Senior Clinical Data Specialist – Local Labs

About the role

Fortrea is expanding its Clinical Data Management team and seeks a Senior Clinical Data Specialist focused on local laboratory data. You will lead the delivery, quality, and compliance of lab data across global clinical trials, working closely with sponsors, CROs, and internal cross‑functional teams.

Key responsibilities

• Lead local laboratory data management activities for assigned studies, ensuring timely and high‑quality data delivery.
• Oversee in‑house and vendor‑performed lab activities, aligning them with study protocols, GCP, and regulatory standards.
• Coordinate vendor and site interactions for data acquisition, transfer, reconciliation, and query resolution.
• Develop and implement standards, processes, and tools for lab data handling, including specifications, quality checks, and system integrations.
• Collaborate with Clinical Operations, Biometrics, Medical Monitoring, and Regulatory teams to align lab data timelines with overall study deliverables.
• Act as the Data Management subject‑matter expert for local lab topics in project meetings.
• Identify and drive continuous‑improvement initiatives to enhance data quality and efficiency.
• Manage risks and resolve issues related to lab data collection, transfer, and reconciliation.

Required profile

• Proven experience in clinical data management, specifically with local laboratory data.
• Strong knowledge of GCP, regulatory requirements, and clinical trial processes.
• Experience overseeing external vendors and CROs for lab data delivery.
• Ability to work cross‑functionally with operations, biometrics, medical monitoring, and regulatory teams.
• Excellent documentation and audit‑readiness skills.

Required skills