The Role:
The Sr. Specialist, Kitting Operations will support clinical kit logistics for clinical trials, ensuring that kit specifications, ordering, and resupply management align with study needs. This role will execute day-to-day operational tasks for kitting processes, focusing on inventory management, tracking, and reporting under established protocols. The Sr. Specialist will work closely with internal teams to maintain operational efficiency and support study timelines.
Here’s What You’ll Do:
Execute established kitting processes for clinical trials, including kit specification review, order placement, resupply management, and operational tracking.
Support inventory management by maintaining kit stock levels, ensuring adherence to established inventory thresholds, and flagging potential shortages.
Monitor data and report on inventory usage, resupply status, and kit expirations using predefined templates and procedures.
Assist in routine kit-related reporting to update stakeholders on inventory status, expirations, and supply needs, focusing on procedural compliance.
Collaborate within the immediate team to address basic logistical issues related to kit supply and distribution, seeking guidance for more complex challenges.
Support standard documentation practices to ensure kit specifications and processes are compliant with study protocols and regulatory requirements.
Study Startup Support:
Attend specification meetings to assist with documentation and kit requirements according to provided guidelines, ensuring alignment with protocol standards.
Update kit tracking information in Smartsheet under supervisor guidance, ensuring that data remains accurate for reporting purposes.
Operational Execution & Process Management:
Manage routine kit orders (initial and resupply) following predefined guidelines to maintain supply levels, with oversight from senior team members as needed.
Support kit reviews to monitor stock levels, focusing on basic compliance and reporting requirements to prevent overstocking.
Assist in resupply processes by following established thresholds and procedural limits for each kit type.
Study Maintenance & Reporting:
Prepare and distribute regular reports based on defined templates, providing updates on kit usage, expirations, and any resupply needs.
Track and manage routine kit orders within set limits, escalating any issues with stockouts or delays to management.
Cross-functional Collaboration:
Coordinate with clinical operations and supply chain teams for routine kit management needs, with limited external interaction.
Act as an internal point of contact for basic kit-related inquiries, escalating complex issues to supervisors.
Documentation & Compliance:
Conduct regular document reviews to ensure kit specifications are accurate and align with established company standards.
Support maintenance of kitting operations documentation to meet regulatory and procedural requirements, under direct supervision.
Here’s What You’ll Need:
Bachelor’s degree or equivalent experience in a relevant field (e.g., supply chain, logistics) is preferred.
Basic understanding of GxP guidelines and compliance standards for clinical trial materials
Proficiency with Smartsheet, Excel, and Word for basic data tracking and reporting.
Strong organizational skills with attention to detail for kit tracking and reporting in line with standard processes.
Effective problem-solving skills for routine logistical issues, with guidance for complex challenges.
Strong communication skills for collaboration within the immediate team and basic coordination with related functions.
This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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.
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.
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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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