Manager, Local Lab Delivery

Regeneron Pharmaceuticals, Inc.; Hyderabad; Hybrid; INR 3,000,000 - 4,200,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Hyderabad (hybrid) seeks a Manager to lead local laboratory data delivery across clinical studies. You will oversee reference ranges, units, mappings, and metadata within laboratory systems, ensuring accuracy and data quality.

You will coach a team of Local Lab Delivery Specialists, partnering with Clinical Data Management, Clinical Operations, and external vendors to enable timely delivery and continuous improvement through automation and CAPA-driven solutions.

Qualifications

• Bachelor's degree or higher in a science/related field.
• 7+ years Clinical Data Management experience in biotech/pharma/healthcare.
• 5+ years Local Lab Delivery experience and 2+ years people management.

Responsibilities

• Lead the operational delivery of local laboratory data activities across studies, ensuring timely execution and quality.
• Oversee intake, interpretation, quality control, maintenance of local lab reference ranges and metadata.
• Ensure configuration and maintenance of local lab data within EDC/Lab Admin systems.
• Provide guidance on study-specific local lab setup, metadata, and complex data issues.
• Maintain and harmonize local lab metadata assets, including analyte libraries and reference ranges.
• Escalate complex issues, perform root cause analysis, CAPA development, and remediation.
• Collaborate with Clinical Data Management, Clinical Operations, study teams, and external partners to drive delivery.
• Establish turnaround times, metrics, and quality indicators for study startup and database lock.

Skills

Lab data management

Leadership

Root cause analysis

CAPA development

Cross-functional collaboration

Process improvement

SOPs & quality standards

Education

Bachelor's degree in Science

Tools

EDC systems

Lab administration systems

Job description

Build our future together:

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Local Lab Delivery to lead the operational delivery, oversight, and continuous improvement of local laboratory reference range data management supporting our clinical development portfolio. In this role, you will oversee the end-to-end local laboratory data process, ensuring reference ranges, units, conversion factors, analyse mappings, and associated metadata are accurately interpreted, quality controlled, maintained, and configured within laboratory management systems. You will also lead and develop a team of Local Lab Delivery Specialists and collaborate across Clinical Data Management, Clinical Operations, study teams, technology teams, and external partners.

When & where

Hyderabad (hybrid)

Discover your role:

• Lead the operational delivery of local laboratory data activities across clinical studies, ensuring timely execution, quality oversight, issue resolution, and effective study support.
• Oversee the intake, interpretation, quality control, maintenance, and delivery of local laboratory reference ranges and metadata, including units, conversion factors, analyse mappings, and study-specific configurations.
• Ensure accurate and timely configuration, maintenance, and quality oversight of local laboratory information within the EDC Lab Administration system.
• Provide consultation and guidance on study-specific local laboratory setup requirements, metadata, and complex local laboratory data issues.
• Oversee the maintenance, harmonization, and reuse of local laboratory metadata assets, including analyte libraries, laboratory templates, analyte mappings, units of measure, and reference range information.
• Serve as the escalation point for complex local laboratory data issues and lead root cause analysis, CAPA development, issue resolution, and process remediation activities.
• Partner with Clinical Data Management, Clinical Operations, study teams, system owners, technology teams, laboratory vendors, and external partners to drive successful local laboratory delivery.
• Establish and monitor turnaround times, operational targets, and quality metrics supporting study startup, ongoing data management activities, and database lock achievements.
• Ensure local laboratory data processes, systems, and documentation comply with SOPs, work instructions, quality standards, GxP requirements, and inspection-readiness expectations.
• Drive continuous improvement and technology enablement, including opportunities involving automation, AI-enabled solutions, document extraction, unit harmonization, metadata classification, test synonym mapping, and quality review.
• Lead, coach, mentor, and develop a team of Local Lab Delivery Specialists while managing performance objectives, development plans, workload allocation, resource planning, and operational priorities.

This role requires:

• Bachelor's degree in Science, Health, Data Management, Mathematics, Computing, or a related field.
• 7+ years of Clinical Data Management experience within biotechnology, pharmaceutical, CRO, or healthcare environments.
• 5+ years of direct Local Laboratory Delivery experience and 2+ years of people management experience.
• Advanced knowledge of local laboratory reference range management, including analyte interpretation, unit conversions, conversion algorithms, test synonym mapping, reference range evaluation, and metadata management.
• Strong understanding of local laboratory data collection, validation, maintenance, quality control, and delivery processes supporting Clinical Data Management.
• Strong knowledge of clinical trial processes, Clinical Data Management principles, EDC systems, laboratory administration systems, and related clinical data technologies.
• Experience managing complex laboratory data issues through root cause analysis, CAPA development, issue resolution, and process remediation.
• Knowledge of applicable regulations, GxP requirements, clinical data quality principles, SOPs, and inspection-readiness expectations.
• Demonstrated experience with operational metrics, targets, turnaround times, quality indicators, process improvement, and operational excellence.
• Strong leadership and people-management capabilities, including coaching, mentoring, performance management, resource planning, and staff development.
• Strong analytical, problem-solving, decision-making, stakeholder management, and cross-functional collaboration skills.
• Exposure to automation, AI-enabled sol