Fortrea is inviting applications for the position of Clinical Data Specialist in Bangalore, India. This opportunity is ideal for experienced Clinical Data Management (CDM) professionals with 3โ5 years of experience who are passionate about ensuring high-quality clinical trial data, database integrity, query management, reconciliation, and database lock activities.
If you have experience in Clinical Data Review, Query Management, eCRF, Edit Checks, Reconciliation, SAS Listings, and Database Lock, this Fortrea Clinical Data Specialist job could be an excellent career opportunity.
Job Overview
As a Clinical Data Specialist, you will work closely with the Data Management Lead and cross-functional clinical teams to ensure accurate, complete, and high-quality clinical trial data. You will support data cleaning, discrepancy management, database setup, sponsor deliverables, reconciliation activities, and database lock while maintaining compliance with ICH-GCP, SOPs, and regulatory standards.
Job Details
| Details | Information |
|---|---|
| Position | Clinical Data Specialist |
| Company | Fortrea |
| Job Type | Full-Time |
| Location | Bangalore, India |
| Experience | 3โ5 Years |
| Qualification | Life Sciences, Health Sciences, Information Technology or Allied Health |
| Department | Clinical Data Management |
| Job ID | 263907 |
Key Responsibilities
The selected candidate will:
- Review clinical trial data according to Data Management Plans.
- Perform clinical data review and discrepancy management.
- Generate, track, and resolve clinical data queries.
- Execute reconciliation listings and special data listings.
- Review Edit Check Specifications and Database Specifications.
- Assist in eCRF specification development.
- Support Data Management Plan preparation.
- Perform quality control (QC) of clinical data listings.
- Create dummy data for edit check testing.
- Test database functionality and SAS reports.
- Maintain Data Management documentation.
- Support eTMF maintenance.
- Generate sponsor status reports.
- Assist in Database Lock and Unlock activities.
- Collaborate with cross-functional clinical project teams.
- Support onboarding and training of new team members.
- Ensure compliance with ICH-GCP, SOPs, and protocol requirements.
Required Qualifications
Applicants should possess:
- University degree in:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Biotechnology
- Microbiology
- Biochemistry
- Clinical Research
- Health Sciences
- Information Technology
- Allied Health Sciences
- Excellent written and verbal English communication.
- Strong understanding of Clinical Data Management principles.
Required Experience
Candidates should have:
- 3โ5 years of Clinical Data Management experience.
- Experience with:
- Clinical Data Review
- Query Management
- Data Cleaning
- Reconciliation
- eCRF Review
- Edit Checks
- Database Lock
- Clinical Trial Data Validation
- Knowledge of medical terminology.
- Understanding of ICH-GCP guidelines.
- Strong analytical and problem-solving skills.
- Ability to manage multiple project timelines.
Preferred Skills
- Clinical Data Review Guidelines
- Data Management Plans (DMP)
- Database Specifications
- SAS Listings
- Edit Check Testing
- Clinical Trial Reconciliation
- eTMF Documentation
- Sponsor Communication
- Team Collaboration
- Time Management
- Clinical Research Operations
Why Join Fortrea?
Fortrea offers professionals the opportunity to work on global clinical trials with advanced Clinical Data Management processes.
Benefits include:
- Global clinical research exposure
- International sponsor projects
- Hybrid/Office work environment
- Career growth opportunities
- Collaborative global teams
- Learning across therapeutic areas
- Flexible shift opportunities
- Professional development programs
How to Apply
