Clinical Data Analyst I

Overview

Support clinical trial data review, data cleaning, query management, vendor data reconciliation, and clinical data management activities as a Clinical Data Analyst I.

What you'll do

• Review clinical data listings.
• Clean clinical data.
• Manage queries and resolve data discrepancies.
• Reconcile vendor data, including local lab data.
• Review and reconcile external data.
• Perform CRF freeze and lock activities.
• Conduct User Acceptance Testing (UAT) for listings, screens, and edit checks.
• Coordinate with internal and external stakeholders.
• Maintain study documentation within Veeva Vault/eTMF.

What you'll need

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline.
• Minimum 2+ years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.
• Hands-on experience with EDC systems, preferably Medidata RAVE and Oracle Clinical.
• Experience in data review, query management, vendor reconciliation, and database lock activities.
• Working knowledge of clinical research regulations, GCP guidelines, and clinical trial processes.
• Knowledge of Clinical Trial Data Management Processes.
• Understanding of ICH-GCP, Regulatory Guidelines, and 21 CFR Part 11.
• Strong written and verbal communication skills.
• Cross-functional collaboration and stakeholder management skills.
• Clinical Data Workbench experience.
• Experience with clinical data review tools, including J-Review and Spotfire.
• Experience with EDC systems.
• Experience with Microsoft Office Suite, Microsoft Project, and PowerPoint.

Nice to have

• Experience with Medidata RAVE.
• Experience with Veeva Vault and eTMF documentation.

Details

• Location: Hyderabad, India.