Specialist, Clinical Supply

Role Summary

Moderna is seeking a Specialist, Clinical Supply Systems to assist in the operational management of IRT systems and vendors. This position will work collaboratively across several therapeutic area teams as well as cross-functionally to gather relevant information and utilize relevant systems to develop and implement IRT systems. The successful candidate will be skilled at understanding the needs of programs with attention to detail, with a collaborative outlook, fully support their Clinical Supply Systems Leads, and be a self-starter dedicated to excellence in their role with the ability to manage a dynamic workload to meet project timelines.

Responsibilities

• Responsible for systems management (namely IRT Systems) to support the clinical supply chain
• Responsible for IRT requirements, user acceptance testing, and management
• Responsible for facilitation of IRT support, data changes, and working with Clinical Operations and Monitoring to achieve their goals
• Responsible for tasks as assigned by Clinical Supply Systems Leads, including but not limited to integrations, test case creation, and risk and impact assessment creation
• Adheres to processes as required and ensures compliance to relevant SOPs
• Responsible for administration and uploading to a study’s eTMF
• Collaborates with CMC, clinical, and project management on schedules
• Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements

Qualifications

• At least one year of experience in either clinical IRT or clinical supply management experience in a clinical research environment
• Understanding of Cold Chain distribution
• IRT implementation experience or relevant clinical software
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• Demonstrated proficiency with word processing, spreadsheet, database, Smartsheet, 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
• For this role, candidate must already hold work authorization in the US and be able to maintain that status without the need for future sponsorship

Education

• Bachelor’s degree in a science-based subject (advanced degree preferred)