Develop strategic long term supply strategies supporting a pull based replenishment model in a clinical regulated environment. Work with suppliers on managing Lot Phase-In, Material Sequestering and release scheduling.
Plan, organize and oversee the collection and shipping of biosamples from investigator sites or centralized locations and subsequent delivery to assay laboratories. Partner with the SET to ensure the delivery of biosample data in accordance with study timelines.
Collaborate with cross functional Study Execution Team (SET) members and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements.
Lead the S&OP management reviews, prepare all data and metrics for review, identify gaps and scenarios that must be presented, guide final decision making on open items and trade-offs, and prepare escalations for executive review where appropriate.
Shaping and leading the business solution implementation: defining and supervising business architecture, process design and development activities, developing capabilities and performance measurements/KPI's.
Oversees implementation of clinical trials within a program outlined in the Clinical Development Plan (CDP) by managing and communicating timelines, budget (i.e. accurate assumptions and cost projections), resources, priorities, and clinical activities inclusive of proactively identifying and mitigating study/program risks.
Execute high-quality, integrated, cross-functional plans for assigned clinical trials by coordinating day-to-day activities with functional groups in the clinical study team both internal and external to company.
The Clinical Operations Project Manager (CPM) is responsible for managing Clinical Operations vendor selection and contracting activities, managing Clinical Trial Associates, and facilitating the US Clinical Operation department to efficiently manage tasks and share information.
Manage cross-functional Study Execution Team(s) (SET) and vendor efforts to ensure Five Prime clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
Must possess strong data analysis skills and will be responsible for industry assessments, financial analysis, support for vendor selection, contract/budget negotiations, and contribute to cost modeling.