Lead local laboratory data management across clinical studies, overseeing data acquisition, transfers, reconciliation, quality checks, vendor and site interactions, system configuration, and query resolution. Collaborate with sponsors and cross-functional global teams throughout study start-up, maintenance, and database lock. Ensure compliance with protocols, GCP, ICH guidelines, FDA regulations, SOPs, and audit-readiness requirements while supporting process improvements, risk management, and local lab standards.
Fortrea is expanding its Clinical Data Management team and we're looking for an Senior Clinical Data Specialist, Local Labs to join our FSP model. This is a unique opportunity to be part of a growing footprint in the region and support global clinical trials through critical laboratory data management and oversight activities.
Job Overview:
Provide Data Management leadership for local laboratory data across assigned studies and programs, with accountability for the timely delivery, quality, and compliance of local lab data. Oversee local lab activities performed in-house and by external vendors, ensuring alignment with study requirements, regulatory standards, and client expectations.
Work closely with Sponsors and cross-functional teams to support implementation of local lab data strategies, including data acquisition, integration, reconciliation, and review activities. Ensure all deliverables are completed in accordance with protocols, GCP, and applicable regulatory requirements, while supporting process optimization and continuous improvement.
Summary of Responsibilities:
- Lead local laboratory data management activities across assigned studies and programs, ensuring timely and high-quality delivery of local lab data
- Support vendor oversight activities, including coordination with CROs and third-party vendors for local lab data delivery
- Manage vendor and site interactions for local lab data acquisition, transfer, reconciliation, and query resolution
- Support development and implementation of standards, processes, and tools for local lab data handling, including specifications, quality checks, and system integrations
- Collaborate cross-functionally with Clinical Operations, Biometrics, Medical Monitoring, and Regulatory teams to align lab data management with study timelines and deliverables
- Represent Data Management as a subject matter expert (SME) for local laboratory topics in project team meetings
- Support innovation and continuous improvement initiatives, identifying opportunities to optimize processes and enhance data quality and efficiency
- Manage risks and support resolution of issues related to lab data collection, transfer, and reconciliation
- Collaborate with study teams during start-up, maintenance, and database lock activities, providing expertise on local lab requirements
- Review study protocols and requirements to identify required analytes and ensure accurate lab data setup
- Ensure global analyte libraries and lab standards are maintained and aligned with sponsor requirements
- Support configuration and maintenance of lab data within systems (e.g., adding lab locations and analyte parameters)
- Communicate local lab data collection requirements effectively to clinical and site staff
- Promote adoption of new technologies and tools to improve data management processes
- Ensure compliance with training requirements, SOPs, GCP, and regulatory standards
- Maintain accurate documentation and ensure audit readiness across all study activities
- All other duties as needed or assigned
Qualifications (Minimum Required):
- University degree in Life Sciences, Health Sciences, Information Technology, or a related field
- Equivalent experience in clinical research or data management may be considered in lieu of a formal degree
- Fluent in English, both written and verbal
- Strong understanding of clinical trial processes and data management principles
Experience (Minimum Required):
- 3+ years of experience in clinical data management and/or drug development processes
- Experience supporting or leading local laboratory data management activities
- Strong understanding of GCP, ICH guidelines, FDA regulations, and industry standards
- Knowledge of clinical trial documentation (protocols, CRFs, SAPs, study reports)
- Experience working across cross-functional teams and global stakeholders
- Strong project management skills with ability to manage multiple studies or programs simultaneously
- Experience with vendor oversight and external data management activities
- High attention to detail and commitment to quality and compliance
- Effective communication and organizational skills
Preferred Qualifications Include:
- Prior experience in FSP or CRO environments
- Experience with local laboratory data systems and integrations (e.g., EDC, Veeva Vault)
- Experience across multiple therapeutic areas and phases of development
- Knowledge of NDA/CTD processes
Physical Demands/Work Environment:
- Office and/or home-based work environment.
- May require occasional evening or weekend work to meet global timelines
- Flexible shifts may be required to support international teams
Learn more about our EEO & Accommodations request here.
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