Role Overview

We are seeking a Systems Analyst to support the Elluminate clinical data platform, focusing on system validation, data integrations, and operational support within a GxP-regulated clinical environment. The role will collaborate with Clinical Data Management, Clinical Systems, IT, and Data Engineering teams to ensure reliable ingestion, validation, and integration of clinical trial data.

Key Responsibilities

• Support operational activities related to the Elluminate clinical data platform.
• Monitor and support data ingestion workflows integrating data from systems such as EDC (Medidata Rave), eCOA platforms, safety systems (e.g., Argus), and laboratory vendors.
• Collaborate with Clinical Systems, Clinical Data Management, IT, and Data Engineering teams to ensure reliable integration of clinical trial data into the platform.
• Support Computer System Validation (CSV) activities for the Elluminate platform and associated integrations in compliance with GxP requirements.
• Assist in the execution and documentation of IQ/OQ/PQ validation activities, including preparation of validation strategy, test scripts, and validation documentation.
• Participate in validation testing related to system integrations, data ingestion workflows, and platform updates.
• Monitor platform workflows and assist in troubleshooting integration or system operation issues.
• Maintain documentation for system configurations, validation artifacts, and integration workflows.
• Support change control activities to ensure system updates follow established validation and compliance procedures.
• Collaborate with cross-functional teams to support continuous improvement of platform processes and operational readiness.

Required Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or related field.
• 4+ years of experience supporting clinical trial systems or clinical data platforms.
• Hands-on experience with Computer System Validation (CSV) in a GxP-regulated environment.
• Familiarity with IQ/OQ/PQ validation methodologies, validation documentation, and testing practices.
• Experience working with clinical data systems such as Medidata Rave, safety systems, laboratory systems, or vendor platforms.
• Understanding of clinical trial data workflows and system integrations across clinical development systems.
• Strong analytical, troubleshooting, and cross-functional collaboration skills.
• Working knowledge of SQL or data querying tools for validation or troubleshooting activities.