Senior Specialist Clinical Supply Chain - Operations

Lancesoft; Cambridge (MA); In loco; USD 95.000 - 135.000; Tempo pieno

Descrizione del lavoro

Lancesoft is seeking a Specialist, Clinical Supply Chain - Operations to ensure reliable and compliant execution of clinical supply across protocols. You will manage day-to-day operational activities, ensuring materials reach sites and patients on time while collaborating with Clinical Operations, QA, Regulatory, and external vendors.

Responsibilities include end-to-end supply execution, adherence to timelines, inventory visibility, and IRT system support.

Competenze

• BS degree in Life Sciences or Supply Chain Management required.
• 3+ years of relevant clinical supply chain experience.
• Experience with IRT systems and CMOs.
• Strong understanding of GxP and regulatory expectations.
• Proficient MS Office (Excel, PowerPoint, Visio, Project).

Mansioni

• Lead end-to-end execution of clinical supply activities including packaging, labeling, distribution, inventory management, and study closeout.
• Execute supply activities aligned to protocol timelines (site readiness, patient supply, resupply management).
• Maintain visibility to inventory levels and supply availability across assigned studies.
• Partner with Clinical Operations, QA, and vendors to execute clinical supply plans.
• Support management of IRT systems including system use for supply tracking and resupply execution.
• Identify and mitigate execution risks such as delays and supply constraints.
• Support investigation and documentation of temperature excursions and supply deviations.
• Ensure execution activities are compliant, appropriately documented, and inspection-ready.
• Contribute to process improvements and adoption of new tools and ways of working.
• Maintain accurate documentation including supply plans, trackers, and required clinical supply.

Conoscenze

CMO experience

IRT systems

End-to-end clinical supply chain

GxP

Communication & collaboration

Multi-tasking

Problem solving

Formazione

BS degree in Life Sciences or Supply Chain Management

Strumenti

MS Office

Descrizione del lavoro

Top 3 Must-Have Skills: CMO experience (Contract Manufacturing Organizations), preferably within clinical supply chain operations. Hands-on experience with IRT systems. Strong critical thinking and problem-solving skills. End-to-end clinical supply chain knowledge.

Overview

We are seeking an individual for the role of Specialist, Clinical Supply Chain - Operations. In this position, you will be responsible for the reliable and compliant execution of clinical supply across multiple protocols, ensuring materials are delivered to sites and patients on time. You will focus on day-to-day operational execution activities for assigned protocols, working closely with cross-functional teams including Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors. You will contribute to ensuring uninterrupted supply, managing execution activities, and maintaining visibility to supply status in a dynamic clinical trial environment.

Key Responsibilities

• Lead end-to-end execution of clinical supply activities including packaging, labeling, distribution, inventory management, and study closeout
• Execute supply activities aligned to protocol timelines (e.G., site readiness, patient supply, resupply management)
• Maintain visibility to inventory levels and supply availability across assigned studies
• Partner with Clinical Operations, QA, and vendors to execute clinical supply plans
• Support management of IRT systems including system use for supply tracking and resupply execution
• Identify and escape execution risks such as delays, supply constraints, or deviations
• Support investigation and documentation of temperature excursions and supply deviations
• Ensure execution activities are compliant, appropriately documented, and inspection-ready
• Contribute to process improvements and support adoption of tools and ways of working
• Maintain accurate documentation including supply plans, trackers, and required clinical supply

Qualifications

• BS degree in Life Sciences or Supply Chain Management
• Experience: 3+ years of relevant experience
• Confident Understanding of end to end clinical supply chain activity
• Experience with IRT systems
• Experience with CMOs
• Strong understanding of GxP
• Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)
• Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics
• Strong attention to detail
• Excellent communication and collaboration skills across multiple stakeholders
• Ability to multi-task and manage multiple priorities