Job Overview:
Serve as a member of the project team with primary responsibility for conducting the clinical data review, query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets. Assist in the development of the project Data Management Plan, including data review guidelines /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements.
Summary of Responsibilities:
Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
Demonstrates capability to read and follow study timelines for on-time deliverables.
Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.




Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data.
Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required.
Generate and QCs data listings for internal data review.
May assist or create dummy data to test edit checks and to test database screen design and functionality.
Assist or create dummy data to test SAS reports and data listing.
Demonstrates the ability to review Edit Check Specifications and Database specifications.
Post Data Management documentation and data management related administrative tasks as requested, inc

📌 Clinical Data Specialist (Bengaluru)
🏢 Fortrea
📍 Bengaluru