Clinical Supply Chain Project Manager

We are looking for a Clinical Supply Chain Project Manager for a 12 month + remote contract. Candidates must sit in either PST or CMT time zones.

This is a w2 remote project. No Corp to Corp.

Will not start until April 1st

Duration – 12 months initially

Must have:

• 3 years - Clinical supply chain
• Forecasting experience
• Clinical Supply Chain system experience – could be a few tools here
• GMP and international best practice experience for MFG processes
• Excellent soft skills and follow up

Preferred - Veeve

Clinical Supply Chain Manager

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

Education/Experience:

• Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable.
• 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.
• Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology – IRT).
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills both in writing and verbally.

Knowledge, Skills and Abilities:

• Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology – IRT).
• Knowledge of global clinical supply regulations (GMP, GCP, GDP), and import / export requirements.
• Experience with supply chain software and IRT systems.
• Strong understanding of clinical trial logistics and inventory management.
• Excellent organizational, problem-solving, and multitasking abilities.
• Strong communication and collaboration skills.
• Detail-oriented with the ability to work in a fast-paced environment.