The Clinical Supply Manager leads the planning, creation and maintenance of supply project plans, based on study forecasts with Clinical and Medical project managers and contract providers.
Accountable for the scheduling and timely delivery of packaged clinical trial material, including randomization and the packaging, labeling of clinical supplies.
Implement packaging and labeling operations. Act as primary liaison between clinical personnel and contractor(s) on assigned projects.
Monitor clinical supply contractor set up, progress and implements corrective actions when issues arise.
Manages IVRS supply and drug return strategy with contractors and sites.
Manages Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed.
Interacts with Clinical sites, caregivers and patients regarding supply needs, storage and return of clinical supplies.
Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials.
Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
Participates as SME for clinical regulatory audits related to supply.
.5+ years’ experience in clinical supply management
Proficient with MS Office
Bachelors degree in science, nursing, engineering, pharmacy or related field