South San Francisco, CA30+ days ago
Manages relationships with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations Works closely with QA to ensure compliance around SOPs. Manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, Blinding strategies and maintaining the blind, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.