As the Clinical Supply Associate, you will manage many aspects of the supply chain for assigned projects in support of the planning, execution, and close out of Phase I - IV clinical studies to ensure the objectives of the studies are met.
- Provide oversight of domestic and international shipments of Drug Substance, Drug Product and Clinical Supplies.
- Ensure adequate stock at vendor depots, sites and IMVT US Depot.
- Generate and/or review shipment requests for accuracy completeness prior to issuance.
- Keep internal customers informed of that status of their shipment(s).
- Place and coordinate shipments requests from contact manufactures to US Depot.
- Ensure accuracy of IP receipt for all shipments and availability in IRT for applicable studies.
- Ensure all critical parameters are considered for every distribution strategy; IRT specifications (e.g., initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage, or country specific requirements.
- Support relabeling activity or transfers between sites
- Serve as point of contact for Returned Products
- Ensure final drug reconciliation is completed and accurate at site, depot and study level.
- Provide adequate communication and documentation relevant to the clinical study plan and the movement of all investigational products.
- Ensure that goals and objectives of projects are accomplished within established time frames and budget guidelines.
- Prepare a variety of narrative and analytical reports, documents, and correspondence for contracting agencies, team members, participating departments and senior management regarding trial status
- Other tasks as assigned by management
This is a great opportunity to join a recession-proof company/industry. There is tremendous amounts of stability in the Pharma industry, especially in NJ. It's the top industry in the state.
- Bachelor's degree from an accredited college or university.
- 3 years of health sciences experience is required; pharmaceutical industry or related experience is preferred; work in the areas of supply chain, and/or project management a plus.
- Demonstrated knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly.
- Must be able to work autonomously with minimal supervision
- Proven thorough understanding of GMP, GDP (IP production and distribution) as well as a thorough understanding of IRT systems.