Job Title
Clinical Data Specialist
Company
Fortrea
Location
Bangalore, India
Employment Type
Full-time
Job Overview
This role focuses on clinical trial data management and quality control. You will be responsible for reviewing clinical study data, identifying inconsistencies, generating queries, and ensuring accurate, high-quality data is maintained throughout clinical trials in compliance with global regulatory standards.
Key Responsibilities
1. Clinical Data Review & Quality Control
Review clinical trial data as per:
Data Management Plans (DMPs)
Data Review Guidelines
Identify missing, incorrect, or inconsistent data
Generate and resolve data queries
Ensure data integrity and accuracy
2. Data Validation & Programming Support
Run data listings, discrepancy reports, and special analyses
Support reconciliation of clinical data
Assist in testing edit checks and database functionality
Create dummy data for system testing (SAS reports, listings, validation)
3. Clinical Database Support
Assist in setup and maintenance of clinical data management systems
Support database design review (eCRF, edit checks, specifications)
Contribute to database lock/unlock activities
4. Study Coordination & Reporting
Generate study status reports for sponsor meetings
Track and report data management progress
Support communication with project team members
5. Documentation & Compliance
Ensure all work follows:
SOPs (Standard Operating Procedures)
GCP (Good Clinical Practice) guidelines
Maintain documentation in eTMF systems
Support regulatory and audit readiness
6. Team Support & Training
Assist in onboarding and training new team members
Collaborate with cross-functional teams
Support study team in data management activities
Required Qualifications
University/College degree in:
Life Sciences
Health Sciences
Information Technology
Or related field
OR certification in allied health profession
Required Experience
3–5 years experience in clinical data management
Experience in clinical trials and therapeutic areas
Knowledge of medical terminology preferred
Required Skills
Technical Skills
Clinical Data Management systems
Data review and query management
Knowledge of edit checks and database specifications
Basic understanding of SAS/reporting tools (preferred)
Microsoft Office tools
Core Competencies
Strong attention to detail
Good analytical and problem-solving ability
Ability to manage deadlines and workload
Strong organizational skills
Data accuracy focus
Soft Skills
Strong communication skills (written & verbal)
Team collaboration
Ability to work in fast-paced environments
Time management
Adaptability to shifting priorities
Work Environment
Office-based or hybrid / home-based option
May require:
Overtime
Weekend work
Flexible shifts
Role Summary (Simple Explanation)
This is a clinical research data-focused role where you will:
Review and clean clinical trial data
Identify and fix data issues
Work with databases used in clinical trials
Support clinical study teams and sponsors
Ensure data meets regulatory quality standards
Key Insight
This is a mid-level Clinical Data Management role (3–5 years experience)
Strong entry pathway into:
Clinical Data Management (CDM)
Clinical Research Operations
Biostatistics support roles
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