Remote Clinical Supply Chain Associate

About the role

We are hiring for a Clinical Supply Chain Associate with 2-5 years of clinical supplies experience. You will have an opportunity to join a growing organization in the biopharmaceutical industry! This position reports directly to our Clinical Supplies Leads. Some travel may be required - up to 15%.

Responsibilities

• Coordinate the day-to-day clinical supply activities across active studies under the direction of the Clinical Supplies Leads
• Maintain accurate, lot- and kit-level traceability records for investigational and auxiliary materials
• Maintain and review study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout
• Track vendor deliverables and shipment status, escalating delays or issues to the Clinical Supply Chain Lead
• Assist in monitoring temperature-controlled shipments and support investigation of excursions or deviations under guidance.
• Maintain vendor contact lists, shipping schedules and standard operating procedures
• Support day-to-day monitoring of the IRT/RTSM system, including kit inventory status and resupply alerts
• Monitor retest and expiry dating of drug supplies and comparators, including collaborating with CMC for stability data updates and overseeing relabeling activities at depots and sites as needed
• Coordinate deliveries from depots to clinical sites to ensure on time and in full delivery of clinical materials
• Ensure all required shipment documentation, Proof of Delivery (POD) documentation forms, and study specific records are complete, accurate, available to the appropriate parties and filed appropriately
• Archive documentation in Trial Master Files as required
• Track and help resolve temperature excursions.

Qualifications

• Bachelor's degree in any field.
• 2-5 years of experience in clinical supplies or logistics in the pharmaceutical/biotechnology or medical device industry
• Exceptional attention to detail, ability to effectively communicate with others, good customer service skills and ability to think critically and solve problems quickly and accurately
• Ideal candidate is organized, has excellent communication skills, sense of urgency and is able to adapt to a rapidly changing environment
• Import/Export experience is required
• Ability to understand timelines and when each tasks need to be done
• Experience in cGMP/GDP and regulatory regulated environment (Pharma, combination product, Biotech, Med device, solutions, solid dosage, semi-solids dosage form, etc.)
• Oracle NetSuite or other ERP supply demand management tools
• Experience with both development, clinical and commercial supplies a plus.

Benefits

• Option to work out of our beautiful Irvine office, complete with onsite gym, pool, table tennis, snacks and drinks, and occasional catered meals.
• Fully remote or hybrid work options.