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Manager, Clinical Supply Systems

Moderna
18 hours ago
Full-time
On-site
Cambridge, MA, United States
$121,600 - $194,500 USD yearly
Indeed

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 …

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