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.

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).

Benefits

equal employment opportunities to all employees and applicants
without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical systems managementaccess controlconfigurationvalidationlifecycle managementapplication supportsystem enhancementsperformance monitoringdisaster recovery testingdata quality

Soft Skills

leadershipcollaborationcommunicationproblem-solvingtrainingdocumentationuser enablementrelationship management