Sobre este puesto de Senior Specialist, External Data Acquisition and Delivery en Regeneron
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.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Specialist, External Data Acquisition and Delivery to join our Clinical Data Management team in a hybrid role. In this role, you will manage end-to-end non-Case Report Form data across assigned studies or Clinical Development Units - developing or amending Data Transfer Specifications of low to medium complexity with minimal supervision, performing external data reconciliation and ensuring vendor data is accurately transferred and cleaned in accordance with study protocols and Data Management Plan - while collaborating with external data vendors, CRO partners and cross-functional stakeholders. Ensure compliance with Regeneron SOPs, regulatory requirements, and industry best practices. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Hyderabad (hybrid)
Discover your role:
- Develop Data Transfer Specifications (DTS) for assigned studies or Clinical Development Units as per study timelines.
- Author and maintain DTS documents using standard templates and CDISC requirements, in collaboration with internal and external stakeholders.
- Act as the primary technical point of contact between clinical data management and vendors.
- Respond to vendor and stakeholder queries to ensure external data is complete, correctly structured and delivered in the required format.
- Track DTS status, milestones and deliverables across data types and programs, escalating issues and following through to resolution.
- Process change requests, support data structure issue resolution and facilitate the creation of new test codes where required.
- Reconcile external vendor data against clinical database to ensure accurate transfer, completeness and consistency across all data sources.
- Support data locking, archival, reconciliation documentation, eTMF maintenance and ensure inspection readiness standards.
- Provide review of protocol requirements, vendor specifications, and operational data flows with minimal supervision.
- You guide CROs, vendors and cross-functional partners with clear technical direction while identifying areas for process improvement.
This role requires:
- Bachelor's degree in Science, Health, Mathematics, Engineering, Computational or related field.
- 4+ years in external clinical data acquisition or management within biotechnology, pharmaceutical or a health-related industry.
- Experience managing multiple clinical data types and formats such as biomarker, eCOA, imaging, ECG, PK, genomics and laboratory data.
- Knowledge of 21 CFR Part 11, ICH-GCP guidelines and CDISC standards for data collection.
- Proficiency extracting data into SAS, CSV and XML formats.
- Experience with EDC platforms such as Medidata Rave, Veeva or Oracle Inform, and external data reconciliation and query processes between EDC and vendor systems.
- Basic knowledge of database structures and protocol review as relevant to clinical data management is preferred.
- Ability to draw from wide-ranging experience to resolve complex issues.
- Strategic thinking, creativity, and problem-solving skills essential
- Ability to work effectively with and motivate virtual teams in a matrix environment.
- Good interpersonal, oral, and written communication skills.
- Society of Clinical Data Management certification is recommended.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
