Clinical Data Specialist

6 days ago


Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time
Job Title: Clinical Data Specialist

Fortrea Development India Pvt Ltd is seeking a highly motivated and detail-oriented Clinical Data Specialist to join our team. As a Clinical Data Specialist, you will play a critical role in ensuring the accuracy and integrity of clinical trial data.

Key Responsibilities:
  • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
  • Demonstrate 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, including maintenance of eTMF as required.
  • Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request.
  • Assist with the completion of Database Lock and Unlock activities.
  • Supports the training of new staff on project specific Data Management processes. Performs any other duties as assigned


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