Senior Clinical Data Manager

Overview

As Senior Clinical Data Manager, you ensure high-quality data across assigned studies. You drive ongoing data reviews to verify accuracy, completeness, and consistency with protocols and the data management plan. You collaborate with cross-functional teams to support data cleaning, and you lead activities toward timely database lock and analysis readiness. You work with Medidata Rave and manage access control to keep systems secure and audit-ready. This role supports regulatory compliance and data integrity across clinical trials.

Responsibilities

• Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency
• Identify, investigate, and resolve data discrepancies through query management
• Conduct manual and system-driven data reviews in accordance with study protocols and DMPs
• Collaborate with cross-functional teams to support data cleaning activities
• Participate in database lock activities and ensure data readiness for interim and final analyses
• Maintain study documentation in compliance with regulatory requirements and internal SOPs
• Manage and maintain user access within clinical data management systems (e.g., Medidata Rave)
• Process access requests, modifications, and terminations in accordance with established procedures
• Ensure appropriate role-based access and system permissions are assigned
• Maintain audit-ready documentation related to user access activities
• Support periodic access reviews and compliance checks
• Assist with system user training and troubleshooting as needed

Key requirements

• Minimum of four years of clinical data management experience
• Hands-on data review experience in clinical trials
• Proficiency in Medidata Rave (build knowledge a plus, not required)
• Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH)
• Experience with query management and discrepancy resolution

• collaboration with cross-functional teams
• attention to detail
• regulatory compliance mindset
• Medidata Rave
• query management
• data review

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