Clinical Monitoring Analyst
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• Support the Centralized Monitoring Lead in developing a fit-for-purpose CM strategy
• Setup and program QTL, KRI, and Data Quality Assessments per the CMP
• Refresh the Centralized Monitoring Platform at defined frequencies
• Create and maintain CM platform specifications documents (eTMF filing)
• Review study protocol to inform CM activities
• Understand study data sources, transfer specs and data structure
• Peer-review CM platform setup performed by colleagues Responsabilidades
• At least 3 years in pharmaceutical Ru0026D or related field with centralized monitoring, data management, or biostatistics
• 2-3 years SAS experience including macro language
• Knowledge or experience with Cluepoints
• Ability to work autonomously and engage with stakeholders
• Understanding of basic statistical concepts and interpretation of outputs
• Ability to handle confidential information and work with limited supervision
• Experience with relational databases, preferably CDM and EDC systems
• Strong verbal and written English communications Requisitos principales
• remote work
• home-based flexibility
• collaborative tools and global team
• autonomy in role
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