Manager, External Data Acquisition and Delivery

Regeneron India Private Limited; Hyderabad; Hybrid; INR 2.500.000 - 4.500.000; Vollzeit

Benefits dieser Stelle

Annual bonuses

Equity awards

Health and wellness programs

Paid time off

Zusammenfassung

Regeneron India Private Limited in Hyderabad seeks a Manager to lead external data acquisition and delivery within the Clinical Data Management team. You will govern DTS development, collaborate with CROs and vendors, and ensure data integrity across multiple studies through IS and CDISC-aligned processes.

The role requires 7+ years in external data acquisition or data management, strong regulatory knowledge, and hands-on experience with SAS, CSV, and XML data formats.

Qualifikationen

• Bachelor's degree in Science or related field.
• 7+ years of External Clinical Data Acquisition or CDMO experience.
• Experience with biomarker, eCOA, imaging, ECG, PK, genomics data.
• Strong knowledge of CDISC, 21 CFR Part 11, ICH-GCP.
• Proficient in SAS, CSV, and XML data handling.

Aufgaben

• Lead development, maintenance, and governance of Data Transfer Specifications (DTS).
• Author DTS documents per CDISC standards in collaboration with partners.
• Coordinate with Clinical Data Management, CROs, vendors, and study teams for external data delivery.
• Oversee external data vendors including onboarding, performance monitoring, and issue resolution.
• Support inspection readiness and reconciliation documentation across data flows.

Kenntnisse

External Data Acquisition

Data Management

CDISC standards

SAS

CSV

XML

Regulatory knowledge

Vendor oversight

Project management

Data reconciliation

Ausbildung

Bachelor's degree in Science

Tools

Medidata Rave

Veeva

Oracle Inform

Jobbeschreibung

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.

• 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., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.