Clinical Supply Chain Consultant

** W2 only - Not available for C2C/1099 consulting **

Target Start Date:

April 1st

Overview

Responsible for the global supply and distribution of Investigational Medicinal Product (IMP) for our clients’ ongoing clinical trials. The ideal candidate is a self-starter with the ability to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth.

Job Functions/Responsibilities:

• Review clinical protocols to understand study requirements and translate them into demand forecasts for clinical trial materials, including investigational drugs and ancillaries.
• Assist in supply planning, ensuring alignment with study timelines and minimizing waste.
• Coordinate with vendors, internal teams, and stakeholders to manage supply needs effectively.
• Coordinate packaging and labeling activities, ensuring adherence to Good Manufacturing Practices (GMP) and international standards.
• Review labels, pre- and post-production records, Certificates of Analysis, for clinical packaging and labeling.
• Oversee the distribution of Investigational Medicinal Product (IMP) to depots and investigational sites.
• Manage import/export activities, ensuring compliance with global shipping regulations.
• Monitor shipment tracking and resolve any delays or issues. Gather and maintain proof of delivery documents for all IMP shipments, ensuring traceability and accountability.
• Maintain accurate inventory records and track supply levels across multiple studies.
• Work with Interactive Response Technology (IRT) system(s) to manage stock levels, allocations, and participate in UAT testing.
• Manage drug accountability, reconciliation, and return processes at study completion and filling documents for eTMF.
• Ensure all clinical supply activities comply with Good Clinical Practice (GCP), GMP, and global regulatory requirements.
• Support the development and maintenance of Standard Operating Procedures (SOPs) and clinical supply documentation.
• Manage deviations, change controls, and audits related to clinical supplies.
• Work closely with Clinical Operations, Regulatory Affairs, Quality Assurance, and vendors to coordinate supply chain activities.
• Assist in vendor management, including contract negotiations and performance tracking.
• Support budget planning and cost tracking for clinical supply activities.

Qualifications:

• 3-5 years of experience in clinical supply chain, pharmaceutical logistics, or a related industry
• Skilled in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products
• Knowledge of global clinical supply regulations (GMP, GCP, GDP), and import / export requirements
• Experienced with Clinical Supply Chain systems for inventory management and IRT systems
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects
• Detail-oriented with the ability to work in a fast-paced environment.
• Excellent communication skills both in writing and verbally.

Education:

Bachelor’s degree in a relevant field (Biology, Pharmacy, etc.); Advanced degree is desirable