Clinical Trial, Communication Skills, Contract Manufacturing, Contract Research Organization (CRO), Cross-Functional, Documentation, GxP, Health Plan, Interpersonal Skills, Inventory Management, Logistics, Management of Information Systems/Technology (MIS), Medical Products, Reconciliation, Supply Chain, Supply Chain Management
Our Client, a Biopharmaceutical company, is looking for a Clinical Supply Chain Manager for their Remote location.
Responsibilities:
- Inspection Readiness for clinical programs and studies - 2026
- Review clinical supply eTMF's to determine missing or mis-filed documents
- Retrieve documents from various internal repositories and systems
- Retrieve documents from external vendors, i.e. logistic service providers, distribution-storage/pass-through depots, CROs, etc.
- Support document upload in eTMF and ensure document readiness for inspection
- Organize documents in Inspection Readiness trackers per program and clinical study
- Ensure all documents are logged in a consistent and traceable manner
- Support inventory reconciliation for inspection readiness
Requirements:
- 5+ years and deep understanding of clinical supply chain packaging, labeling, distribution, storage from set up and launch of clinical trial supplies to study closure and clinical trial supply reconciliation/accountability and depot shut down within a regulated biopharmaceutical environment (experience with GXP guidelines)
- 5+ years of experience with packaging/labeling vendors, their processes and documentation
- 5+ years' experience with contract research organizations (CRO), contract manufacturing organizations (CMO), logistics service providers (LSP), etc.
- Proficiency with Smartsheet, Veeva Vault, and Excel
- Excellent communication and interpersonal skills to interface effectively across multiple functions.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities