Clinical Supplies Specialist I

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.

Benefits

• Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans
• Participation in a 401(k) plan

Pay

$27-32/hr

Schedule

100% Onsite