IRT Systems Lead for Clinical Supplies & Integrations

BioSpace; Cambridge (MA); On-site; USD 122,000 - 195,000; Full time

Job summary

Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This role partners with external IRT vendors to ensure timelines and alignment with internal stakeholders, designing system requirements and delivering on-time integrations.

You will lead cross-functional teams, manage UAT and documentation to eTMF, and mentor Clinical Supply Systems Specialists. A strong background in IRT and regulatory knowledge is essential.

Qualifications

• Three to six years of clinical supply systems experience.
• Science-based bachelor’s degree; advanced degree preferred.
• Demonstrated product ownership experience is preferred.
• Strong integration experience between IRT, EDC, and clinical systems.
• Knowledge of cold chain implications for IRT.
• Proficient with ICH, GAMP, FDA, IRB/IEC regulations.
• Proven relationship-building with vendors and cross-functional teams.
• Solid MS Office and SharePoint skills.

Responsibilities

• Manage IRT systems for assigned programs with autonomy.
• Lead IRT implementation projects, requirements, UAT, and maintenance.
• Mentor Clinical Supply Systems Specialists.
• Coordinate with operations to achieve goals and deliverables.
• Create test plans, signatures, risk assessments and documentation.
• Ensure SOP compliance and proper eTMF uploads.
• Collaborate cross-functionally for scheduling and training.
• Provide exemplary customer service to clinical operations and data teams.
• Serve as IRT SME to Moderna departments.

Skills

Clinical supply systems

IRT expertise

Vendor management

Project ownership

MS Office tools

Regulatory knowledge (ICH, GAMP, FDA)

eTMF documentation

Data-driven problem solving

Education

Bachelor’s degree in a science-based subject

Tools

MS Office

eTMF system

Job description

Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This role partners with external IRT vendors to ensure timelines and alignment with internal stakeholders, designing system requirements and delivering on-time integrations.

You will lead cross-functional teams, manage UAT and documentation to eTMF, and mentor Clinical Supply Systems Specialists. A strong background in IRT and regulatory knowledge is essential.