Manager, External Data Acquisition and Delivery

Regeneron Pharmaceuticals, Inc; Hyderabad; Hybrid; INR 2,500,000 - 3,800,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager of External Data Acquisition and Delivery to join the Clinical Data Management team in a hybrid role in Hyderabad.

You will lead external data acquisition, delivery, and reconciliation across Clinical Development Units, ensuring high-quality and compliant data management practices. You will develop Data Transfer Specifications (DTS), oversee vendors, and collaborate with CROs and cross-functional teams to ensure timely data delivery.

Qualifications

• Bachelor's degree in Science, Health, Mathematics, Engineering, Computational Sciences, or a related field.
• 7+ years of experience in External Clinical Data Acquisition or Clinical Data Management within biotechnology, pharmaceutical, or healthcare industries.
• Experience handling multiple clinical data types including biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data.
• Solid understanding of CDISC standards, database structures, and clinical data management procedures.
• Knowledge of regulatory requirements, including 21 CFR Part 11 and ICH-GCP guidelines.
• Sophisticated experience extracting and handling data in SAS, CSV, and XML formats.
• Experience with EDC platforms such as Medidata Rave, Veeva, Oracle Inform, and external data reconciliation processes.
• Strong project management, analytical, problem-solving, and strategic thinking skills.

Responsibilities

• Lead external data acquisition, delivery, and reconciliation activities across assigned Clinical Development Units.
• Develop medium to high complexity Data Transfer Specifications (DTS) aligned with CDISC standards and Regeneron processes.
• Provide vendor oversight, onboarding, performance monitoring, and issue escalation for data vendors.
• Track DTS milestones, results, and timelines across programs and data domains.
• Support protocol reviews, vendor specifications, and data structure requirements.
• Perform and supervise reconciliation between EDC and vendor data systems to ensure data integrity.
• Collaborate with DB Development, Biostatistics, Data Managers, and external partners to resolve data discrepancies.
• Monitor data trends, identify risks, and support continuous improvement across External Data Services.
• Support inspection readiness activities, data locking, eTMF maintenance, and archival processes.

Skills

External data acquisition

Data management

CDISC standards

SAS

EDC platforms

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Science/Health/Math/Engineering/Computational Sciences

Tools

Medidata Rave

Veeva

Oracle Inform

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.

We are seeking a Manager, External Data Acquisition and Delivery to join our Clinical Data Management team in a hybrid role. In this role, you will lead external data acquisition, delivery, and reconciliation activities across assigned Clinical Development Units, ensuring high-quality and compliant external data management practices. You will be responsible for the development of medium to high complexity Data Transfer Specifications (DTS), handle vendor oversight activities, support inspection readiness, and partner with CROs, external data providers, and cross-functional stakeholders to ensure timely and accurate delivery of external clinical data. This position offers the opportunity to drive data integrity, enhance operational perfection, and support successful study execution in a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Hyderabad (Hybrid)

Discover your role:

• Lead the development, maintenance, and governance of Data Transfer Specifications (DTS) for assigned studies and Clinical Development Units.
• Author DTS documents in alignment with CDISC standards and Regeneron processes while collaborating with internal and external partners.
• Act as a key liaison between Clinical Data Management, CROs, external vendors, and study teams to ensure successful external data delivery.
• Provide oversight for external data vendors, including onboarding, performance monitoring, issue resolution, and escalation management.
• Track DTS milestones, results, and timelines across multiple programs and data domains.
• Support protocol reviews, vendor specifications, operational data flows, and data structure requirements.
• Perform and supervise reconciliation between EDC and vendor data systems to ensure data integrity, completeness, and consistency.
• Collaborate with Database Development, Biostatistics, Data Managers, and external partners to investigate and resolve data discrepancies.
• Monitor data trends, identify risks, and support continuous improvement initiatives across External Data Services.
• Support inspection readiness activities, reconciliation documentation, audit trails, eTMF maintenance, data locking, and archival activities.
• Mentor and coach junior associates while serving as a Subject Matter Expert across external data domains.
• Contribute to SOPs, work instructions, guidance documents, training programs, and other External Data Services tools and templates.

This role requires:

• Bachelor's degree in Science, Health, Mathematics, Engineering, Computational Sciences, or a related field.
• 7+ years of experience in External Clinical Data Acquisition or Clinical Data Management within biotechnology, pharmaceutical, or healthcare industries.
• Experience handling multiple clinical data types including biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data.
• Solid understanding of CDISC standards, database structures, and clinical data management procedures.
• Knowledge of regulatory requirements, including 21 CFR Part 11 and ICH-GCP guidelines.
• Sophisticated experience extracting and handling data in SAS, CSV, and XML formats.
• Experience with EDC platforms such as Medidata Rave, Veeva, Oracle Inform, and external data reconciliation processes.
• Strong project management, analytical, problem-solving, and strategic thinking skills.
• Ability to influence and collaborate effectively across global, cross-functional, and matrixed teams.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to thrive in a fast-paced environment while handling multiple priorities and timelines.
• Society of Clinical Data Management (SCDM) certification is preferred.

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, and 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. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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