Fortrea, a leading global contract research organization (CRO), is hiring for Records Management Assistant – TMF and Clinical Data Specialist roles in Bangalore. If you have experience in clinical data management, trial master files, or regulatory documentation, this is a great opportunity to advance your career in the pharmaceutical and clinical research industry.
1. Records Management Assistant – TMF (Trial Master File)
Job ID: 252160
Last Date to Apply: May 27, 2025 (3 days left)
Job Description:
The Records Management Assistant will maintain paper and electronic documents for the electronic Trial Master File (eTMF) in compliance with regulatory and legal guidelines.
Key Responsibilities:
- Store, retrieve, and archive documents securely.
- Index and manage newly received paper/electronic documents.
- Ensure eTMF compliance with Good Clinical Practices (GCP).
- Perform Audit Ready Checks and quality reviews.
- Assist in migrating paper documents to eTMF systems.
- Maintain document security and quick retrieval processes.
- Support training and audits related to records management.
Qualifications:
- Experience in document management, eTMF, or clinical trial records.
- Knowledge of GCP, regulatory guidelines, and data security.
- Strong organizational and detail-oriented skills.
2. Clinical Data Specialist
Job ID: 251797
Last Date to Apply: May 30, 2025 (6 days left)
Job Description:
The Clinical Data Specialist will support data review, query resolution, and database management for clinical trials.
Key Responsibilities:
- Review clinical trial data per Data Management Plans (DMP).
- Generate and resolve data queries to ensure accuracy.
- Assist in database setup, testing, and validation.
- Support database lock/unlock activities.
- Prepare reports for sponsor meetings.
- Maintain eTMF documentation and compliance.
Qualifications:
- 3-5 years in clinical data management.
- Knowledge of medical terminology, GCP, and clinical databases.
- Strong analytical and communication skills.
- Degree in life sciences, IT, or related fields.
About Fortrea
Fortrea is a global CRO providing clinical trial solutions to biotech and pharmaceutical companies. With a focus on innovation, compliance, and efficiency, Fortrea supports drug development through data integrity, regulatory expertise, and advanced technology.
Why Join Fortrea?
- Remote work options (Bangalore-based).
- Career growth in clinical research & data management.
- Exposure to global clinical trials and regulatory standards.
How to Apply?
Interested candidates can apply before the deadline: