“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

• In-depth knowledge/experience of data collection, analysis, and reporting in drug development and clinical trials processes **IS A MUST**
• Collaborating in global cross-functional teams
• Experience in project management, documentation writing, training, and compliance
• Interest in process improvement methodologies
• Use of software and data applications within drug development
• Appreciation of computer system architecture and hardware
• Experience with metadata repositories not necessary, but must have a willingness to learn the metadata repository application and underlying data tables and be comfortable extracting data from databases for reporting.

Day to Day Responsibilities

• Designing, defining, and reviewing data quality edit checks for inclusion in data standards and in consultation with study teams for study-level implementation
• Developing and maintaining processes for the design and implementation of data quality edit checks
• Manage data standards collection components (forms, fields, controlled terminology (i.e., codelists), edit checks, derivations) in a metadata repository (MDR)
• Participate in the definition and maintenance of data standards collection components
• Review/audit study-level deliverables for compliance to data standards
• Develop and compile metrics for communicating outcomes of data standard compliance reviews/audits
• Provide additional support to study teams on the adoption of data standards
• Drive and facilitate the expansion of data standards across Amgen Global Development

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