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 responsible for clinical data review, query generation/resolution, and reconciliation activities. Support the Data Management Lead in delivering clinical data aligned with client quality specifications, timelines, and productivity targets. May assist in the development of project Data Management Plans and setup of data management systems.
Summary of Responsibilities:
Ensure all assigned projects follow protocols, GCP standards, and SOPs.
Review clinical trial data as per Data Management Plans and raise queries for resolution.
Assist with study design suggestions and timeline inputs when needed.
Run and execute special listings and discrepancy listings to support data review.
Generate, resolve, and track queries for data discrepancies.
Collaborate with project team members for setup, maintenance, and closure of data management tasks.
Generate and quality check (QC) internal data listings.
Create dummy data for testing edit checks, SAS reports, and database functionality.
Review Edit Check Specifications and Database Specifications.
Manage documentation tasks including eTMF maintenance.
Prepare study status reports for Sponsor meetings.
Support database lock/unlock activities.
Train new staff on project-specific data management procedures.
Perform other assigned duties.
Qualifications (Minimum Required):
University/college degree in life sciences, health sciences, IT, or related field, or allied health certification from an accredited institution.
Fluent in English (written and verbal).
Experience (Minimum Required):
3–5 years of relevant experience in data management, including at least one therapeutic area.
Strong time management and adherence to productivity timelines.
Preferred:
Knowledge of medical terminology and scientific background
Effective clinical data management practices
Fortrea SOPs and organizational structure
Skills:
Strong communication and interpersonal skills
Team-oriented with collaborative mindset
Organizational and problem-solving abilities
Ability to work under pressure and manage shifting priorities
Work Environment:
Office and/or home-based
Flexible shifts, including overtime or weekend work as needed
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