- 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
- Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines)
- Experience with query management and discrepancy resolution
Core Competencies
Expertise in clinical data management, including data review, discrepancy resolution, and compliance with regulatory requirements. Proficient in using Medidata Rave for managing clinical trial data and ensuring data integrity.
Highest-signal resume keywords
- Clinical Data Management
- Medidata Rave Proficiency
- Data Review Experience
- Regulatory Compliance (GCP, FDA, ICH)
- Query Management
Hard Skills
- Data Review
- Discrepancy Resolution
- Data Cleaning
- Database Lock Activities
- User Access Management
- Audit-Ready Documentation
- System User Training
Soft Skills
- Collaboration
- Problem-Solving
Industry Keywords
- Clinical Trials
- Study Protocols
- Data Management Plans (DMPs)
- Access Requests
- Compliance Checks
Tools & Technologies
- Clinical Data Management Systems
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Senior Clinical Data Manager Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
