Sr Amendment Implementation Specialist

3 days ago


Remote, Oregon, United States Thermo Fisher Scientific Full time

Job Summary

The Sr Amendment Implementation Specialist will be responsible for completing amendment activities within assigned projects and ensuring amendment deliverables meet customer expectations and contracted milestones. This includes providing accurate projections, report updates, and ongoing risk assessments.

Key Responsibilities

  • Understand amendment scope, classification, timelines, and whether participant safety is affected
  • Collaborate with the project team on amendment planning
  • Discuss financial coverage for the amendment with the Project Lead
  • Schedule and conduct progress check calls with local teams
  • Update Principal Investigator Amendment Notification and Implementation Letters
  • Liaise with the Regulatory Affairs Lead and project team to assess amendment submission requirements and country submission timelines
  • Update forecasting and actuals for amendment-related units according to Clarity monthly deadlines
  • Inform project team members when amendment activities have been completed
  • Perform risk identification and contingency planning pertaining to amendments
  • Introduction of roles and responsibilities to local team

Requirements

  • Audit/inspection process awareness with relevant rules and guidance documents
  • Expert knowledge of an application (e.g. Excel), system or process
  • Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
  • Analytical skills, ability to comprehend and analyze data, tables, etc.
  • Flexibility to reprioritize workload to meet changing project timelines
  • Advanced English (verbal & written)
  • Good computer skills, proficient in several MS Office (Word, Excel, Power Point) and ability to obtain knowledge and master all clinical trial database systems
  • Strong collaborators, very good interpersonal skills, capable to shift prioritization according to project needs and timelines

About Thermo Fisher Scientific

Thermo Fisher Scientific is an innovative, forward-thinking organization that offers employment with outstanding career and development prospects. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

Equal Employment Opportunity

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.



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