Job Overview:
Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets. Potential to assist in development of project Data Management Plan, including data review guidelines / set-up of the data management systems according to project requirements. Potential to serve as the operational data management leader – as a Lead Data Reviewer, on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets.

Summary of Responsibilities:
- Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
- Run ancillary programs (e.g., diagnostics, special listings,



reconciliation discrepancy listings) used to support the review of clinical trial data.
- Generate, resolve and track queries to address problematic data identified during data review activities.
- Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
- Apply quality control procedures and checks to ensure data quality standards (client and Fortrea) are achieved.
- Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans, Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc.
- Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clin

📌 Sr Clinical Data Specialist (Bengaluru)
🏢 Fortrea
📍 Bengaluru