Manager, Clinical Supply Systems

Moderna • Princeton, NJ

2d • $121,600 - $194,500 • Hybrid

About The Position

The Manager, Clinical Supply Systems will take autonomous ownership of Interactive Response Technology (IRT) systems supporting Moderna’s clinical portfolio. The role translates clinical development, supply and operational requirements into robust, timely IRT solutions and works across Clinical Operations, Monitoring, Biostatistics, Clinical Supplies, Data Management and external IRT vendors. As an individual contributor and IRT subject matter expert, the manager leads implementation across assigned programs and studies, from requirements and design through user acceptance testing, deployment, maintenance and ongoing support. The role manages multiple options in parallel, anticipates risks and dependencies, supports operational and data decisions, and delivers high-quality systems on demanding clinical timelines under the guidance of a Senior Manager or Associate Director.

The position is based on Moderna’s in-person 70/30 work model, with 70% in-office collaboration. The working environment is smoke-free, alcohol-free and drug-free. The role may expand in scope according to experience, technical capabilities and the evolving needs of Moderna’s clinical portfolio.

Requirements

• At least three to six 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.
• Ability to work collaboratively with multifunctional teams and partners, propose creative solutions and pursue successful outcomes.
• Ability to operate autonomously while maintaining strong communication with leadership and stakeholders.

Nice To Haves

• Advanced degree.
• Prior product ownership experience (strongly preferred).
• Experience with forecasting applications and/or IRT product management.

Responsibilities

• Autonomously manage IRT systems for assigned programs and studies, including individual studies or a small portfolio of programs and associated studies.
• Lead IRT implementation project management, including requirements gathering, system design, configuration coordination, user acceptance testing, implementation, maintenance and lifecycle support.
• Work with external IRT vendors on operational delivery and keep activities, milestones and deliverables aligned with stakeholders, study requirements and 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.
• Facilitate required signatures and completion of IRT documentation, including risk and impact assessments.
• Facilitate IRT operational support and data changes with Clinical Operations and Monitoring teams.
• Provide technical support and customer service to Clinical Operations, Biostatistics, Clinical Supplies and Data Management.
• Serve as an IRT subject matter expert for other departments, providing technical guidance about 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 relevant SOPs during IRT delivery and maintenance.
• Administer, complete and upload appropriate IRT documentation to the relevant electronic Trial Master File (eTMF).
• Identify delivery risks, pursue options in parallel when needed to maintain timelines, and escalate significant risks or issues to the Senior Manager or Associate Director.
• Communicate delivery status, risks, dependencies and decisions to leadership and internal stakeholders.
• Contribute to mentoring Clinical Supply Systems Specialists and developing their capabilities while remaining an individual contributor.
• Apply forecasting applications and/or IRT product management experience where relevant.
• Explore Generative AI and other digital tools to improve requirements analysis, documentation, test-case development, knowledge retrieval and workflow efficiency while following quality, compliance and data-governance requirements.
• Take on assignments that may expand in scope as the portfolio and role needs evolve.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness and mental health support.
• Family planning benefits, including fertility, adoption and surrogacy support.
• 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 plan eligibility and individual performance.

What This Job Offers

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