Note: The job is a remote job and is open to candidates in USA. Moderna is a biotechnology company building an mRNA technology platform to reimagine how medicines are created and delivered. The Manager, Clinical Supply Systems will independently manage IRT systems for assigned clinical programs and studies, coordinating with vendors and cross-functional stakeholders on requirements, design, implementation, testing, maintenance, documentation, and support.
Responsibilities
- Under the guidance of a Senior Manager or Associate Director, manage IRT Systems for assigned program(s) and studies at Moderna with autonomy
- Responsible for IRT implementation project management, IRT requirements and design, user acceptance testing, and maintenance
- May contribute to mentoring Clinical Supply Systems Specialists
- Responsible for facilitation of IRT support, data changes, and working with Clinical Operations and Monitoring to achieve their goals
- Responsible for UAT test case creation, oversee and facilitate signatures on documentation, and risk and impact assessment creation, etc
- Adheres to processes and ensure compliance to relevant SOPs
- Responsible for administration and uploading documentation to appropriate eTMF
- Collaborates 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 under the directive of the Senior Manager
- Serve as IRT Subject Matter Expert to other Moderna departments
- Task assignments may expand in scope based on the individual's level of experience
Skills
- At least three to six years of clinical supply systems experience
- Prior demonstration of innovation as it relates to integrations between clinical systems (IRT, EDC, etc.) in a clinical research environment
- Understanding of Cold Chain distribution and the effect on IRT
- IRT Subject Matter Expertise
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with vendors
- Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
- Successful candidate will be **curious** in exploring new path for clinical research, **bold** in proposing **creative** solutions and ideas. Will work **collaborative**ly with multifunctional teams and partners and will be **relentless** in pursuing successful outcomes
- Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position
- Bachelor's degree in a science-based subject (advanced degree preferred)
- Prior Product Ownership Experience (strongly preferred)
Benefits
- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to 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 investments to help you plan for the future
- Location-specific perks and extras
- The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
- A 70/30 work model with 70% in-office collaboration
Company Overview