Role Overview
The Senior Clinical Data Analyst at Fortrea plays a critical role within the Clinical Data Management (CDM) function, acting as a key contributor to project delivery and as a backup to the Clinical Data Manager (CDM Lead). This role combines hands-on execution of clinical data review and query management with coordination responsibilities, ensuring that clinical datasets meet stringent client quality, integrity, and regulatory standards within defined timelines and budgets. The position also contributes to study setup, process standardization, and team capability building.
Core Responsibilities
Lead and coordinate clinical data review, query generation, resolution, and reconciliation activities across assigned projects.
Ensure all data management activities comply with study protocols, global harmonized SOPs, and Good Clinical Practice (GCP) standards.
Review clinical trial data in accordance with Data Management Plans (DMPs), Edit Check Specifications (ECS), and Data Review Guidelines (DRGs), identifying discrepancies and initiating corrective actions.
Generate, track, and resolve queries arising from aggregate data review to ensure data accuracy and completeness.
Execute reconciliation processes across multiple data sources to ensure consistency and regulatory compliance.
Technical & Operational Execution
Run diagnostic programs, special listings, and discrepancy reports to support comprehensive data review.
Perform database extracts and support internal data listing reviews.
Create and validate dummy/test data to test edit checks, database screens, and SAS-generated reports and listings.
Modify standard templates to develop study-specific Data Management Plans and eCRF completion guidelines.
Assist in database setup, maintenance, and closure activities, including database lock procedures.
Documentation & Compliance
Maintain accurate and audit-ready documentation aligned with regulatory requirements and internal SOPs.
Support eTMF (electronic Trial Master File) maintenance and ensure proper documentation filing.
Generate study status reports and ensure timely reporting to stakeholders.
Cross-Functional Collaboration
Collaborate with cross-functional teams including clinical operations, biostatistics, programming, and project management.
Participate in investigator meetings, site initiation visits, and project review sessions.
Support creation of presentation materials (slides, memos, forms) for internal and external stakeholders.
Leadership & Mentorship
Act as a backup to the Clinical Data Manager, providing oversight of data management deliverables, timelines, and budgets.
Train and mentor junior team members on project-specific data management processes and best practices.
Support onboarding and capability development within the team.
Organizational Impact
Ensures delivery of high-quality, regulatory-compliant clinical datasets critical for submissions and decision-making.
Enhances operational efficiency by coordinating data management workflows and resolving data issues proactively.
Contributes to successful clinical trial execution by maintaining data integrity and adherence to timelines.
Work Environment
Operates in an office and/or home-based hybrid structure with high accountability for project deliverables.
Requires strong multitasking ability, attention to detail, and adherence to productivity metrics.
Company Context
Fortrea is a global CRO providing clinical development and data management services, offering exposure to international clinical trials, regulatory frameworks, and diverse therapeutic areas.