Supports the development and execution of Clinical Supply strategies for all 4DMT’s Phase 1/2/3 investigational drug products and ancillaries.
Coordinate and track bulk drug orders to ensure adherence to pre-defined supply and resupply timelines.
Monitor site inventory on a daily basis; coordinate and track 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. Provide routine reporting of drug wastage due to these excursions.
Archives Proof of Delivery (POD) documentation.
Maintain traceable documentation to support GXP activities.
Archives documentation on Trial Master Files as required.

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.
A minimum of 1 year in Clinical Supply Chain.
Familiar in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products.
Experienced 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.

Equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Clinical Supply Specialist – Contract

Key skills