Note: The job is a remote job and is open to candidates in USA. AllSTEM Connections is seeking a Clinical Supply Chain Manager to work remotely. The role involves managing electronic Trial Master Files for clinical supplies across multiple client studies, ensuring document readiness for inspection and overseeing supply planning within clinical studies.
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
- Clinical Study Planning - 2027
- Overseeing or executing tasks across demand forecasting, supply planning and inventory management of product within a clinical study
Skills
- Doctorate degree or Master degree and 3 years of experience or Bachelor degree and 5 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience and previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
- 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
- 5-10 YOE post-graduation managing clinical supplies through CROs and CMOs
- Clinical supply chain experience with CMOs and CROs
- Proficiency with Veeva Vault eTMF
Company Overview