Sr External Data Specialist

Overview

The Senior External Data Specialist manages processing of external and/or local lab data across the clinical trial lifecycle. The role provides SME support on external data handling to internal teams and external stakeholders while ensuring data integrity and compliance.

What you'll do

• Act as primary study contact and SME/liaison for external data and local lab processing.
• Communicate local lab data and validation issues to the Clinical Data Manager/study team/Manager, External Data.
• Perform QC and entry for lab normal ranges to ensure accurate, compliant documentation.
• Review study protocols and local lab/external data eCRF design and recommend best approaches.
• Conduct QC for external data test transfers for acceptance and maintain related logs.
• Review external vendor/local data listings and issue queries or communicate data issues.

What you'll need

• 5+ years of experience (or equivalent education and experience) to perform key responsibilities.
• Understanding of ICH/GCP guidelines and 21 CFR Part 11.
• Basic science/Bachelor of Science degree in a health-related field (or equivalent combination).
• Excellent command of English (written and verbal).
• Knowledge of clinical data management processes and vendor data processing.
• Proficiency with Microsoft Office applications.
• Ability to work independently and manage multiple projects with strong organization.

Details

• Location: Bangalore, Karnataka.