As an IRT Configuration Specialist, you will leverage your expertise to set up, implement, and manage IRT configurations for clinical teams. This role requires close collaboration with project teams, stakeholders, and third-party vendors to ensure IRT solutions meet study protocols, client needs, and regulatory standards.
Key Responsibilities:
IRT System Configuration:
Collaborate with clinical teams to translate study protocols into IRT requirements.
Lead discussions for initial IRT builds and oversee the project lifecycle from requirements gathering to go-live.
Implement protocol-specific requirements and manage User Acceptance Testing (UAT).
Client Engagement:
Act as the primary contact for clients during setup and maintenance.
Conduct training sessions on system functionality.
Quality Assurance:
Ensure compliance with regulatory standards (GxP, 21 CFR Part 11) in collaboration with QA teams.
Guide the data management team on IRT deliverables.
Ongoing Support:
Provide troubleshooting and support throughout the clinical trial lifecycle.
Qualifications:
Education:
Bachelor's degree in Life Sciences, Computer Science, or related field; advanced degree preferred.
Experience:
5+ years in IRT configuration or clinical trial operations.
Experience with IRT solutions (e.g., Suvoda).
Strong understanding of clinical trial processes and project management skills.
Familiarity with regulatory compliance and excellent communication skills.
Preferred Skills:
Knowledge of clinical trial data management and eClinical systems.
Project Management certification (PMP, PRINCE2) is a plus.
Proficiency in scripting or SQL for advanced configurations.
Contact: lthorup@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
