Clinical Supplies Specialist I

Job Title: Clinical Supplies Specialist I
Location: Alameda, CA 100% Onsite
Compensation: $27-32/hr
Type: Contract

Responsibilities

• Support multiple clinical programs by coordinating clinical supply activities in collaboration with Clinical Supplies project leads.
• Review clinical study protocols and design clinical labels to ensure compliance and accuracy.
• Prepare packaging and labeling requests, manage depot and site shipments, and monitor study drug inventory levels.
• Assist in supply planning and forecasting to optimize clinical trial logistics.
• Oversee the coordination of clinical packaging projects, including oversight of production schedules and label production.
• Track and coordinate drug shipments, monitor inventory at depots, sites, and distribution points.
• Perform drug accountability with depots, clinical sites, and sponsor inventories.
• Manage relationships with third-party storage, distribution, and packaging vendors.
• Maintain traceable documentation supporting GXP activities.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure labeling and release for shipments meet compliance standards.
• Design and review label text to meet product requirements and regulatory standards.
• Represent clinical supplies in team meetings, communicating plans and timelines to stakeholders.
• Utilize relevant software and IT systems for project management activities.

Requirements

• BS/BA degree in a related discipline with at least three years of related experience, or MS/MA degree with at least one year of related experience, or an equivalent combination of education and experience.
• Experience with clinical supply planning, labeling, packaging, and distribution.
• Experience with contract manufacturing companies preferred.
• Knowledge of GMP batch record development, review, and approval processes.
• Understanding of GMP/GCP/GLP regulations.
• Strong project management and communication skills.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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