External Data Specialist

Role Overview:

• External Data Specialist processes external and local lab data across the clinical trial lifecycle.
• The role ensures data integrity and consistency for assigned projects using elluminate.

Responsibilities:

• Perform QC of lab normal ranges, external data test transfers, and reconciliation logs.
• Review protocols, eCRF designs, and vendor data to align the clinical database with study requirements.
• Support study start-up, IST activities, and external vendor data transfer agreements.

Qualifications:

• Bachelor of Science in a health-related field or equivalent experience; Medical Laboratory Technology certificate preferred.
• Understanding of ICH/GCP guidelines, 21 CFR Part 11, medical terminology, and clinical data management processes.
• Strong communication, collaboration, and multitasking skills with attention to detail.