Clinical Supply Specialist – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Assists in the formulation and implementation of Clinical Supply strategies for all 4DMT’s Phase 1/2/3 investigational drug products and associated materials.

• Organizes and monitors bulk drug orders to ensure compliance with established supply and resupply schedules.

• Oversees daily site inventory; manages and tracks drug shipments to guarantee a continuous supply.

• Aids in the management and distribution of drug product inventory in collaboration with 4DMT’s clinical partners; assesses drug usage against forecasts while considering country-specific requirements and logistical timelines.

• Maintains accountability and reconciliation documentation at both study and depot levels to support regulatory compliance and facilitate study closure.

• Monitors and addresses temperature excursions at study and depot levels; provides regular reports on drug wastage resulting from these excursions.

• Archives Proof of Delivery (POD) documentation.

• Ensures traceable documentation is maintained to support GXP activities.

• Archives documentation on Trial Master Files as necessary.

⛳️ Requirements

• Bachelor’s degree in biological or life sciences, pharmacy, or medicine (or international equivalent).

• At least 3 years of experience in the pharmaceutical industry or relevant work experience.

• A minimum of 1 year of experience in Clinical Supply Chain.

• Proficient in the daily management and operations of a Clinical Supply Chain, including bulk management, distribution, and maintaining study blinding across multiple investigational products.

• Experienced in using Interactive Response Technology (IRT) systems for inventory management and resupply.

• Familiar with regulations pertaining to clinical labeling, packaging, and distribution; knowledgeable in GMP/GCP/GLP regulations.

🏝️ Benefits

• Equal employment opportunities for all employees and applicants regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, or any other category protected under applicable federal, state, provincial, and local laws.

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities