Clinical Data Analyst II
- Posted 7 days ago
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Job Description
Job 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
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
- EDC: Medidata RAVE (Preferred), Oracle Clinical
- Data Review: J-Review, Spotfire
- Documentation: Veeva Vault, eTMF
- Microsoft Office Suite, Microsoft Project, PowerPoint
- 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.
More Info
Key Skills
Clinical Data Listings Review
Knowledge of Clinical Trial Data Management Processes
eTMF Documentation and Veeva Vault Management
User Acceptance Testing UAT for Listings Screens and Edit Checks
Query Management and Discrepancy Resolution
Clinical Data Workbench Experience
CRF Freeze and Lock Activities
Vendor Data Reconciliation including Local Lab Review
External Data Review and Reconciliation
Understanding of ICH-GCP Regulatory Guidelines and 21 CFR Part 11
Clinical Data Review and Data Cleaning
About Company