IRT Systems Lead for Clinical Trials

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

Benefits offered by this job

Healthcare

Well-being program

Family planning benefits

Generous paid time off

Savings & investments

Location-specific perks

Job summary

Moderna Therapeutics is seeking a Manager, Clinical Supplies Systems to lead IRT systems across Moderna’s studies. You will partner with external vendors and internal stakeholders to design, implement, and deliver IRT solutions on time, maintaining high attention to detail and a collaborative approach.

The role requires 3–6 years in clinical supply systems with strong IRT expertise, vendor management experience, and knowledge of regulatory guidelines.

Qualifications

• Bachelor’s degree in a science-based subject is required; advanced degree preferred.
• Three to six years of clinical supply systems experience.
• Experience with IRT integrations (IRT/EDC) is highly desirable.

Responsibilities

• Manage IRT Systems for assigned programs and studies with autonomy.
• Lead IRT implementation project management, requirements/design, UAT, and maintenance.
• Facilitate IRT support, data changes, and collaboration with Clinical Operations and Monitoring.
• Create UAT test cases and oversee documentation and risk assessments.
• Ensure SOP adherence and document administration in eTMF.
• Coordinate cross-functional scheduling, training, and project meetings.
• Deliver excellent customer service and technical support to Clinical Ops, Biostatistics, and Data Management.
• Serve as IRT Subject Matter Expert across Moderna departments.
• Possibly expand responsibilities with experience.

Skills

IRT systems

Vendor management

UAT & testing

SOP compliance

MS Office proficiency

Problem solving

Cross-functional collaboration

ICH/GAMP/FDA knowledge

Education

Bachelor’s degree in science

Tools

MS Office

Job description

Moderna Therapeutics is seeking a Manager, Clinical Supplies Systems to lead IRT systems across Moderna’s studies. You will partner with external vendors and internal stakeholders to design, implement, and deliver IRT solutions on time, maintaining high attention to detail and a collaborative approach.

The role requires 3–6 years in clinical supply systems with strong IRT expertise, vendor management experience, and knowledge of regulatory guidelines.