Senior Clinical Data Platform Architect (EDC/CDISC)

Emmes Group

Rockville (MD)

On-site

USD 120,000 - 160,000

Full time

31 hours ago

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Job summary

Emmes Group is seeking a Principal Clinical Database Developer to lead EDC configuration, eCRF design, and CDISC standard implementation. The role combines technical subject-matter expertise with potential Product Owner or Scrum Master responsibilities on an Agile team.

You will drive complex data system features, validate data, and ensure regulatory compliance across clinical trials in a collaborative setting.

Qualifications

Strong experience with electronic data capture (EDC) platform configuration and eCRF design.
Proficient in CDISC standards (CDASH, SDTM) within EDC.
Experience leading Agile teams as Product Owner or Scrum Master is a plus.

Responsibilities

Designs and configures eCRFs and related data checks; leads as expert in eCRF layout and database design.
Configures complex protocols, visit schedules, and site structures in the data system builder.
Advises on advanced features (ePRO, specimen tracking, randomization) for clinical data systems.
Performs data validation, testing, and quality control with accuracy; writes and executes test scripts.
Implements Data Migration Plans and data integration/transfer work; supports global standards development.
Ensures compliance with ICH/GCP and relevant regulations; maintains documentation and version control.