Role Overview
The Clinical Data Analyst role within CPS Data Management at Fortrea focuses on supporting the delivery of high-quality clinical trial data by executing core data management activities. The position operates under the guidance of the Lead Data Reviewer (LDR) or Lead Data Manager (LDM), ensuring that clinical datasets meet regulatory, client, and internal quality standards while adhering to strict timelines and productivity expectations.
Core Responsibilities
Execute comprehensive clinical data review activities to ensure accuracy, completeness, and consistency of clinical trial data.
Perform query management, including generation, resolution, and tracking of queries to address missing, inconsistent, or erroneous data.
Review clinical data in accordance with Data Management Plans (DMPs), Edit Check Specifications (ECS), and Data Review Guidelines (DRGs).
Identify data discrepancies and proactively raise queries for timely resolution.
Support reconciliation activities between different clinical datasets to ensure data alignment and integrity.
Technical & Operational Execution
Develop and execute ancillary programs such as diagnostics, discrepancy listings, and special reports to facilitate efficient data review.
Assist in the creation and review of Edit Check Specifications to ensure robust validation rules within clinical databases.
Generate and utilize dummy/test data to validate edit checks, database functionality, and SAS-generated reports and listings.
Support testing and validation of database screen design and system functionality.
Contribute to the generation of study status reports and project tracking outputs.
Documentation & Compliance
Maintain and update Data Management documentation in compliance with internal SOPs and regulatory requirements.
Support eTMF (electronic Trial Master File) maintenance and ensure proper documentation filing and audit readiness.
Adhere strictly to client-specific quality standards, regulatory guidelines, and internal compliance frameworks.
Cross-Functional Collaboration
Collaborate with cross-functional project teams including clinical operations, biostatistics, and programming teams.
Participate in project meetings and contribute to discussions on data quality, timelines, and issue resolution.
Support the setup, maintenance, and closure phases of clinical data management activities across studies.
Organizational Impact
Ensures delivery of high-quality, audit-ready clinical datasets that directly support regulatory submissions and clinical decision-making.
Plays a critical role in maintaining data integrity across clinical trials, thereby contributing to patient safety and scientific validity.
Supports operational efficiency and adherence to timelines within clinical data management projects.
Work Environment
Operates in a structured office and/or home-based environment with defined project timelines and deliverables.
Requires strong attention to detail, adherence to SOPs, and the ability to manage multiple concurrent tasks.
Company Context
Fortrea is a global contract research organization (CRO) specializing in clinical development and data management services, offering opportunities to work on global clinical trials and diverse therapeutic areas.