Senior Specialist, External Data Acquisition and Delivery
Regeneron · Hyderabad
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What they're looking for
- Bachelor's degree in Science, Health, Mathematics, Engineering, or related field
- 4+ years external clinical data acquisition or management in biotech/pharma
- Experience with multiple clinical data types including biomarker, eCOA, imaging, ECG, PK, genomics
- Knowledge of 21 CFR Part 11, ICH-GCP guidelines, and CDISC standards
- Proficiency extracting data into SAS, CSV, and XML formats
- Experience with EDC platforms such as Medidata Rave, Veeva, or Oracle Inform
- Strong problem-solving and communication skills in matrix environments
What you'll be doing
- Develop and maintain Data Transfer Specifications for assigned studies using CDISC standards
- Serve as primary technical contact between clinical data management and external vendors
- Reconcile external vendor data against clinical database for accuracy and completeness
- Track DTS status, milestones, and deliverables; escalate and resolve issues
- Support data locking, archival, reconciliation documentation, and eTMF maintenance
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.