eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

OVERVIEW

The Senior External Data Specialist is responsible for managing the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The Senior External Data Specialist will provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, imaging, PK, PD, eCOA, ePRO, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. The Senior External Data Specialist works to ensure departmental SOPs, guidelines,



regulatory and global standards are followed to maintain data integrity and ensure consistency across all assigned projects.

This position reports to the Manager, External Data.

KEY TASKS & RESPONSIBILITIES

In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities:
- Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders.
- Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues.
- Communicate to vendors and client issues involving external data transfers, data point issues and validation issues.
- Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate.
- Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and

📌 Sr External Data Specialist (Bengaluru)
🏢 eClinical Solutions
📍 Bengaluru