Clinical Technology Manager, IT
About The Position
The Clinical Technology, IT is the accountable owner for the strategy, delivery, and operational integrity of information systems supporting 4DMT’s Clinical Research and Development organization. This role ensures clinical systems are fit for purpose, inspection-ready, and maintained in a validated state, while advancing technology solutions that enable efficient, compliant clinical execution. The position serves as the primary liaison between Clinical R&D, Data Management, IT, and external vendors, driving alignment, governance, and disciplined system ownership across the full lifecycle—from design and implementation through operation and retirement.
Requirements
- 8–12+ years of experience implementing and operating technology solutions supporting clinical research and development.
- Proven experience across the CSV lifecycle, including validation, production deployment, support, and decommissioning.
- Strong working 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 a related discipline (or equivalent experience).
Nice To Haves
- Collaboration with Clinical Data Management and Biometrics teams.
- Experience with Medidata Rave, SAS (Grid, Viya, 9.4), Spotfire, and Veeva TMF and RIM.
- Experience operating systems in Google Cloud environments.
- Strong vendor management and service governance experience.
- Experience with product road mapping, KPIs, and SLAs aligned to clinical priorities.
- Exposure to low-code platforms and applied AI in clinical research.
Responsibilities
- Own and operate clinical systems as system owner, including access control, configuration, validation, and lifecycle management.
- Ensure systems remain compliant with GxP regulations and internal SOPs, preserving data integrity and inspection readiness.
- Lead requirements definition, solution design, and implementation planning with cross-functional stakeholders.
- Provide Level-2 application support and vendor coordination for incident resolution and system enhancements.
- Maintain and continuously improve system documentation, including validation deliverables, SOPs, and operational records.
- Partner with Clinical Data Management to support data quality, flow, and operational needs.
- Execute core system governance activities, including performance monitoring, upgrades, disaster recovery testing, access reviews, and license and vendor management.
- Drive system adoption through training, documentation, and user enablement.
- Support audits and regulatory inspections, including inspection responses, remediation, and CAPA closure.
- Contribute to product roadmaps and release planning, balancing business value, regulatory risk, and technical feasibility.
- Manage and maintain collaborative relationships with core business partners.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
