Clinical Supplies Specialist I

Joulé; Alameda (CA); Sur place; USD 37 195 - 44 083; Plein temps

Résumé du poste

System One is seeking a Clinical Supplies Specialist I in Alameda, CA, for a 100% onsite contract role. You will coordinate clinical supply activities across programs, design labels, manage inventory, and support shipments to sites and depots.

Responsibilities include packaging coordination, drug accountability, and collaboration with QA/Regulatory to ensure compliance. Strong project management and communication skills are required.

Qualifications

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

Responsabilités

• Coordinate clinical supply activities with project leads.
• Review study protocols and design compliant clinical labels.
• Prepare packaging requests and manage shipments and inventory.
• Assist in supply planning and forecasting for trial logistics.
• Oversee packaging projects and production schedules.
• Track drug shipments and monitor depot/site inventories.
• Collaborate with QA and Regulatory to ensure labeling and release.
• Represent the clinical supplies team in meetings and communicate plans.
• Utilize IT systems for project management.

Connaissances

Project management

Communication

Formation

Bachelor's degree in a related discipline

Master's degree in a related discipline

Description du poste

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.
• 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 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.