Manager, External Data Acquisition and Delivery

Regeneron Pharmaceuticals; Hyderabad; Hybrid; INR 2,400,000 - 4,200,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an experienced Manager, External Data Acquisition and Delivery to lead DTS development, governance, and external data delivery across Clinical Development Units. You will collaborate with CROs, vendors and study teams to ensure data integrity and timely delivery.

The role requires 7+ years in external clinical data acquisition or data management, strong regulatory knowledge, and expertise with SAS/CSV/XML and EDC platforms.

Qualifications

• Bachelor’s degree in Science, Health, Mathematics, Engineering, Computational Sciences, or related field.
• 7+ years in External Clinical Data Acquisition or Clinical Data Management in biotech/pharma/healthcare.
• Experience with biomarker, eCOA, imaging, ECG, PK, genomics, and lab data.
• Knowledge of CDISC standards and clinical data management procedures.
• SAS, CSV, XML data handling experience.
• Experience with EDC platforms like Medidata Rave, Veeva, Oracle Inform and data reconciliation.
• Strong PM, analytical and cross-functional collaboration skills.
• SCDM certification preferred.

Responsibilities

• Lead DTS development, maintenance, and governance for studies.
• Author DTS documents following CDISC standards and Regeneron processes.
• Coordinate with Clinical Data Management, CROs, vendors, and study teams for external data delivery.
• Oversee external data vendors: onboarding, performance, issue resolution, escalation.
• Track DTS milestones and timelines across programs.
• Support protocol reviews, vendor specs, data flows, and data structure requirements.
• Supervise reconciliation between EDC and vendor data for integrity.
• Collaborate to resolve data discrepancies across teams.
• Monitor data trends and drive continuous improvement in External Data Services.
• Assist inspection readiness and audit trails activities.
• Mentor junior associates and act as SME for external data domains.
• Contribute to SOPs, work instructions, and templates.

Skills

Project management

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree in Science/Health/Engineering

Tools

SAS

CSV

XML

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.

We are committed to building a workplace with an inclusive culture. 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, 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.