Clinical Supply Chain Specialist
Healthcare
Job Description
Job Description
- Role: Clinical Supply Specialist
- Client: Biotech
- Job ID: 326
- Location: Alameda, CA
- Duration: 1 Year
- Pay/Bill Details: $35/hr (contractor must be on W2 with TechData).
Shift: Regular Shift (8:00 AM – 5:00 PM)
Job Summary The Clinical Supply Specialist supports multiple clinical programs in close coordination with Clinical Supplies project leads. This role independently coordinates clinical supply activities for study development programs, including protocol reviews, clinical label design, packaging and labeling requests, depot and site shipment management, inventory monitoring, and supply planning/forecasting.
Essential Duties & Responsibilities
- Supply Planning & Execution: Assist with clinical packaging projects, CMO scheduling oversight, label production, and clinical trial supply packaging.
- Logistics & Inventory: Coordinate and track drug shipments, monitor inventory across depots, sites, and distribution points, and perform drug accountability.
- Vendor & Cross-Functional Coordination: Serve as the primary contact for third-party storage, distribution, and packaging vendors. Partner with Quality Assurance and Regulatory Affairs to ensure compliant product release.
- Compliance & Labeling: Design and review label text to satisfy product requirements and US/international regulations. Maintain traceable documentation supporting GxP activities.
- Team Representation: Represent the clinical supplies function during trial team meetings, communicating plans and timelines to internal and external partners using relevant software and IT systems.
- Special Projects: Opportunity to manage assigned clinical projects as needed.
Job Complexity & Leadership
- Complexity: Evaluates diverse and complex issues requiring in-depth analysis of variable factors. Exercises judgment in selecting methods and evaluation criteria. Networks with key external contacts.
- Supervisory Responsibilities: None.
Qualifications
- Education:
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- Bachelor’s degree with 3+ years of related experience, OR
- Master’s degree with 1+ year of related experience, OR
- Equivalent combination of education and experience.
- Relevant professional certification is a plus.
- Experience: Typically requires a minimum of 7 years of combined professional experience and/or education.
- Knowledge & Skills:
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- Demonstrated background in clinical supply planning, labeling, packaging, and distribution.
- Experience working with Contract Manufacturing Organizations (CMOs) strongly preferred.
- Working knowledge of GMP, GCP, and GLP regulations, including GMP batch record processes.
- Familiarity with Interactive Voice/Web Response Systems (IXRS/IWRS) used in clinical studies.
- Strong project management, communication, and creative problem-solving abilities in a fast-paced environment.
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