Manager, Clinical Supply Systems

Manager, Clinical Supply Systems
Компания: Moderna
Город: Cambridge
**The Role**
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its presence in Cambridge, Massachusetts, home to our global headquarters and a center of mRNA innovation. Working closely with leading universities and research institutions, our Cambridge team advances groundbreaking science that shapes the future of medicine. We welcome talent driven by innovation and committed to improving global health.
This is an opportunity to take autonomous ownership of Interactive Response Technology (IRT) systems supporting Moderna’s growing clinical portfolio, translating complex clinical development and supply requirements into robust, timely system solutions.
Working cross-functionally with Clinical Operations, Monitoring, Biostatistics, Clinical Supplies, Data Management and external IRT vendors, you will lead IRT implementation activities across assigned programs and studies, from requirements and design through user acceptance testing, deployment, maintenance and ongoing support.
As an IRT subject matter expert and individual contributor, you will combine technical depth, rigorous attention to detail and strong project leadership to manage multiple options in parallel, anticipate risk, support data and operational decisions, and deliver high-quality IRT solutions against demanding clinical timelines.
**Here’s What You’ll Do**
* Under the guidance of a Senior Manager or Associate Director, autonomously manage IRT systems for assigned program(s) and studies across Moderna’s clinical portfolio, independently managing individual studies or overseeing a small portfolio of programs and associated studies.
* Lead IRT implementation project management activities, including requirements gathering, system design, configuration-related coordination, user acceptance testing, implementation, maintenance and ongoing system lifecycle support.
* Work closely with external IRT vendors on day-to-day operational delivery, ensuring vendor activities, system milestones and deliverables remain aligned with Moderna stakeholders, clinical study requirements and business timelines.
* Collaborate cross-functionally to gather relevant requirements and translate clinical development, supply and operational needs into detailed and effective IRT system designs.
* Apply deep subject matter expertise in IRT systems and IRT-related integrations, anticipating dependencies and ensuring technical solutions support the needs of a complex clinical development operations organization.
* Create UAT test cases and coordinate and oversee user acceptance testing activities, ensuring systems are appropriately evaluated before implementation.
* Oversee and facilitate required signatures and completion of IRT documentation, including the preparation of risk assessments and impact assessments.
* Facilitate IRT operational support and data changes, working closely with Clinical Operations and Monitoring teams to enable study execution and achieve operational goals.
* Provide exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies and Data Management under the direction of the Senior Manager.
* Serve as an IRT Subject Matter Expert for other Moderna departments, providing technical guidance and helping cross-functional partners understand system capabilities, dependencies, risks and potential solutions.
* Collaborate across functions to schedule and coordinate IRT projects, end-user training, meetings and technical discussions.
* Ensure adherence to established processes and compliance with all relevant SOPs throughout IRT system delivery and maintenance.
* Take responsibility for the administration, completion and upload of appropriate IRT documentation into the relevant electronic Trial Master File (eTMF).
* Proactively identify potential delivery risks, pursue multiple options in parallel where needed to maintain timelines, and escalate significant risks or issues to the Senior Manager or Associate Director as the primary escalation point.
* Operate with a high degree of autonomy while maintaining strong communication with leadership and internal stakeholders on delivery status, emerging risks, dependencies and decisions.
* Bring an imaginative and solutions-oriented approach to IRT delivery, demonstrating close attention to detail, a collaborative outlook, positive leadership and a willingness to contribute wherever needed to ensure successful study execution.
* Contribute, where appropriate, to mentoring Clinical Supply Systems Specialists, sharing IRT expertise and supporting capability development while remaining an individual contributor.
* Apply forecasting applications and/or IRT product management experience where relevant; experience in these areas would be an advantage.
* Explore opportunities to use Generative AI and other digital tools to enhance areas such as requirements analysis, documentation, test-case development, knowledge retrieval and workflow efficiency, while operating within Moderna’s applicable quality, compliance and data-governance requirements.
* Take on assignments that may expand in scope based on your experience, technical capabilities and the evolving needs of Moderna’s clinical portfolio.
**The key Moderna Mindsets you’ll need to succeed in the role:**
* “We pursue options in parallel to make the best choice later.”
* “We act with dynamic range, driving strategy and execution at the same time at every step.”
**Here’s What You’ll Need (Basic Qualifications)**
* 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 **collaborative**ly with multifunctional teams and partners and will be **relentless** in pursuing successful outcomes
**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.
**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.**
* 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