Senior edc Programmer

Immunomeinc

Bothell, United States
On-site
Edc system design and deployment
Edit checks and custom function development
Cdisc and sdtm data standards alignment
The Senior EDC Programmer leads the design, development, and maintenance of clinical trial databases to support efficient trial execution

Job Summary

  • The Senior EDC Programmer leads the design, development, and maintenance of clinical trial databases to support efficient trial execution.
  • This role requires ensuring that all EDC systems comply with strict regulatory requirements including FDA, ICH-GCP, and 21 CFR Part 11.
  • The position involves collaborating closely with Clinical Data Management, Biostatistics, and Clinical Operations teams to maintain high-quality data collection systems.

Matching Summary

The Senior EDC Programmer leads the design, development, and maintenance of clinical trial databases to support efficient trial execution.

Skills & Requirements

Must-have

  • EDC system design and deployment
  • Edit checks and custom function development
  • CDISC and SDTM data standards alignment
  • 21 CFR Part 11 regulatory compliance
  • User Acceptance Testing (UAT) execution

Nice-to-have

  • Experience with antibody-drug conjugates
  • Collaboration with external vendors
  • Database migration support experience
  • Protocol review and CRF design input

Key Requirements

  • Senior level experience in EDC programming
  • Knowledge of CDISC standards (SDTM)
  • Understanding of 21 CFR Part 11 regulations

Work Rights

Not specified

Tailored Resume

Cover Letter