IRT Systems Lead - Clinical Supply & Trials

Moderna Therapeutics Inc.; Cambridge (MA); Hybrid; USD 122,000 - 195,000; Full time

Benefits offered by this job

Healthcare

Well-being benefits

Family planning

Generous PTO

Year-end shutdown

Job summary

Moderna Therapeutics Inc. in Cambridge, MA seeks an experienced IRT Lead to autonomously manage Interactive Response Technology (IRT) systems across the clinical portfolio.

You will translate complex clinical and supply requirements into robust system designs and oversee end-to-end lifecycle from requirements through deployment and maintenance. The role emphasizes collaboration with Clinical Operations, Monitoring, Biostatistics, Clinical Supplies and Data Management, with a strong focus on risk

Qualifications

• Experience in clinical supply systems within a biopharma or CRO setting.
• Demonstrated ownership of product-related initiatives in a regulated environment.
• Knowledge of IRT, EDC integrations and cross-functional clinical operations.
• Strong vendor management and relationship-building skills.
• Familiarity with ICH, GAMP, FDA and related clinical research regulations.

Responsibilities

• Manage IRT systems for assigned programs and studies.
• Lead end-to-end IRT implementation activities from requirements to testing and deployment.
• Coordinate with external IRT vendors to meet milestones and deliverables.
• Develop IRT designs based on clinical development and supply needs.
• Create and oversee UAT, risk assessments and documentation.
• Escalate risks and provide strategic options to leadership.

Skills

Clinical supply systems experience

Product ownership experience

IRT expertise

Vendor relationship skills

Regulatory knowledge (ICH, FDA, etc.)

Education

Bachelor’s degree in a science-based subject

Advanced degree preferred

Tools

MS Office (Outlook, Word, Excel, PowerPoint)

Job description

Moderna Therapeutics Inc. in Cambridge, MA seeks an experienced IRT Lead to autonomously manage Interactive Response Technology (IRT) systems across the clinical portfolio.

You will translate complex clinical and supply requirements into robust system designs and oversee end-to-end lifecycle from requirements through deployment and maintenance. The role emphasizes collaboration with Clinical Operations, Monitoring, Biostatistics, Clinical Supplies and Data Management, with a strong focus on risk