Senior Clinical Data Manager

Overview

As Senior Clinical Data Manager, you will lead data review to ensure accuracy, completeness, and consistency of clinical trial data in alignment with the study protocol and DMP. You will collaborate with cross-functional teams to support data cleaning and prepare data for interim and final analyses, while ensuring regulatory compliance. You will manage user access and maintain audit-ready documentation, contributing to data readiness for database locks. This remote, full-time role emphasizes data integrity, system proficiency, and governance within a global clinical program.

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

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field
• Minimum of 4 years of clinical data management experience
• Demonstrated hands-on data review experience in clinical trials
• Proficiency in Medidata Rave (build knowledge a plus, but not required)
• Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines)
• Experience with query management and discrepancy resolution

• Cross-functional collaboration
• Attention to detail
• Problem solving and issue resolution
• Medidata Rave
• clinical data management processes
• query management

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