Assoc. Dir., Clinical Supply Project Manager - Protocol
Core
Design strategic and operational plans for clinical supplies across the full portfolio of clinical trials, serving as the primary interface between clinical development teams and operational execution arms.
Role type
Senior Associate Director, Clinical Supply Project Manager
Builds
End-to-end integrated clinical supply chain for company development products and non-company marketed products
Domain
Biopharmaceuticals / Clinical Trials / Supply Chain
Required skills
Project management, Supply chain planning, Risk analysis, Stakeholder negotiation, Protocol authoring, Change control management, Data analysis, GCP/GMP knowledge, SAP proficiency, Cross-functional leadership
Preferred skills
MS/MBA, ERP systems proficiency, Data analytics/visualization, Quality procedures knowledge
Technologies
SAP, IRT, Microsoft PowerApps, SWMS, Veeva, MEDS, Microsoft Excel, PowerPoint, Word, IVR Systems
Responsibilities
Establish timelines for clinical supply needs, negotiate timelines and strategy for clinical supplies on Clinical Trial Teams, analyze and prepare mitigation strategies for project risks, author clinical supply documentation and study protocol sections, process change controls and deviation records, support regulatory agency inspections, utilize key tools/systems for study management
Seniority
Senior, hands-on IC with strategic planning focus