IRT Systems Lead for Clinical Supply & Integrations

RXinsider LTD.; Cambridge, Northern (MA, KY); Hybrid; USD 122,000 - 195,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning support

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems across a growing portfolio of studies. You will collaborate with external IRT vendors and internal stakeholders to ensure timely, compliant system design and delivery.

The role requires 3–6 years of clinical supply experience, a science-based degree, and strong knowledge of IRT, EDC, and regulatory guidelines. A proactive leader who can manage multiple projects and mentor junior staff is preferred.

Qualifications

• 3–6 years of clinical supply systems experience.
• Bachelor’s degree in a science-based subject is required; advanced degree preferred.
• Prior product ownership experience strongly preferred.
• Demonstrated innovation in integrations between clinical systems (IRT, EDC, etc.).
• Understanding of Cold Chain distribution and its impact on IRT.
• IRT subject matter expertise.
• Strong vendor relationship management and cross-functional collaboration.
• Familiarity with ICH, GAMP, FDA, IRB/IEC regulations and clinical protocol requirements.

Responsibilities

• Manage IRT systems for assigned programs and studies with autonomy.
• Oversee IRT implementation project management, requirements/design, UAT, and maintenance.
• Mentor Clinical Supply Systems Specialists as applicable.
• Facilitate IRT support, data changes, and coordination with Clinical Operations and Monitoring.
• Create and review UAT test cases; manage documentation signatures and risk assessments.
• Ensure SOP compliance and upload documentation to the eTMF.
• Coordinate cross-functional project scheduling, end-user training, and meetings.
• Provide exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management.
• Serve as IRT SME to Moderna departments.

Skills

Clinical supply systems experience

IRT systems knowledge

Vendor relationship management

Regulatory knowledge (ICH, GAMP, FDA,/

Cross-functional collaboration

Education

Bachelor’s degree in a science-based subject

Advanced degree preferred

Tools

MS Office (Outlook, Word, Excel, PowerPoint, SharePoint)

Job description

Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems across a growing portfolio of studies. You will collaborate with external IRT vendors and internal stakeholders to ensure timely, compliant system design and delivery.

The role requires 3–6 years of clinical supply experience, a science-based degree, and strong knowledge of IRT, EDC, and regulatory guidelines. A proactive leader who can manage multiple projects and mentor junior staff is preferred.