Manager, Computer System Validation (CSV)

Alimentiv(5 days ago)

Baltimore, MarylandOnsiteFull TimeManager$113,518 - $150,415 (estimated)Quality Assurance

About this role

A Manager/Senior Manager, Computerized System Validation at a contract research organization leads transformation of CSV practices to ensure computerized systems supporting clinical research meet global regulatory expectations. The role focuses on applying FDA, EMA, GCP, and ICH standards pragmatically to both off-the-shelf and custom software while enabling agile delivery. It partners with Technology, Product, Quality, and operations teams to drive continuous improvement in technology and clinical research operations.

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Required Skills

Computerized System Validation
Regulatory Compliance
Risk Assessment
GxP
GAMP5
Data Integrity
Project Management
Vendor Management
Audit Support
Team Leadership

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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.