Job Description

Responsibilities

• Lead clinical data management activities for one or more studies of increasing complexity
• Design and oversee CRF/eCRF implementation and manage vendor coordination for data quality
• Review study protocols and resolve data management queries with site coordinators and investigators
• Track study progress using reports and ensure timelines and quality standards are met
• Train and mentor less experienced colleagues in CDM processes and emerging technologies

Requirements

• Bachelor's degree with six years of experience, or Master's degree with four years of experience
• Clinical data management or data analytics and management experience
• Demonstrated leadership of CDM deliverables and small project teams
• Advanced knowledge of FDA/EMA regulations, NDA requirements, and EDC systems
• Project and risk management skills with budget management capability
• Understanding of CDM impact on product development and cross-functional implications

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