Supervisor II, Clinical Supply

Job Overview

The Clinical Supply Supervisor will be responsible for managing clinical supply logistics and distribution activities for all studies. They will work closely with cross-functional teams including Clinical Operations, Manufacturing, Quality Assurance, and Product Development.

Responsibilities:

• Support the creation, implementation and maintenance of systems for supply management including accountability, returns, deconstruction, and overall reconciliation of supplies.
• Ensure department processes maintain alignment with iso14155 and EUA/FDA requirements.
• Participate in company audits as the Clinical study materials representative.
• Champion continuous improvement activities (Lean Methods) to ensure scalable, efficient, and robust process flows are in place. Objective to constantly pursue team feedback to ensure best practice is implemented and team members are engaged in process improvement culture
• Support Space planning and workflow optimization activities to accommodate future growth
• Provide routing inputs and review project forecast budgets, and monitor team execution to forecast. Remove barriers and resource manage to execute study materials management on time and within budget.
• Review and create protocols, documents, specifications, etc. to ensure quality compliance and traceability are maintained
• Collaborate with GTC personnel to ensure import/export activities are compliant, and work to establish new testing sites and labs in alignment with business growth strategy
• Work with Quality Assurance and Project Managers to review and resolve all shipment related issues, and document nonconformance reports and/or corrective and preventative actions as appropriate
• Generate status reports and communicate updates to necessary department heads as required.
• Supervise clinical research supply team in the day-to-day execution of their job
• Responsible for hiring, career development, and performance management activities for approximately 6+ direct reports
• Support the shipment of investigational product, clinical supplies and specimens in accordance with IATA requirements
• Support additional clinical research or general project or administrative tasks as needed.
• Help create a fun, rewarding and collaborative environment.
  

What your background should look like:

• Bachelors degree in relevant field preferred
• 3+ years of recent Clinical Research or Manufacturing Operations experience in an iso9001, iso13458, or iso14155 regulated environment preferred
• 1+ years of Materials Management, Logistics, Procurement, Supply, and/or assembly related experience preferred
• Meticulous attention to detail and accuracy
• Effective time management, organizational skills and ability to manage multiple tasks
• Excellent verbal and written communication skills required
• Word, Excel, PowerPoint proficient
• Proven ability to collaborate in a team environment and work independently
• Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
• Must be responsible, professional, reliable, and highly motivated

Works Closely With:
Operations Manager, Manager of Clinical Operations, Project Managers, CRAs, CTAs, Clinical Supply Leads, Suppliers, Site Representatives, and Lab Representatives

Competencies