Associate Manager, Clinical Supply Chain
New
J
JobgetherClinical supply chain
Full-time remote opportunity based in the United States.Full-TimeManager
Salary$91,000–$126,000, depending on qualifications, experience, skills, and work location.
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Job Details
- Experience
- At least four years of progressively responsible supply chain experience, preferably within the biotechnology, pharmaceutical, or contract research organization (CRO) industry.
- Required Skills
- Microsoft Excel
Requirements
- Bachelor's or master's degree in Business Administration, Operations Management, Supply Chain Management, or a related field.
- At least four years of progressively responsible supply chain experience; biotechnology, pharmaceutical, or CRO experience is preferred.
- Understanding of clinical trial supply planning, investigational product distribution, inventory management, labeling, packaging, and production scheduling.
- Working knowledge of current Good Manufacturing Practice (cGMP) requirements and compliant clinical supply chain processes.
- Experience developing supply plans, coordinating production schedules, managing inventory levels, monitoring expiry dates, and ensuring product availability.
- Familiarity with interactive response technology (IRT), including supply strategies, configuration parameters, user acceptance testing, and system-based supply management.
- Ability to coordinate with contract manufacturing organizations, packaging providers, depots, and distribution partners.
- Understanding of investigations, root cause analysis, corrective and preventive actions, and regulatory requirements for clinical trial materials.
- Experience coordinating shipments, tracking materials, managing import documentation, and maintaining operational records.
- Strong working knowledge of Microsoft Word, Excel, and Outlook.
Responsibilities
- Represent Clinical Supply Chain on Clinical Study Teams and collaborate with internal stakeholders.
- Develop clinical supply and inventory plans, align them with study demand, and establish production schedules.
- Manage GMP inventory, maintain accurate inventory reports, monitor expiry dates, and ensure drug accountability.
- Coordinate labeling and packaging activities with contract manufacturing organizations and distribution vendors.
- Investigate supply chain exceptions, identify root causes, and implement corrective and preventive actions.
- Review label text and proofs for compliance with regulations, product specifications, and study protocols.
- Support IRT user acceptance testing, develop supply strategies and allocation parameters, and oversee ongoing supply activities.
- Coordinate and track shipments to contract manufacturing organizations, depots, and external vendors; maintain and monitor import licenses.
- Identify supply risks and disruptions, develop mitigation plans, and contribute to process improvement projects.
- Develop, review, and update SOPs and process documentation, and monitor supporting staff deliverables.
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