Senior Clinical Trial Supplies Associate – Client Dedicated

• Monitor clinical supply inventory levels, trends, and potential supply risks

• Support supply forecasting, metrics reporting, and inventory tracking activities

• Process requisitions and coordinate procurement of comparator drugs and ancillary supplies

• Coordinate clinical supply shipments, depot transfers, and site return logistics

• Track shipment delivery schedules and assist with temperature excursion investigations and resolution

• Maintain study documentation, including Expected Document Lists (EDLs), comparator records, and Electronic Trial Master File (eTMF) documentation

• Support QA/QP release requests, inspection readiness activities, and pack-and-label reconciliation processes

• Assist with Interactive Response Technology (IRT) activities, including user access management, alert monitoring, and User Acceptance Testing (UAT)

• Conduct product compatibility research and maintain related data in approved databases and tracking tools

• Manage clinical supply system records, shared mailboxes, and documentation uploads within Veeva

• Operate independently with minimal day-to-day oversight and may coordinate activities of other Clinical Trial Supplies Associates

• Bachelor’s Degree (or equivalent) level of education, preferably in a related field or focused on life sciences
• 2+ years of experience in a contract research organization (CRO), pharmaceutical, or biotechnology company
• Strong knowledge of Good Clinical Practice, ICH guidelines, Good Manufacturing Practice, and other applicable regulatory requirements
• High level of competency in English language
• Ability to perform several tasks simultaneously to meet deadlines
• Self-motivation and ability to work independently
• High proficiency with MS Office Applications
• Ability to travel as necessary (up to 10%)

Demonstrates expertise in clinical supply management, including inventory tracking, procurement coordination, and compliance with regulatory standards. Proficient in utilizing tools like Veeva and MS Office to support clinical trial operations and documentation.

• Clinical Supply Management
• Good Clinical Practice
• Inventory Tracking
• Veeva Proficiency
• Procurement Coordination

• Inventory Tracking
• Procurement Coordination
• Regulatory Compliance
• Data Management
• Temperature Excursion Investigation
• User Acceptance Testing
• Metrics Reporting Document Management
• Supply Forecasting
• Product Compatibility Research

• Self-Motivation
• Ability to Work Independently
• Multitasking
• Deadline Management

• Contract Research Organization
• Pharmaceutical
• Biotechnology
• ICH Guidelines
• Good Manufacturing Practice

• Veeva
• MS Office Applications
• Interactive Response Technology