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 II
Job ID R0000046546 Hyderabad, Telangana, IndiaJob Summary
We are seeking a Clinical Data Management Associate with 4+ 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 4+ 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.
Location- Hybrid
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs