Clinical Supply chain Specialist

Description:

• Candidates will, under limited supervision and in compliance with clinical regulatory requirements, partner with key stakeholders to manage shipments of clinical drug product to clinical sites, globally.

Key Responsibilities and Activities

General:

• Provide distribution support to Global Supply Planners and Logistics Service Providers
• Partner with clinical site staff and Amgen Quality to document, investigate, and communicate decisions concerning distribution complaints.

Sales Order Management:

• Create and manage Clinical Drug Shipments in an ERP system
• Generate customs invoices
• Track and trace shipments
• Perform reconciliation tasks, including the closure of Proof of Receipt (POR)

Temperature Data Review and Assessment:

• Review the temperature data from shipments to clinical sites
• Assess temperature excursion events and partner with Quality personnel to determine a usage decision
• Customer facing communications with study managers and pharmacy staff
• Capture key performance indicators (KPI), discuss trends, and support corrective actions

Other activities:

• Participate in international, cross functional meetings
• Support and manage the reconciliation and return of investigational products
• Support projects and initiatives that improve our distribution capabilities

Technical skills:

• SAP knowledge (or other relevant ERP systems)
• Good MS suite skills, with an emphasis on Outlook and Teams
• Experience with Quality Management Tracking Systems (QMTS)
• Smartsheet and SharePoint knowledge
• General knowledge of clinical supply chain management

Competencies:

• Customer focused and service oriented
• Results oriented, with a strong adherence to timelines
• Ability to handle multiple responsibilities and priorities simultaneously in a dynamic environment
• Accuracy and attention to detail
• Process-oriented
• Excellent communication skills (both written and verbal)
• Ability to interface effectively at all levels with international peers and customers
• Applies relevant experience and utilizes sound judgment to make science-based decisions
• Resolve issues while adhering to defined options or standard protocols
• Anticipate problems and recognize when to escalate issues
• Set priorities within general guidelines
• Ability to operate in a team as well as a strong matrix environment
• Analytical skills
• Quality minded