Job Summary

A contract research organization is seeking a Remote Lead External Data Specialist.

Core Responsibilities Include:

• Generating, resolving and tracking queries to address problematic data identified during data review activities
• Running ancillary programs used to support the review of clinical trial data
• Reviewing clinical trial data in accordance with Data Management Plans and applicable standardized data management processes

Required Skills:

• Knowledge of effective clinical data management practices
• Knowledge of ICH Guidelines and GCP
• Knowledge of drug development process
• Demonstrated time management skill and ability to adhere to project productivity metrics and timelines
• Minimum 4 years relevant work experience with increasing responsibility in data management with knowledge of 2 or more therapeutic areas