Manager, Clinical Supply Systems

ModernaTX • Princeton, MA

1d • $121,600 - $194,500 • Hybrid

About The Position

The Manager, Clinical Supply Systems autonomously owns Interactive Response Technology (IRT) systems supporting Moderna’s clinical portfolio. Working under the guidance of a Senior Manager or Associate Director, this individual contributor leads IRT implementation and lifecycle activities for assigned programs and studies, translating clinical development, supply, and operational requirements into robust system solutions. The role works closely with Clinical Operations, Monitoring, Biostatistics, Clinical Supplies, Data Management, and external IRT vendors, managing system delivery from requirements and design through user acceptance testing, deployment, maintenance, and ongoing support.

The role requires technical expertise in IRT systems and integrations, strong project leadership, attention to detail, and the ability to manage multiple options and risks in parallel while meeting demanding clinical timelines. The manager provides technical guidance and customer support to cross-functional partners, ensures compliance with established processes and applicable SOPs, and maintains appropriate IRT documentation. The role may also contribute to mentoring Clinical Supply Systems Specialists and explore appropriate use of Generative AI and other digital tools within quality, compliance, and data-governance requirements.

The position follows Moderna’s 70/30 work model, with 70% in-office collaboration. The work environment is smoke-free, alcohol-free, and drug-free. The stated salary range is $121,600–$194,500, with potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility and performance.

Requirements

• At least 3–6 years of clinical supply systems experience.
• Bachelor’s degree in a science-based subject.
• IRT subject matter expertise.
• Prior experience demonstrating innovation in integrations between clinical systems such as IRT and EDC in a clinical research environment.
• Understanding of cold-chain distribution and its effect on IRT.
• Creative, capable problem-solving skills.
• Experience establishing and maintaining vendor relationships.
• Working knowledge of ICH, GAMP, FDA, IRB/IEC, and other applicable regulations and guidelines, and demonstrated understanding of clinical research protocol requirements.
• Proficiency with word processing, spreadsheet, database, and presentation software, including Outlook, Word, Excel, PowerPoint, and SharePoint.
• Curiosity about new paths for clinical research, boldness in proposing creative solutions, ability to collaborate with multifunctional teams and partners, and persistence in pursuing successful outcomes.

Nice To Haves

• Advanced degree preferred.
• Prior product ownership experience strongly preferred.
• Experience with forecasting applications and/or IRT product management is an advantage.

Responsibilities

• Autonomously manage IRT systems for assigned programs and studies across the clinical portfolio, including individual studies or a small portfolio of programs and associated studies.
• Lead IRT implementation project management, including requirements gathering, system design, configuration-related coordination, user acceptance testing, implementation, maintenance, and ongoing lifecycle support.
• Work with external IRT vendors on day-to-day delivery and align vendor activities, system milestones, and deliverables with stakeholders, study requirements, and business timelines.
• Gather cross-functional requirements and translate clinical development, supply, and operational needs into detailed IRT system designs.
• Apply IRT and integration expertise to anticipate dependencies and ensure technical solutions support clinical development operations.
• Create UAT test cases and coordinate and oversee user acceptance testing before implementation.
• Oversee and facilitate required signatures and completion of IRT documentation, including preparation of risk assessments and impact assessments.
• Facilitate IRT operational support and data changes with Clinical Operations and Monitoring teams to support study execution and operational goals.
• Provide technical support and customer service to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management under the direction of the Senior Manager.
• Serve as an IRT subject matter expert for other departments, providing technical guidance on system capabilities, dependencies, risks, and potential solutions.
• Coordinate IRT projects, end-user training, meetings, and technical discussions across functions.
• Ensure adherence to established processes and applicable SOPs during IRT system delivery and maintenance.
• Administer, complete, and upload appropriate IRT documentation to the relevant electronic Trial Master File (eTMF).
• Identify delivery risks, pursue multiple options in parallel where needed to maintain timelines, and escalate significant risks or issues to the Senior Manager or Associate Director.
• Communicate delivery status, emerging risks, dependencies, and decisions to leadership and internal stakeholders.
• Contribute to mentoring Clinical Supply Systems Specialists and supporting capability development, as appropriate.
• Apply forecasting applications and/or IRT product management experience where relevant.
• Explore appropriate uses of Generative AI and other digital tools to improve requirements analysis, documentation, test-case development, knowledge retrieval, and workflow efficiency, within quality, compliance, and data-governance requirements.
• Take on assignments that may expand based on experience, technical capabilities, and evolving portfolio needs.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to company plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager