Manager, Clinical Supply Systems
About The Position
Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies. This person will be required to work with external IRT vendors (day-to-day operations) to ensure Moderna’s clinical portfolio aligns with internal stakeholders and timelines from business. This position will work collaboratively and cross-functionally to gather relevant requirements and utilize the available resources to create the IRT system design, provide subject matter expertise, and ensure expert and on-time IRT system delivery and implementation. The successful candidate is a subject matter expert at IRT-related integrations, imaginative, skilled at understanding the needs of a clinical development operations organization with high attention to detail, a collaborative outlook, a positive leader, above no task, and the ability to pursue multiple options in parallel to meet project timelines 100% of the time. Forecasting applications and IRT product management background are a plus. Managers are expected to independently manage studies or oversee a small portfolio of programs and associated studies, contributing their expertise in IRT system management. They are anticipated to operate autonomously, with the Senior Manager/Associate Director serving as the primary contact for risk mitigation and issue escalation.
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)
- 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 collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes
Nice To Haves
- Forecasting applications and IRT product management background are a plus.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
