Manager, Clinical Supply Systems

The Role:
Moderna is seeking a Manager Clinical Supplies Systems to oversee and manage IRT systems for Modernas growing portfolio of studies. This person will be required to work with external IRT vendors (day-to-day operations) to ensure Modernas 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.

Heres What Youll 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 individuals level of experience

Heres What Youll Bring to the Table:

• At least three to six years of clinical supply systems experience

• Bachelors 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. Thats why our benefits and well-being resources are designed to support youat work at home and everywhere in between.

• 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

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 to learn more about our current opportunities.

Our Working Model

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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

Were 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 .

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