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4DMTEngineering
Clinical Technology Manager IT
Remote (US)$110,000 - $150,000Posted today
The Clinical Technology, IT professional is responsible for the strategy, delivery, and operational integrity of information systems supporting 4DMT’s Clinical Research and Development organization. This role ensures clinical systems are compliant, validated, and enable efficient clinical execution.
Location: Remote (US)
Salary: $110,000 - $150,000
Responsibilities
- Own and operate clinical systems including access control, configuration, validation, and lifecycle management.
- Ensure systems remain compliant with GxP regulations and internal SOPs.
- Lead requirements definition, solution design, and implementation planning.
- Provide Level-2 application support and vendor coordination.
- Maintain and improve system documentation, validation deliverables, SOPs, and operational records.
- Partner with Clinical Data Management to support data quality and operational needs.
- Execute system governance activities including performance monitoring, upgrades, disaster recovery testing, access reviews, and vendor management.
- Drive system adoption through training, documentation, and user enablement.
- Support audits and regulatory inspections, including inspection responses and CAPA closure.
- Contribute to product roadmaps and release planning.
- Manage and maintain relationships with core business partners.
Requirements
- 8–12+ years of experience supporting clinical research and development technology solutions.
- Proven experience across the CSV lifecycle.
- Strong knowledge of FDA and EMA regulations including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR.
- Broad technical fluency across applications, infrastructure, cloud platforms, integrations, and operations.
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related discipline.
Location
Remote (US)
Salary
$110,000 - $150,000
Category
EngineeringCompany
4DMTSource
himalayas
Posted
today
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