Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Clinical Data Analyst I
Job ID R0000044586 Hyderabad, Telangana, IndiaJob 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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