Job Title: Clinical Data Specialist (EDS)
Location: Bangalore
Category: Data Management & Data Science
Job ID: 25217
Job Overview
Serve as a member of the project team with primary responsibility for conducting clinical data review, query generation/resolution, and reconciliation activities. Support the Data Management Lead in delivering clinical data according to client specifications, timelines, and productivity targets. May assist in developing the Data Management Plan (DMP), data review guidelines, edit check specifications, and electronic Case Report Form (eCRF) specifications. May contribute to data management system setup.
Key Responsibilities
Ensure adherence to protocols, global SOPs, and GCP standards.
Follow study timelines for timely deliverables.
Assist in study design or suggest changes to timelines when necessary.
Review clinical trial data and raise queries per DMP and review guidelines.
Execute special listings and reconciliation discrepancy listings.
Generate, resolve, and track queries for problematic data.
Support setup, maintenance, and closure of Data Management aspects.
Generate and QC internal data review listings.
Create and test dummy data for edit checks and database design.
Review Edit Check Specifications and Database Specifications.
Post documentation and maintain eTMF as needed.
Run study status reports for sponsor meetings and special requests.
Assist with Database Lock/Unlock activities.
Support training of new staff on project-specific processes.
Perform other duties as assigned.
Minimum Qualifications
Degree in life sciences, health sciences, IT, or related fields, or certification in allied health professions.
Fluent in English (written and verbal).
Experience Required
3 to 5 years of relevant data management experience.
Familiarity with therapeutic areas and clinical data management practices.
Knowledge of medical terminology and scientific background (preferred).
Time management and adherence to productivity/timeline metrics.
Good oral/written communication and organizational skills.
Ability to work in teams and collaborate effectively.
Constructive problem-solving skills under pressure.
Preferred Qualifications
Knowledge of Fortrea and its organizational structure.
Familiarity with Fortrea SOPs.
Work Environment
Office or home-based setup.
Overtime/weekend work may be required.
Flexibility in shift timings as per business needs.
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