Clinical Data Specialist
Company: Fortrea
Job Location: Bangalore, India
Employment Type: Full-Time
Work Environment: Office / Home-Based
Job Requisition ID: 264354
Job Overview
The Clinical Data Specialist will work as part of the Clinical Data Management project team, with primary responsibility for clinical data review, query generation and resolution, reconciliation, data-quality activities, and project data management support.
The role will support the Data Management Lead in delivering accurate, complete, and high-quality clinical data within client specifications, project timelines, GCP requirements, and productivity targets.
The position may also contribute to the development of Data Management Plans, Data Review Guidelines, Edit Check Specifications, eCRF specifications, and clinical data management system setup.
Key Responsibilities
Clinical Data Review
Review clinical trial data according to Data Management Plans (DMPs) and Data Review Guidelines.
Identify erroneous, missing, incomplete, or inconsistent clinical data.
Raise appropriate queries to resolve data discrepancies.
Generate, resolve, and track queries through completion.
Perform data reconciliation activities.
Run special listings and discrepancy reports to support clinical data review.
Support aggregate data review activities.
Data Management Activities
Support the Data Management Lead with project activities and deliverables.
Assist with the development and maintenance of:
Data Management Plans
Data Review Guidelines
Edit Check Specifications
eCRF Specifications
Support the setup, maintenance, and closure of Data Management activities.
Participate in project meetings and collaborate with other project team members.
Follow study timelines and ensure assigned deliverables are completed on time.
Data Listings & Quality Control
Generate clinical data listings for internal review.
Perform QC of data listings.
Run additional programs and listings required for data review.
Assist with the preparation and testing of SAS reports and data listings.
Review database specifications and Edit Check Specifications.
Database & Edit Check Testing
Create or assist with creation of dummy data for testing.
Test edit checks.
Test database screen design and functionality.
Support testing of SAS reports and data listings.
Identify and communicate issues found during testing.
Documentation & Reporting
Maintain Data Management documentation.
Perform Data Management-related administrative activities.
Maintain eTMF documentation where required.
Prepare study status reports for Sponsor meetings.
Generate reports based on specific Sponsor requirements.
Maintain accurate project records and trackers.
Database Lock / Unlock
Assist with Database Lock and Unlock activities.
Complete assigned activities and documentation associated with database lock.
Ensure project timelines and quality requirements are met.
Training & Team Collaboration
Support training of new team members on project-specific Data Management processes.
Work collaboratively with project team members and peers.
Attend required project meetings.
Maintain effective communication with internal stakeholders.
Demonstrate a constructive and solution-oriented approach to unexpected issues and tight deadlines.
Compliance & Quality
All assigned projects must be conducted in accordance with:
Clinical trial protocols
Good Clinical Practice (GCP)
Fortrea Global Harmonized SOPs
Data Management Plans
Data Review Guidelines
Client-specific requirements
Project timelines and productivity targets
Minimum Qualifications
University/College degree in:
Life Sciences
Health Sciences
Information Technology
Related discipline
Certification in an allied health profession from an appropriate accredited institution may also be considered.
Fluent in English, both written and verbal.
Required Experience
3–5 years of relevant Clinical Data Management experience with increasing responsibility.
Knowledge of at least one or more therapeutic areas.
Knowledge of effective Clinical Data Management practices.
Knowledge of medical terminology is preferred.
Scientific or clinical background is preferred.
Strong time-management skills.
Ability to meet project productivity metrics and deadlines.
Strong oral and written communication.
Good organizational and interpersonal skills.
Ability to work effectively in a team environment.
Strong collaboration skills.
Ability to manage multiple priorities and unexpected events while remaining deadline-focused.
Preferred Qualifications
Familiarity with Fortrea's organizational structure.
Knowledge of Fortrea SOPs and internal processes.
Experience with clinical data management systems.
Experience with data listings, reconciliation, edit checks, and database testing.
Experience with SAS reports/listings would be advantageous.
Core Skills
Clinical Data Management | Clinical Data Review | Query Management | Query Resolution | Data Reconciliation | Data Quality | DMP | Data Review Guidelines | Edit Checks | eCRF | Database Specifications | Data Listings | SAS Reports | Database Testing | Database Lock | Database Unlock | eTMF | GCP | Clinical Trials | Therapeutic Areas | Medical Terminology | Sponsor Reporting
Experience – 1-Line Summary
3–5 years of Clinical Data Management experience with hands-on exposure to clinical data review, query management, reconciliation, data listings, edit-check/database testing, eTMF, and database lock/unlock activities.
Salary Package – Market Estimate
The JD does not disclose an official Fortrea salary range. For a Bangalore-based Clinical Data Specialist with 3–5 years of relevant experience, a reasonable market estimate is approximately ₹6–10 LPA CTC, while candidates with strong CDM tools, EDC, SAS, therapeutic-area, and database-management experience may target approximately ₹8–12 LPA.
Expected market range: ₹6–10 LPA
Strong candidate: ₹8–12 LPA
Potential higher range: ₹12+ LPA for highly relevant/specialized Clinical Data Management experience.
Note: This is a market estimate only and is not an officially confirmed Fortrea compensation range.
Work Environment
Office and/or home-based work environment.
Flexible shifts may be required depending on business requirements.
Overtime and weekend work may occasionally be required.
Candidate should be comfortable working according to project timelines and business needs.
Ideal Candidate Profile
The ideal candidate should have 3–5 years of Clinical Data Management experience with practical knowledge of clinical data review, query management, reconciliation, data listings, edit checks, database testing, SAS reports, eTMF, and database lock/unlock activities.
Candidates with experience in clinical trials, EDC/CDM systems, therapeutic areas, GCP, and Sponsor-facing project activities would be particularly suitable for this position.
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