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Data Standard Consultant

Raleigh, NC
“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"

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