Sr Clinical Data Specialist (Local Labs)

Job Overview:

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

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