FSP IRT Project Manager - Global Clinical Supplies at Thermo Fisher Scientific

Role Summary

• The IRT Project Manager will provide portfolio-level IRT project management oversight across multiple clinical studies and IRT platforms within an FSP delivery model. The role supports both standard IRT Managed Services and studies requiring enhanced or supplemental IRT oversight. The IRTPM will partner closely with Global Clinical Supplies, Clinical Operations, sponsors, and IRT vendors to ensure effective IRT execution, supply continuity, and alignment with study needs. Hands-on experience with the 4G Clinical IRT platform is required to support studies utilizing 4G and to address scenarios where additional operational involvement is needed beyond standard managed services.

Key Responsibilities

IRT Project Management and Portfolio Oversight

• Provide project management oversight for IRT activities across a portfolio of clinical trials and IRT platforms.
• Serve as the primary IRT point of contact for assigned studies, ensuring alignment between sponsor expectations, managed services scope, and FSP responsibilities.
• Support governance, documentation, and adherence to defined RACI models across IRT engagements.

IRT Managed Services Interface

• Act as the liaison between study teams and IRT Managed Services to ensure services are delivered in line with contractual scope.
• Monitor IRT Managed Services performance, risks, and deliverables across assigned studies.
• Identify gaps between managed services scope and study needs and escalate or mitigate appropriately.

Supply Strategy and Operational Alignment

• Collaborate with Global Clinical Supplies PMs on threshold strategies, resupply planning, and enrollment-driven forecasting as needed.
• Support inventory, expiry, and shipment oversight in coordination with GCS PMs, particularly when IRT activities directly impact supply continuity.
• Assist with exception management, including manual shipments and depot-to-depot transfers, when required.

Cross-Functional and Vendor Coordination

• Coordinate across sponsors, IRT vendors, depots, packaging partners, and internal teams to ensure seamless execution.
• Support studies with complex communication matrices or limited sponsor-side IRT resources.
• Drive issue escalation and resolution across functional and vendor boundaries.

Risk Management and Continuous Improvement

• Proactively identify IRT and supply-related risks across the portfolio and support mitigation planning.
• Contribute to process improvements, lessons learned, and best practices related to IRT and supply integration.
• Support internal planning related to workload, resourcing, and financial considerations for IRT activities.

Enhanced IRT and 4G-Specific Support

• Apply hands-on knowledge of the 4G Clinical IRT platform to support studies requiring deeper operational involvement.
• Support or perform ongoing 4G configuration oversight, system monitoring, and operational adjustments when required by study complexity or sponsor needs.
• Provide subject matter expertise for 4G-related troubleshooting, issue resolution, and vendor interactions.