Manager, Computer System Validation (CSV)

Alimentiv(5 days ago)

Toronto, OntarioOnsiteFull TimeSenior$118,453 - $160,817 (estimated)Quality Assurance

About this role

The Manager/Senior Manager, Computerized System Validation will lead the transformation of CSV practices at a contract research organization, ensuring computerized systems that support clinical research meet global regulatory expectations. The role centers on applying FDA, EMA, GCP, and ICH requirements pragmatically to both commercial and custom software to enable compliant, agile delivery. This leader collaborates across Technology, Product, Quality, and operations to drive practical, risk-based approaches and continuous improvement.

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Required Skills

Computerized System Validation
Risk Assessment
Validation Planning
Test Execution
Traceability Matrix
Regulatory Compliance
Data Integrity
GxP
Vendor Management
Audit Support

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About Alimentiv

alimentiv.com

Alimentiv is a gastrointestinal-focused clinical research organization (CRO) that accelerates GI clinical trials through a specialized site network and integrated trial services. They provide end-to-end support including site operations, medical imaging, and biomarker discovery to help sponsors design, conduct, and analyze GI studies. Alimentiv positions itself as a partner for biotech and pharma teams needing disease-area expertise and integrated diagnostics to improve trial efficiency and decision-making.