The Role:
Moderna is seeking a Specialist, Clinical Supply Systems to assist in the operational management of IRT systems and vendors. This position will work collaboratively across several therapeutic area teams as well as cross functionally to gather relevant information and utilize relevant systems to develop and implement IRT systems. The successful candidate will be skilled at understanding the needs of programs with attention to detail with a collaborative outlook, fully support their Clinical Supply Systems Leads, be a self-starter dedicated to excellence in their role with the ability to manage a dynamic workload to meet project timelines.
Here’s What You’ll Do:
Responsible for systems management (namely IRT Systems) to support the clinical supply chain
Responsible for IRT requirements, user acceptance testing, and management
Responsible for facilitation of IRT support, data changes, and working with Clinical Operations and Monitoring to achieve their goals
Responsible for tasks as assigned by Clinical Supply Systems Leads, including but not limited to integrations, test case creation, and risk and impact assessment creation
Adheres to processes as required and ensures compliance to relevant SOPs
Responsible for administration and uploading to a study’s eTMF
Collaborates with CMC, clinical, and project management on schedules
Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements
Here’s What You’ll Bring to the Table:
At least one year of experience in either clinical IRT or clinical supply management experience in a clinical research environment
Bachelor’s degree in a science-based subject (advanced degree preferred)
Understanding of Cold Chain distribution
IRT implementation experience or relevant clinical software
Creative, capable problem-solver
Experience in establishing and maintaining relationships with vendors
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
Demonstrated proficiency with word processing, spreadsheet, database, Smartsheet, 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
At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global 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.
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 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.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. 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. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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