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.

How to Apply

🔗 Apply for Clinical Data Specialist (Job ID: 251815)

🔗 Apply for Safety System Coordinator II (Job ID: 25792)