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.
- Good understanding of GCP, SOPs, and CDM standards.
- Robust analytical, communication, organizational, and problem-solving skills.

📌 Clinical Data Reviewer (Bengaluru)
🏢 ClinicalDM
📍 Bengaluru