Application Deadline:
- Clinical Data Specialist: April 17, 2025 (10 hours left)
- Safety System Coordinator II: April 23, 2025 (6 days left)
About Fortrea
Fortrea is a leading global contract research organization (CRO) that partners with biopharmaceutical and medical device companies to deliver innovative clinical development solutions. With a focus on data integrity, regulatory compliance, and patient safety, Fortrea provides end-to-end clinical trial management, data management, and pharmacovigilance services.
Join Fortrea’s dynamic team in Bangalore and contribute to groundbreaking clinical research while advancing your career in a collaborative and growth-oriented environment.
1. Job Opening: Clinical Data Specialist
Job Overview
The Clinical Data Specialist will be a key member of the project team, responsible for clinical data review, query resolution, and reconciliation activities. This role ensures high-quality data delivery in compliance with protocols, SOPs, and GCP standards.
Key Responsibilities
- Conduct clinical trial data review per Data Management Plans (DMP) and Data Review Guidelines.
- Generate and resolve data queries to address discrepancies.
- Assist in database setup, testing, and validation (eCRF specifications, edit checks).
- Support database lock/unlock activities and ensure timely data delivery.
- Prepare data listings, reports, and study status updates for sponsor meetings.
- Train new staff on data management processes and best practices.
Qualifications & Experience
- Education: Degree in life sciences, health sciences, IT, or related field.
- Experience: 3-5 years in clinical data management (CDM) with knowledge of therapeutic areas.
- Skills:
- Proficiency in medical terminology (preferred).
- Strong time management and organizational skills.
- Familiarity with SAS, EDC systems, and data reconciliation.
- Excellent communication and teamwork abilities.
Preferred Qualifications
- Knowledge of Fortrea SOPs and clinical trial processes.
- Experience with dummy data creation, edit check testing, and eCRF design.
Work Environment
- Hybrid (Office/Remote) with flexible shifts.
- May require overtime/weekend work based on project needs.
2. Job Opening: Safety System Coordinator II
Job Overview
The Safety System Coordinator II will support pharmacovigilance (PV) system implementation, configuration, and maintenance, ensuring compliance with safety regulations.
Key Responsibilities
- Configure and maintain safety databases (Argus, ARISg, Veeva).
- Develop standard and ad-hoc safety reports (PSURs, DSURs, listings).
- Support data migration, UAT (User Acceptance Testing), and issue resolution.
- Manage ticket support systems and resolve technical queries.
- Ensure compliance with global PV regulations and SOPs.
Qualifications & Experience
- Education: Degree in life sciences, IT, or related field (or equivalent experience).
- Experience: 1+ years in drug safety systems (Argus/ARISg/Veeva).
- Skills:
- Knowledge of SQL programming (preferred).
- Experience with validated document management systems.
- Proficiency in Microsoft Office and ticket management tools.
Preferred Qualifications
- Clinical systems experience (e.g., EDC, CTMS).
- Understanding of system integrations and pharmacovigilance workflows.
Work Environment
- Office-based or remote.
- Collaborative team setting with global stakeholders.
