Sr. Specialist, Kitting Operations

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:

• 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 f