Manager, Local Lab Delivery

Regeneron Pharmaceuticals, Inc.; Hyderabad; In loco; INR 1.800.000 - 2.400.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. seeks a Manager, Local Lab Delivery to lead a team responsible for setup, management, and delivery of local laboratory data for global clinical trials.

You will ensure accurate configuration, standardization, and integration of laboratory data into study systems while upholding regulatory and quality requirements. You'll collaborate with Clinical Data Management, Clinical Operations, Central and Local Laboratories, Study Teams, and Technology partners to deliver

Competenze

• Bachelor's degree in Life Sciences or related field required.
• 7+ years in Clinical Data Management or related fields.
• 5+ years delivering local laboratory data in clinical trials.
• Prior people management or leadership experience.
• Strong knowledge of GCP and clinical trial processes.

Mansioni

• Lead and mentor the Local Lab Delivery team.
• Oversee end-to-end local laboratory setup for trials.
• Ensure accurate configuration of lab metadata and mappings.
• Collaborate with CDM and Clinical Operations to support study start-up.
• Monitor timelines and ensure milestone delivery.
• Support inspections, audits, and regulatory activities.
• Maintain SOPs and operational documentation.
• Coordinate with external vendors and CROs.

Conoscenze

Team leadership

Regulatory compliance awareness

Project coordination

Clinical data management understanding

Formazione

Bachelor's degree in Life Sciences / Pharmacy / Biotechnology / Computer Science

Strumenti

Medidata Rave

Oracle Inform

Other clinical data platforms

Descrizione del lavoro

The Manager, Local Lab Delivery is responsible for leading a team that supports the setup, management, and delivery of local laboratory data for global clinical trials. This role ensures that laboratory data is accurately configured, standardized, and integrated into clinical study systems while maintaining compliance with regulatory and quality requirements.

The individual will work closely with Clinical Data Management, Clinical Operations, Central Laboratories, Local Laboratories, Study Teams, and Technology partners to ensure timely and high-quality laboratory data delivery across multiple studies.

Key Responsibilities

• Lead and manage the Local Lab Delivery team, providing mentorship, coaching, and performance management.


• Oversee end-to-end local laboratory setup activities for clinical trials.


• Ensure accurate configuration of:


• Laboratory metadata


• Analyte mappings


• Local laboratory reference ranges


• Unit conversions and standardization


• Collaborate with Clinical Data Management and Clinical Operations teams to support study start-up activities.


• Review laboratory specifications and ensure alignment with protocol requirements.


• Drive quality control and data validation processes for laboratory data.


• Monitor study timelines and ensure deliverables are completed according to project milestones.


• Identify process improvement opportunities and implement efficiencies within laboratory data workflows.


• Support inspections, audits, and regulatory compliance activities.


• Maintain SOPs, work instructions, and operational documentation.


• Partner with external vendors, CROs, and laboratories to ensure smooth execution of laboratory-related activities.


• Track team metrics, workload allocation, and resource planning.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or related discipline.


• 7+ years of Clinical Data Management, Laboratory Data Management, or Clinical Trial Operations experience.


• 5+ years of experience supporting local laboratory delivery, laboratory data setup, or laboratory data management in clinical trials.


• Prior people management or team leadership experience.


• Strong understanding of clinical trial processes and GCP guidelines.


• Experience working with EDC systems such as:


• Medidata Rave


• Oracle Inform


• Other clinical data platforms


• Experience managing laboratory reference ranges, analyte mapping, and metadata configuration.