Manager, Local Lab Delivery

Role & responsibilities

• Advanced knowledge of local laboratory reference range management, including analyte interpretation, reference range evaluation, unit conversions, conversion algorithms, test synonym mapping, and local laboratory metadata management.
• Advanced understanding of local laboratory data collection, validation, maintenance, and delivery processes supporting Clinical Data Management activities.
• Experience managing local laboratory data operations, quality control activities, and operational delivery processes within a regulated clinical development environment.
• Experience interpreting local laboratory reports, local laboratory reference range documentation, units of measure, analyte mappings, and related local laboratory metadata, including support of metadata maintenance, analyte library management, harmonization, and reuse initiatives.
• Strong knowledge of clinical trial processes, Clinical Data Management principles, and the role of local laboratory data throughout the clinical development lifecycle.
• Experience establishing, monitoring, and improving operational metrics, KPIs, quality indicators, turnaround times, and delivery performance.
• Strong knowledge of EDC systems, laboratory administration systems, and related clinical data technologies.
• Experience managing local laboratory data issues, including root cause analysis, CAPA development, issue resolution, and process remediation activities. • Strong understanding of applicable regulations, GxP requirements, clinical data quality principles, and inspection readiness expectations.
• Demonstrated ability to drive operational excellence, process improvements, and organizational change initiatives.
• Strong analytical, problem-solving, organizational, and decision-making skills. • Strong stakeholder management, influencing, and cross-functional collaboration skills.
• Experience partnering with Clinical Data Management, Clinical Operations, study teams, laboratory vendors, and technology teams.
• Exposure to automation, AI-enabled solutions, workflow optimization, metadata management, or digital transformation initiatives supporting laboratory data management is preferred.

Preferred candidate profile

• 7+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, CRO, or healthcare industry.

Regeneron - Confidential

• 5+ years of direct Local Laboratory Delivery experience
• 2+ years of people management experience