Clinical Data Specialist
Company: Fortrea
Job Title: Clinical Data Specialist
Location: Bangalore, India
Employment Type: Full-Time
Job Requisition ID: 262862
Application Deadline: June 30, 2026
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) that partners with pharmaceutical, biotechnology, and medical device companies to accelerate clinical development and improve patient outcomes. Through innovative clinical solutions, advanced technology platforms, and scientific expertise, Fortrea supports clinical trials across multiple therapeutic areas worldwide.
Position Summary
The Clinical Data Specialist plays a critical role in the Clinical Data Management (CDM) function by ensuring the accuracy, completeness, consistency, and integrity of clinical trial data. Working closely with Data Management Leads and cross-functional study teams, the specialist performs data review, query management, reconciliation activities, and database support tasks to ensure high-quality clinical data delivery in compliance with regulatory requirements and project timelines.
The role requires strong analytical skills, attention to detail, and a solid understanding of clinical trial processes, data management practices, and electronic data capture systems.
Key Responsibilities
Clinical Data Review & Query Management
Review clinical trial data according to approved Data Management Plans (DMPs) and Data Review Guidelines.
Identify missing, inconsistent, incomplete, or erroneous clinical data.
Generate, manage, and resolve data queries with investigative sites and study teams.
Monitor query aging and ensure timely resolution of outstanding issues.
Perform ongoing data cleaning activities to maintain database quality.
Data Reconciliation & Validation
Execute reconciliation activities between various clinical systems and datasets.
Review discrepancy reports and reconciliation listings.
Run and analyze:
Data listings
Reconciliation reports
Special data review reports
Study-specific review outputs
Support identification and resolution of data discrepancies.
Database Testing & Validation
Review Edit Check Specifications and Database Specifications.
Create and utilize dummy/test data for:
Edit Check Validation
eCRF Testing
Database Functionality Testing
SAS Report Validation
Data Listing Verification
Support User Acceptance Testing (UAT) activities for clinical databases.
Clinical Data Management Support
Assist in developing and maintaining:
Data Management Plans (DMPs)
Data Review Guidelines
Edit Check Specifications
eCRF Specifications
Support study startup, maintenance, and closeout activities.
Assist with database lock and unlock procedures.
Contribute to data management system setup according to study requirements.
Documentation & Compliance
Maintain clinical data management documentation in compliance with:
Good Clinical Practice (GCP)
Standard Operating Procedures (SOPs)
Regulatory requirements
Support maintenance of Trial Master File (TMF/eTMF) documentation.
Ensure proper documentation of all data management activities.
Study Reporting & Sponsor Support
Generate study status reports and project metrics.
Support sponsor meetings through preparation of data review outputs and reports.
Respond to sponsor requests related to data review activities.
Assist Data Management Leads with study progress tracking and reporting.
Team Collaboration & Training
Collaborate with:
Clinical Data Managers
Clinical Operations Teams
Biostatistics Teams
Statistical Programmers
Medical Reviewers
Sponsors and Clients
Participate in project meetings and study reviews.
Support onboarding and training of new team members on project-specific processes.
Educational Qualifications
Required
Bachelor's Degree in:
Life Sciences
Pharmacy (B.Pharm)
Health Sciences
Biotechnology
Biological Sciences
Information Technology
Clinical Research
Related Scientific Disciplines
OR
Certification in an allied health profession from an accredited institution.
Experience Requirements
Required
3–5 years of experience in Clinical Data Management (CDM).
Experience reviewing and cleaning clinical trial data.
Experience with query management and data reconciliation activities.
Exposure to at least one therapeutic area in clinical research.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Japan | Saitama |Tokyo :
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