, EU Annex 11
Responsibilities
Provide quality and compliance guidance to research operations and IT teams regarding software validation and GxP requirements; Oversee quality activities related to software, processes, and data-integrity validation; Review validation lifecycle documentation including validation assessments and risk-management plans; Ensure validation documentation is complete, accurate, and aligned with SOPs and regulatory requirements; Support quality activities throughout IQ, OQ, and PQ protocol phases; Conduct periodic reviews of system documentation to confirm ongoing compliance; Perform quality reviews of changes affecting validated systems
Seniority
Mid-level, hands-on IC
