Manager, Local Lab Delivery

Regeneron; Telangana; Hybrid; INR 2,500,000 - 3,800,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a senior Local Lab Delivery Lead in Hyderabad to orchestrate the operational delivery of local laboratory data across clinical studies, ensuring timely execution and quality oversight.

You will manage metadata, reference ranges, units, mappings, and study-specific configurations within the EDC Lab Administration system. Collaborating with Clinical Data Management, study teams, and external partners, you will drive CAPA, process improvements, and automation

Qualifications

• Bachelor’s degree in a science/health/data field and relevant CDM experience.
• 7+ years of Clinical Data Management experience in biotech/pharma/healthcare.
• 5+ years local laboratory delivery experience and 2+ years people management.
• Strong knowledge of local lab reference range management and data workflows.
• Experience with EDC systems and laboratory administration tools.

Responsibilities

• Lead the operational delivery of local laboratory data activities across clinical studies.
• Oversee intake, interpretation, QC, maintenance, and delivery of local lab references and metadata.
• Ensure accurate configuration and quality oversight of local lab data in the EDC Lab Administration system.
• Provide guidance on study-specific local lab setup requirements and metadata issues.
• Oversee maintenance and harmonization of local lab metadata assets and mappings.
• Serve as escalation point for complex local lab data issues and drive CAPA activities.
• Partner with cross-functional teams to drive local lab delivery success.
• Establish turnaround times, targets, and quality metrics for study startup and data management.
• Ensure processes comply with SOPs, GxP, and inspection-readiness expectations.
• Drive continuous improvement and automation opportunities in lab data management.
• Lead, coach, and develop a team of Local Lab Delivery Specialists.

Skills

Leadership

People management

Clinical Data Management

GxP knowledge

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in Science, Health, Data Management, Mathematics, Computing, or related field

Tools

EDC systems

Laboratory information 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.

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.

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 solutions, workflow optimization, metadata management, or digital transformation within laboratory data management is preferred.
• Excellent verbal, written, and interpersonal communication skills, with the ability to manage multiple priorities in a fast‑paced environment.
• May require up to 25% travel.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

For jobs in Canada: this posting is for an existing position.