Clinical Data Analyst I
Primary Location: India, Hyderabad Job ID R0000044586 Category Data Management
About this Role
Job Summary
We are seeking a Clinical Data Management Associate with 2+ years of experience to support clinical trial data review, data cleaning, query management, and vendor data reconciliation activities. The role involves reviewing clinical data listings, resolving data discrepancies, performing CRF freeze and lock activities, coordinating with internal and external stakeholders, conducting User Acceptance Testing (UAT), and maintaining study documentation within Veeva Vault/eTMF. The ideal candidate will have hands-on experience with EDC systems, clinical data review tools, and a strong understanding of clinical research data management processes.
Skillsets
Clinical Data Review and Data Cleaning
Clinical Data Listings Review
Query Management and Discrepancy Resolution
Vendor Data Reconciliation, including Local Lab Review
External Data Review and Reconciliation
CRF Freeze and Lock Activities
User Acceptance Testing (UAT) for Listings, Screens, and Edit Checks
eTMF Documentation and Veeva Vault Management
Clinical Data Workbench Experience
Knowledge of Clinical Trial Data Management Processes
Understanding of ICH-GCP, Regulatory Guidelines, and 21 CFR Part 11
Cross-functional Collaboration and Stakeholder Management
Strong Written and Verbal Communication Skills
Tools & Systems:
EDC: Medidata RAVE (Preferred), Oracle Clinical
Data Review: J-Review, Spotfire
Documentation: Veeva Vault, eTMF
Microsoft Office Suite, Microsoft Project, PowerPoint
Qualification
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.
Experience with Veeva Vault and eTMF documentation is preferred.
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