Clinical Biomarker and Diagnostics Operations Lead

“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico 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                                      

• Biomarker Operations experience managing Biomarker samples, biomarker vendors and central labs.
• Project management experience and knowledge of project management tools, experience with software building timelines, experience organizing meetings, recording agenda and minutes.
• Extensive clinical development experience of working in teams running clinical studies, must be able to contribute to protocols and ICFs development.

Day to Day Responsibilities:                             
Specific Job Requirements:

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.

Essential Duties and Job Functions:

• Drives the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas
• Accountable for the development of a project’s and/or clinical study’s biomarker and diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness
• Accountable for project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies
• Accountable for planning and implementing the biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc
• Accountable for ensuring that data received is consistent with collection and assay plan and protocols
• Serves as first point of contact for biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinates with internal and external partners (e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)
• Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s)
• Provide regular reports on sample tracking to select samples for analysis based on varying criteria
• Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.
• Participate in site initiation visits to train sites on sample collection
• Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/ data results and is a key contact for the assay lab.
• Project manages contracts, budgets and timelines for biomarker/Dx activities within studies to ensure timely completion of biomarker and diagnostic activities.

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