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Cambridge, Massachusetts, United States
Hybrid
The Role:
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.
Here’s What You’ll Do:
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
Here’s What You’ll Bring to the Table:
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
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
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