Senior External Data Specialist

About the role

eClinical Solutions is seeking a Senior External Data Specialist to manage the processing of external and local laboratory data throughout the clinical trial lifecycle. The role serves as the subject‑matter expert for external data sources, ensuring high‑quality data and compliance with SOPs, regulatory standards, and global guidelines.

Key responsibilities

• Act as primary contact and liaison for external data and local lab processing on assigned studies.
• Perform quality control of laboratory normal ranges and external data test transfers to ensure ICH/GCP compliance.
• Review study protocols, eCRF designs, and vendor data to provide recommendations for data aggregation and capture.
• Drive set‑up and implementation of external vendor data transfer agreements, specifications, and exception listings.
• Support cross‑functional teams with data trending, KPI reporting, and process improvement initiatives.

Required profile

• Bachelor’s degree in a health‑related science; Medical Laboratory Technology certificate preferred.
• 5+ years of experience in CRO or pharmaceutical environments, with strong knowledge of ICH/GCP, 21 CFR Part 11, and clinical trial methodology.
• Proven ability to maintain data confidentiality and work independently on multiple projects.

Required skills

• Proficiency in Microsoft Office applications.
• Knowledge of Clinical Data Management Systems and Electronic Data Capture (EDC) platforms.
• Accurate keyboarding and general computer literacy.
• Experience with AI/ML and advanced analytics for real‑time data monitoring.