Specialist Local Lab Delivery

Overview

Ensure laboratory data used in clinical studies is accurate, consistent, and ready when study teams need it, by managing local laboratory reference ranges and supporting metadata throughout the study lifecycle.

What you'll do

• Review and track local laboratory reference range documents to ensure they are complete, current, and available for study activities.
• Maintain accurate laboratory data and metadata, including tests, reference ranges, units, conversion factors, synonyms, and laboratory details.
• Configure and update local laboratory information to support study start-up, ongoing delivery, and database lock.
• Investigate and resolve laboratory data discrepancies, escalating risks and quality concerns when appropriate.
• Partner with Clinical Data Management, Clinical Operations, study teams, and external providers to deliver activities on time.
• Assess and implement updates when laboratories, reference ranges, or supporting information change during a study.
• Maintain clear, inspection-ready documentation and audit trails in line with quality and regulatory expectations.
• Improve processes through metadata standardization, automation, and technology-enabled ways of working.

What you'll need

• A bachelor's degree in science, health, data management, mathematics, computing, or a related field.
• At least 2 years of Clinical Data Management experience, including hands-on experience supporting local laboratory delivery in biotechnology, pharmaceuticals, a CRO, or healthcare.
• Experience managing local laboratory reference ranges and metadata, including analytes, units, conversion factors, test synonyms, and laboratory documentation.
• Ability to review source documents, identify data quality issues, investigate discrepancies, and deliver accurate work within study timelines.
• Knowledge of clinical trial processes, data quality expectations, GxP requirements, and inspection readiness.
• Strong analytical, organizational, communication, and cross-functional collaboration skills.
• Experience with laboratory administration or clinical data systems and the validation or testing of related technologies.

Nice to have

• Experience contributing to metadata standardization, process improvement, automation, or AI-enabled workflows.

Details

• Location: Hyderabad.
• Many roles are required to be performed on-site; confirm on-site expectations with the recruiter and hiring manager.