13 Aug
|
1060 Parexel International
|
Hyderabad
13 Aug
1060 Parexel International
Hyderabad
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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
- Robust Written and Verbal Communication Skills
Tools & Systems:
- EDC: Medidata RAVE (Preferred), Oracle Clinical
- Data Review: J-Review, Spotfire
- Documentation: Veeva Vault, eTMF
- Mi
📌 Clinical Data Analyst I (Hyderabad)
🏢 1060 Parexel International
📍 Hyderabad