External Data Specialist (Contract)

Role overview A contract External Data Specialist role supporting clinical trial data management across the full lifecycle of laboratory and vendor data processing. The position ensures data integrity through quality control, reconciliation, and compliance with regulatory standards while collaborating with clinical data management teams and external partners.

Responsibilities - Process external and local laboratory data throughout the clinical trial lifecycle, maintaining data integrity and consistency across assigned projects - Perform quality control of laboratory normal ranges and external data test transfers prior to database entry - Review study protocols and eCRF design during start-up, providing recommendations for optimal data aggregation and capture approaches - Maintain external data reconciliation logs and change logs while verifying normal ranges are properly linked to patient results - Issue queries and communicate data issues to internal and external team members via clinical data analytics platforms - Develop exception listing specifications and visualizations, performing start-up and build activities for local lab and external vendor data

Requirements - Bachelor's degree in a health-related field or equivalent combination of education and experience - Understanding of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology - Basic understanding of medical terminology - Knowledge of clinical data management processes and vendor data processing - Strong organizational skills with ability to manage multiple projects independently - Excellent written and verbal communication skills in English

Nice to have - Medical Laboratory Technology certificate - Experience with local lab normal range population activities - Familiarity with data transfer agreement setup and implementation

Benefits and work setup - Contract position - US pay range of $85,000–$110,000 USD - Remote work recognized through industry workplace awards