Regeneron Pharmaceuticals, Inc. logo

Specialist, External Data Acquisition and Delivery

Regeneron Pharmaceuticals, Inc.
NewPosted today

LOCATION

Hyderabad · Hybrid

EXPERIENCE

2+ Years

TYPE

FullTime

SKILLS REQUIRED

CDISC StandardsData Transfer SpecificationsData ReconciliationClinical Data ManagementSQL

Job description

Overview

Manage non-Case Report Form data across assigned studies or Clinical Development Units, collaborating with external data vendors, CRO partners, Clinical Data Management and cross-functional stakeholders.

What you'll do

  • Manage end-to-end non-Case Report Form data delivery.
  • Develop low-complexity Data Transfer Specifications for assigned studies.
  • Reconcile external vendor data with clinical database outputs.
  • Track specification status across data types and programmes.
  • Support data structure issue resolution and change requests.
  • Maintain documentation, audit trails and inspection readiness standards.
  • Collaborate across teams to resolve data discrepancies.
  • Support continuous improvement in external data processes.

What you'll need

  • Bachelor's degree in Science, Health, Mathematics, Engineering, Computational or related field.
  • 2+ years in external clinical data acquisition or management.
  • Experience managing clinical data types such as biomarker, eCOA, imaging, ECG, PK, genomics and laboratory data.
  • Knowledge of 21 CFR Part 11, ICH-GCP and CDISC standards.
  • Experience extracting data into SAS, CSV and XML formats.
  • Knowledge of EDC platforms and external data reconciliation processes.

Details

  • Location: Hyderabad.
  • Work mode: hybrid.
  • Many roles are required to be performed on-site; confirm on-site expectations with the recruiter and hiring manager.

Read the full description and apply on the company’s own careers page.

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Specialist, External Data Acquisition and Delivery