Senior Trial Supplies Manager
Core
Create and maintain supply strategies for all investigational products based on scientific and regulatory confines of drug development, ensuring timely delivery of quality clinical supplies for global studies.
Role type
Senior IC Trial Supplies Manager
Builds
Investigational product supply chains for global clinical studies
Domain
Pharmaceutical industry, Clinical Supply Chain
Required skills
Global drug development process knowledge, Regulatory requirements knowledge, Forecasting and planning, Project management, IVRS/CTMS systems knowledge, Import/export requirements knowledge, Manufacturing/Packaging/Labeling knowledge, Logistics knowledge, Quality/Stability knowledge, Conflict resolution, Negotiation, Mentoring
Preferred skills
Advanced analytical skills, Advanced communication skills, Advanced negotiation skills, Leadership, Coaching
Technologies
IVRS, CTMS, Budget Tool, eTMF, CSR appendices systems
Responsibilities
Define and communicate clinical supply chain strategy, Generate supply forecasts for complex studies, Issue Manufacturing and Packaging requests, Monitor use date of investigational drug product, Collaborate on IRT specifications, Procure commercial drug, Lead issue resolution, Prepare inspection readiness documentation, Enter product complaints and deviations, Write departmental procedural documents
Seniority
Senior, hands-on IC with mentoring responsibilities