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Moderna

Develops mRNA-based medicines for health

Manager – Clinical Supply Systems

Clinical Research OperationsPosted on Nov 9
Full-time

About the Job

Requirements

  • At least three to six years of clinical supply systems experience.
  • A bachelor's degree in a science-based subject is required.
  • Demonstrated innovation in integrations between clinical systems such as IRT and EDC in a clinical research environment.
  • Understanding of cold chain distribution and its effect on IRT.
  • Subject matter expertise in IRT systems.
  • Experience establishing and maintaining vendor relationships.
  • Working knowledge of ICH, GAMP, FDA, IRB/IEC, other applicable regulations and guidelines, and clinical research protocol requirements.
  • Proficiency with word processing, spreadsheets, databases, presentation software, and Microsoft Office applications including Outlook, Word, Excel, PowerPoint, and SharePoint.
  • Explore Generative AI and other digital tools within applicable quality, compliance, and data-governance requirements.

Responsibilities

  • Autonomously manage IRT systems for assigned programs and studies across the clinical portfolio, including individual studies or 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 lifecycle support.
  • Coordinate day-to-day operational delivery with external IRT vendors and ensure vendor activities, system milestones, and deliverables align with stakeholders, study requirements, and business timelines.
  • Gather requirements cross-functionally and translate clinical development, supply, and operational needs into IRT system designs.
  • Apply IRT and integration expertise to anticipate dependencies and ensure technical solutions support clinical development operations.
  • Create user acceptance testing cases and coordinate and oversee testing before implementation.
  • Facilitate signatures and completion of IRT documentation, including risk assessments and impact assessments.
  • Facilitate IRT operational support and data changes with Clinical Operations and Monitoring teams to support study execution and operational goals.
  • Provide 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 departments, providing technical guidance on system capabilities, dependencies, risks, and potential solutions.
  • Schedule and coordinate IRT projects, end-user training, meetings, and technical discussions across functions.
  • Ensure adherence to established processes and relevant SOPs throughout IRT system delivery and maintenance.
  • Administer, complete, and upload appropriate IRT documentation to the relevant electronic Trial Master File.
  • Identify delivery risks, pursue parallel options as needed to maintain timelines, and escalate significant risks or issues to the Senior Manager or Associate Director.
  • Communicate delivery status, emerging risks, dependencies, and decisions to leadership and internal stakeholders.
  • Contribute to mentoring Clinical Supply Systems Specialists and supporting capability development while remaining an individual contributor.
  • Take on assignments that may expand in scope based on experience, technical capabilities, and evolving portfolio needs.

Desired Qualifications

  • Advanced degree.
  • Prior product ownership experience.
  • Experience with forecasting applications and/or IRT product management.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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