Clinical Data Specialist - (Lab Normal Ranges)

IQVIA; India; Hybrid; INR 700,000 - 1,500,000; Full time

Job summary

IQVIA is seeking a Clinical Data Specialist (Lab Normal Range) to review, interpret, and maintain Laboratory Normal Range data across studies. Hybrid work model with PAN-India scope allows collaboration with Clinical Data Management and Lab Vendors.

This role involves coordinating with study teams and data operations to resolve discrepancies and ensure data quality end-to-end. The role requires 3–6 years of experience, strong experience with Medidata Rave EDC, LNR management, and rigorous data

Qualifications

• Hands on experience reviewing, interpreting, and maintaining Laboratory Normal Range (LNR) documents.
• Experience in LNR data entry, configuration, and validation within CDM systems.
• Strong QC and QC Review skills to ensure data accuracy and compliance.

Responsibilities

• Review, interpret, and maintain Laboratory Normal Range (LNR) documents with high accuracy.
• Enter, configure, and validate LNR data within Clinical Data Management systems.
• Perform QC and QC Review to ensure data accuracy and regulatory compliance.
• Understand laboratory tests, analytes, reference ranges, units, and data standards.
• Support Medidata Rave EDC study database setup and data management activities.
• Identify and resolve LNR and unit discrepancies with stakeholders.
• Collaborate across Clinical Data Management, Laboratory Vendors, and Study Teams.

Skills

Lab Normal Range (LNR) Management

Medidata Rave EDC

Clinical Data Management

LNR QC & Validation

Tools

Medidata Rave EDC

Job description

Role: Clinical Data Specialist (Lab normal range)

Work Experience: 3 to 6 years

Work location: Across PAN India

Work Mode: Hybrid

Must Have Skills: Lab Normal Range (LNR) Management, Medidata Rave EDC, Clinical Data Management, LNR QC & Validation.

Essential Functions :

• Hands on experience reviewing, interpreting, and maintaining Laboratory Normal Range (LNR) documents with a high level of accuracy and attention to detail.


• Proven experience in Lab Normal Range (LNR) data entry, configuration, and validation within Clinical Data Management systems.


• Strong ability to perform Quality Control (QC) and QC Review activities to ensure the accuracy, consistency, and compliance of LNR data.


• Solid understanding of laboratory tests, analytes, reference ranges, units of measure, and laboratory data standards used in clinical trials.


• Experience working with Medidata Rave EDC, including support for study database setup, maintenance, and related data management activities.


• Ability to identify, investigate, and resolve Lab Normal Range and unit-related discrepancies in collaboration with internal and external stakeholders.


• Strong communication and stakeholder management skills with experience working across Clinical Data Management, Laboratory Vendors, Study Teams, and Data Operations groups.


• Demonstrated commitment to data quality, regulatory compliance, and timely delivery of study milestones in a clinical research environment.