Manager, Clinical Supply Systems
Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This role requires collaboration with external IRT vendors to align Moderna’s clinical portfolio with internal stakeholders and timelines. The successful candidate will work cross-functionally to gather requirements, design IRT systems, provide subject matter expertise, and ensure on-time delivery and implementation.
About the role
The Manager, Clinical Supplies Systems is a subject matter expert in IRT-related integrations, responsible for independently managing studies or overseeing a small portfolio of programs. This role operates autonomously, with the Senior Manager/Associate Director serving as the primary contact for risk mitigation and issue escalation. A background in forecasting applications and IRT product management is a plus.
Responsibilities
- Manage IRT Systems for assigned program(s) and studies at Moderna with autonomy, under the guidance of a Senior Manager or Associate Director.
- Oversee IRT implementation project management, including requirements gathering, design, user acceptance testing (UAT), and maintenance.
- Contribute to mentoring Clinical Supply Systems Specialists.
- Facilitate IRT support, data changes, and collaboration with Clinical Operations and Monitoring to achieve goals.
- Create UAT test cases, oversee documentation signatures, and perform risk and impact assessments.
- Adhere to processes and ensure compliance with relevant SOPs.
- Administer and upload documentation to appropriate eTMF systems.
- Collaborate cross-functionally to schedule projects, end-user training, meetings, and discussions.
- Deliver exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management.
- Serve as the IRT Subject Matter Expert to other Moderna departments.
- Task assignments may expand in scope based on the individual's level of experience.
Requirements
- At least three to six years of clinical supply systems experience.
- Bachelor’s degree in a science-based subject (advanced degree preferred).
- Prior Product Ownership Experience (strongly preferred).
- Demonstrated innovation in integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment.
- Understanding of Cold Chain distribution and its effect on IRT.
- IRT Subject Matter Expertise.
- Creative, capable problem-solver with a collaborative mindset.
- Experience in establishing and maintaining relationships with vendors.
- Working knowledge of ICH, GAMP, FDA, IRB/IEC, and other applicable regulations/guidelines.
- Demonstrated understanding of clinical research protocol requirements.
- Proficiency with MS Office tools (Outlook, Word, Excel, PowerPoint, SharePoint).
- Curiosity in exploring new paths for clinical research, boldness in proposing creative solutions, and relentless pursuit of successful outcomes.
Benefits
- Competitive healthcare, plus voluntary benefit programs to support unique needs.
- Holistic well-being support, including fitness, mindfulness, and mental health resources.
- 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 to help plan for the future.
- Location-specific perks and extras.
Pay
The salary range for this role is $121,600.00 - $194,500.00. An individual’s position within the salary range will be based on factors including competencies, education, qualifications, certifications, experience, skills, performance, and business needs. The successful candidate may also be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
Schedule
Moderna embraces a 70/30 work model, with 70% in-office collaboration to foster innovation, teamwork, and direct mentorship.