Role Description
Reporting to the Manager, Development Supply Chain, you will support the global distribution of investigational products used in clinical trials. Clinical Supply Chain plays a critical role in ensuring investigational products are delivered to clinical trial sites safely, compliantly, and on time to support patients participating in clinical studies.
As part of the Global Clinical Customer Service (GCCS) team, you will operate as a central coordination point across clinical trial sites, Logistics Service Providers (LSPs), Quality, clinical Planning, and other internal stakeholders to support compliant and efficient clinical trial supply operations. GCCS provides operational oversight, issue resolution, and shipment visibility support for investigational product distribution activities across global clinical studies.
In this role, you will be responsible for distribution complaint management, temperature excursion assessments, investigational product reconciliation support, shipment monitoring activities, and operational support related to investigational product delivery for clinical trials.
Roles & Responsibilities
Under general guidance of the Manager, manage the following key responsibilities:
Distribution Complaint & Issue Resolution
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Manage and resolve distribution complaints related to investigational product shipments supporting global clinical trials.
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Intake and triage Category-1 inquiries from clinical sites, study teams, and internal stakeholders.
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Coordinate cross-functional issue resolution and escalate risks appropriately.
Temperature Excursion Assessment
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Review temperature data for investigational product shipments delivered to clinical trial sites.
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Perform temperature excursion assessments within Quality Management Systems following established procedures.
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Partner with Quality and study teams to support investigations, disposition decisions, and inventory status updates.
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Maintain accurate, complete, and inspection-ready documentation.
Reconciliation & Product Complaint Support
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Support study-level reconciliation activities to ensure accurate investigational product accountability.
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Manage investigational product returns in accordance with procedures and regulatory requirements.
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Support intake, documentation, and coordination of investigational product complaints.
Shipment Management Support
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Monitor investigational product shipments across global depots and Logistics Service Providers.
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Support shipment visibility and order tracking activities within ERP systems.
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Coordinate shipment documentation readiness and support Proof of Receipt (POR) closure activities.
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Identify shipment delays or risks and initiate follow-up or escalation as needed.
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Support KPI tracking, reporting, and operational data analysis.
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Utilize ERP, case management, reporting, and quality systems to support daily activities.
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Support process improvements, automation initiatives, and operational efficiency activities.
Cross-Functional Collaboration & Compliance
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Partner with Planning, Quality, Logistics Service Providers, Clinical Study Teams, and other stakeholders.
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Participate in global, cross-functional meetings and communicate operational risks and status updates proactively.
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Ensure all activities are performed in compliance with GxP, GDP, and applicable regulatory requirements.
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Support deviation documentation, investigations, and CAPA activities as required.
Functional Skills
Must-Have Skills
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Experience in clinical supply chain, pharmaceutical operations, or regulated operational environments.
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Strong problem-solving, issue resolution, and analytical skills.
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Ability to work effectively in a global, matrixed environment.
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Strong service-oriented mindset, responsiveness, and stakeholder support skills.
Good-to-Have Skills
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Experience with temperature-controlled logistics or cold-chain operations.
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Experience with ERP systems (SAP preferred), Salesforce, and the Microsoft suite.
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Experience with quality systems, case management tools, or reporting platforms.
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Knowledge of GxP/GDP and clinical regulatory requirements.
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Experience supporting investigational product distribution or clinical trial operations.
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Experience with process automation or operational improvement initiatives.
Basic Qualifications
Master’s Degree & 4+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR
Bachelor’s Degree & 5+ years of supply chain, logistics, pharmaceutical operations, or related experience
OR
Associate’s Degree & 8+ years of relevant experience
OR
High School Diploma / GED & 10+ years of relevant experience
Professional Competencies
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Strong organizational and stakeholder management skills.
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Results-oriented with strong adherence to timelines and compliance requirements.
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Ability to manage multiple responsibilities in a fast-paced environment.
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Strong attention to detail and documentation accuracy.
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Sound judgment in decision-making and escalation.
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Ability to operate independently while collaborating effectively within a matrixed team environment.
