Manager, Clinical Supply Systems

ModernaTX • Princeton, MA

1d • Onsite

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 background
• IRT product management background

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

What This Job Offers

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