Consultant

Description:

This is a part-time contract remote role for an EDC Consultant. The EDC Consultant will work closely with our product and engineering teams to advise on the development of our electronic data capture (EDC) system. Responsibilities include providing guidance on industry standards (e.g., CDASH, SDTM, 21 CFR Part 11), validating feature sets against regulatory and user requirements, reviewing data workflows, and offering strategic input on user interface and user experience for site and sponsor users. The consultant may also be asked to review prototypes, provide written feedback, and participate in planning sessions as needed.

Qualifications

• Demonstrated experience working with EDC platforms (e.g., Medidata Rave, REDCap, OpenClinica, Veeva Vault EDC, Castor, etc.)
• Strong understanding of clinical trial data standards, especially CDASH and SDTM
• Familiarity with regulatory requirements (e.g., ICH-GCP, 21 CFR Part 11, GDPR)
• Experience in protocol design, CRF development, or data management workflows
• Ability to communicate effectively with both technical and non-technical stakeholders
• Experience with early-stage software development teams is a plus
• Prior involvement in EDC vendor selection, implementation, or customization is a bonus