Tech Stack

Description

You will own the strategy, delivery, and operational integrity of information systems supporting clinical research and development. You will ensure clinical systems are fit for purpose, inspection-ready, and maintained in a validated state while advancing technology solutions for efficient clinical execution.

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).
• Preferred: Collaboration with Clinical Data Management and Biometrics teams.
• Preferred: Experience with Medidata Rave, SAS (Grid, Viya, 9.4), Spotfire, and Veeva TMF and RIM.
• Preferred: 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.