Manager, Clinical Supply Systems

Hiring By - Biostaffic

 BioPharma

Cambridge, Massachusetts - United States

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
The Role:
Moderna is seeking a Manager, Clinical Supplies Systems to oversee and manage IRT systems for Moderna’s growing portfolio of studies and associated internal software systems. This person will be required to work with external IRT vendors (performance and day-to-day operations) to ensure Moderna’s clinical portfolio aligns with internal stakeholders and timelines from business and digital functions (e.g. Program Management, Biostatistics, Informatics Engineering, Data Science and AI). This position will work collaboratively across several planning and operations systems as well as cross-functionally to gather relevant business requirements and utilize the available resources to create the system architecture, support the system design and development, mentor team members, 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.
Here’s What You’ll Do:
  • Manage IRT Systems for Programs and Processes at Moderna
  • Responsible for IRT requirements, user acceptance testing, and management
  • May be responsible for mentoring/leading a team of people dedicated to IRT management and operations
  • Report on key metrics and ensure IRT system health for the duration of the study
  • Discover and gather system requirements needed to support the CDO organization
  • Analyze the system requirements, prototype early-stage solutions, and design IRT systems
  • Rollout new and key growth functionality that will have a high impact and shape the future of the IRT industry
  • Manage user requirements, functional requirements, user acceptance testing, and system delivery
  • Collaborate with the digital teams on the design, development, and delivery of new capabilities
  • Collaborate with the digital teams and external vendors on data integrations; develop best practices for external data integrations
  • Ensure work is done in compliance with all relevant SOPs and regulations
  • Implement industry best practices for clinical supplies planning and operations
  • Collaborate with users on the clinical supply systems implementation so all clinical drug supply needs are met
  • Monitor and track software development lifecycle to ensure smooth adoption
Here’s What You’ll Bring to the Table:
  • At least three to eight years of clinical supply systems experience in a clinical research environment
  • 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
  • Prior biopharmaceutical, pharmaceutical, or chemical manufacturing experience preferred
  • 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
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • 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 modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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 proud to be an equal opportunity workplace and is an affirmative action employer.
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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
]]>

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Cambridge, Massachusetts - United States

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Moderna
Moderna

Current Openings: 0

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.” Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients. We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured. To learn more, visit www.modernatx.com. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀