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Clinical Biomarker and Diagnostics Operations Lead

South San Francisco, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puertorico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
                                                            
Top 3 Must Have Skills
  • Experience with planning and implementing the biomarker and diagnostics biosamples collection plans within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up.
  • Project management experience in the implementation of clinical trial assays at reference labs and centralized testing vendors, ensuring delivery of assay/ data results and being a key contact for the assay lab; project management skills and knowledge of project management tools is required.
  • Experience working with major CROs, providing vendor oversight.

Day to Day Responsibilities
  • The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the Amgen biomarker and diagnostics strategies for programs in the Inflammation and Cardio Metabolic therapeutic areas of Amgen (General Medicine). He/she ensures continuity and integrity across projects, coordinates assay development and implementation activities and acts as the primary point of contact for CBD operations for projects requiring biomarker and diagnostic activities including collection, delivery and analysis of biomarker and diagnostics biosamples within one or more clinical projects or clinical studies. He/she is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

"This posting is for Contingent Worker, not an FTE"

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