Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager ensuring accurate, compliant clinical trial data for pharmaceutical studies. Managing data reviews, discrepancies, database locks, and clinical system access.
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 Clinical Operations, Biostatistics, Programming, and Medical Monitoring 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 such as Medidata Rave
- Process access requests, modifications, and terminations according to established procedures
- Ensure appropriate role-based access and system permissions
- 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
Requirements:
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience)
- 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
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