Senior EDC Data Specialist

Job Summary

A company is looking for a Senior EDC External Data Specialist, eSource.

Key Responsibilities

• Execute deliverables for Standardized External Data Streams and complex novel External Data Streams
• Assess external data collection requirements and manage the set-up activities to meet study timelines
• Liaise with data stakeholders and external data providers to ensure compliance and alignment on data transfer agreements

Required Qualifications

• Bachelor's degree in life science or related field and/or 5+ years of relevant experience in a Pharmaceutical or Clinical Research Organization
• Experience integrating and managing data sources such as HL7, FHIR, and EMRs into Medidata Rave
• Knowledge of trial-specific Data Transfer Agreements (tsDTA), tSDV, and JSON files preferred
• Oncology experience is strongly preferred but not required