10 Sep
|
ClinicalDM
|
Bengaluru
10 Sep
ClinicalDM
Bengaluru
We are looking for a detail-oriented Clinical Data Reviewer to support clinical data management activities from study startup through database lock. The ideal candidate will have hands-on experience in study setup, data review, query management, data cleaning, and reconciliation activities.
Experience: Minimum 2 Years
Timmings: 5:30 PM to 1:30 AM IST (US Shift)
Key Responsibilities:
• Support study setup and EDC configuration activities.
• Draft, review, and implement Data Validation Checks (DVCs/DVTs).
• Perform UAT, Unit Testing, and peer review of database configurations and edit checks.
• Conduct ongoing clinical data review and discrepancy management.
• Generate, review, and resolve data queries.
• Perform external data reconciliation with laboratory, safety, ECG, imaging, and other vendor data.
• Prepare data listings, review reports, and study status reports.
• Support database lock and study close-out activities.
• Collaborate with cross-functional teams and external vendors.
• Maintain study documentation and support other CDM activities as required.
Requirements:
• Minimum 2 years of hands-on experience in Clinical Data Management (CDM).
• Experience with study setup, DVC/DVT drafting and review, UAT, Unit Testing, and peer review.
• Experience in live study activities including data review, query management, data cleaning, and reconciliation.
• Understanding of database lock and study close-out processes.
• Experience with EDC platforms such as Zelta, Medidata Rave, Oracle Clinical, or similar systems.
• Proficiency in MS Excel, including pivot tables, lookups, data comparison, and reconciliation.
• Working knowledge of MS Word, PowerPoint, and Outlook.
• Positive understanding of GCP, SOPs, and CDM standards.
• Strong analytical, communication, organizational, and problem-solving skills.
📌 Clinical Data Reviewer (Bengaluru)
🏢 ClinicalDM
📍 Bengaluru