Clinical Data Analyst I

Role Overview

We are currently seeking an experienced Clinical Data Analyst I based in Hyderabad / Secunderabad, Telangana, India to support our high-volume clinical trials. In this role, you will be instrumental in ensuring data integrity through rigorous review, cleaning, and reconciliation activities.

Key Responsibilities:

• Comprehensive Clinical Data Review & Cleaning: Perform detailed listings reviews on EDC systems such as Medidata RAVE and Oracle Clinical.
• Query Management: Efficiently generate, track, and resolve data discrepancies to ensure database readiness for freeze/lock activities.
• Vendor Reconciliation: Collaborate with local vendors (including Local Lab Review) to reconcile external source data against clinical databases.
• CRF Freeze & Lock Activities: Lead the coordination of final CRF freezing and study lock processes in adherence to timelines.
• UAT Coordination: Conduct User Acceptance Testing for listings, screens, and edit checks prior to deployment.
• Veeva Vault/eTMF Management: Ensure all study documentation is accurately maintained within Veeva Vault/eTMF systems.

Required Skills & Tools:
You will leverage experience with J-Review and Spotfire for data review tasks. Proficiency in Microsoft Office Suite, Project, and PowerPoint is essential.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Minimum 2+ years of hands-on Clinical Data Management experience within a CRO setting (e.g., Parexel).
• In-depth knowledge of ICH-GCP guidelines and regulatory standards including 21 CFR Part 11.