External Data Acquisition Clinical Data Management Senior Manager

Job Summary

A company is looking for an External Data Acquisition Clinical Data Management Senior Manager.

Key Responsibilities:

• Lead and provide strategic insights into protocol development, specifically focusing on external data collection and integration
• Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives
• Ensure that data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting

Required Qualifications, Training, and Education:

• Bachelor's degree in science or a related field
• 3-5+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry
• Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer
• Strong understanding of data management processes, tools, methodologies, and documentation
• Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices