Clinical Supply Specialist (Contract)

Responsibilities

• Supports the development and execution of Clinical Supply strategies for all 4DMT’s Phase 1/2/3 investigational drug products and ancillaries
• Coordinates and tracks bulk drug orders to ensure adherence to pre-defined supply and resupply timelines
• Maintains site inventory on a daily basis; coordinates and tracks drug shipments to ensure uninterrupted supply
• Supports drug product inventory management and distribution in partnership with 4DMT’s clinical partners; evaluates drug utilization versus forecast considering country requirements and logistical timeline
• Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout
• Tracks and resolves study and depot level temperature excursions. Provides routine reporting of drug wastage due to these excursions
• Archives Proof of Delivery (POD) documentation
• Maintains traceable documentation to support GXP activities
• Archives documentation on Trial Master Files as required

Qualifications

• Education and Experience: Degree in biological or life sciences, pharmacy or medicine (or international equivalent). A minimum of 3 years in the pharmaceutical industry or relevant work experience and a minimum of 1 year in Clinical Supply Chain.
• Familiarity with the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products
• Experience with Interactive Response Technology - IRT systems for inventory management and resupply
• Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities; working knowledge of GMP/GCP/GLP regulations

Skills

• Intermediate/Advanced knowledge of Microsoft Suites
• Solid written and verbal communication skills
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines
• Excellent interpersonal and communication skills
• Positive attitude with a strong desire for continuous learning