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A global research consulting group providing 360° support & services across all facets of clinical outcomes research.
Clinical Data Manager II
Location
United Kingdom
Posted
46 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Data Manager II
Clinical Outcomes Solutions
• 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 (Clinical Operations, Biostatistics, Programming, Medical Monitoring) 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.
Job Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
- Minimum of 2 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).
- Cloud Administration module experience is preferred.
- 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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