Manager, Computer System Validation (CSV)

Alimentiv

2 months ago

3.6 on Glassdoor

Baltimore, Maryland

Onsite

Full Time

Manager

4 applicants

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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.

Skills

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.

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