Clinical Data Manager II

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• 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.

🎯 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.