Quality Control and Administration Manager, Clinical Supplies Systems - Randstad Life Sciences US : Job Details

ON-SITE IN Cambridge, MA OR Princeton, NJ

12 months with the potential to convert

We are seeking a detail-oriented professional to manage the SOW and Change Order process with three Interactive Response Technology (IRT) vendors.

This role is heavily focused on finance and inspection readiness, requiring expertise in vendor relationship management and invoice lifecycle oversight, including escalation and resolution of invoicing issues.

While no prior IRT operations experience is required, the ideal candidate should have a background in Clinical Operations, Outsourcing, or Business Development and be capable of managing documents efficiently, identifying associations, and transferring data into spreadsheets.

This position involves repetitive tasks requiring accuracy, as well as a smaller component (10-15%) dedicated to reviewing and updating documents.

Job Summary

Seeking a Quality Control and Administration Manager, Clinical Supplies Systems to perform quality control on documentation and financial-related administration. This person will be required to work with external IRT vendors (day-to-day operations and leadership capacity) to ensure Moderna's IRT systems align with internal stakeholders and timelines from business. This position will work collaboratively and cross-functionally to review documentation prior to upload to eTMF and work with external vendors on processing SOWs, COs, and Invoicing. The successful candidate is a subject matter expert at IRT-related finance, ability to review documentation with a keen eye, 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.

Job Responsibilities

• Ensure all operational documents are complete, accurate, and compliant with internal standards.
• Verify proper signatures and oversight are obtained at each step of the process.
• Process Statements of Work (SOWs), Change Orders (COs), and invoices with precision
• Maintain a state of 100% financial reconciliation and ensure on-time processing of invoices
• Collaborate with contracts and procurement teams to ensure timely processing of COs and SOWs
• Address and resolve any discrepancies or delays in contract processing
• Responsible for administration and uploading documentation to appropriate eTMF
• Perform routine budget reconciliations to ensure financial accuracy
• Prepare and present detailed financial reports to the Director of IRT
• Task assignments may expand in scope based on the individual's level of experience
• May be asked to participate in internal audits or external inspections

Education & Qualifications

• At least five to eight years of financial reporting experience
• Bachelor's degree in a science-based or financial-based subject
• IRT Subject Matter Expertise
• 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