Senior Medical Data Reviewer

Amgen Inc

Doctorate or master's degree with experience
5-7+ years in biopharma clinical research
2+ years people management experience
The Senior Medical Data Reviewer is accountable for the end-to-end clinical data review quality and delivery across multiple Therapeutic Areas

Job Summary

  • The Senior Medical Data Reviewer is accountable for the end-to-end clinical data review quality and delivery across multiple Therapeutic Areas.
  • This role provides people leadership to Medical Data Reviewers and serves as the point of escalation for complex clinical data issues.
  • The position requires ensuring regulatory-ready documentation aligned with ICH-GCP while applying Risk-Based Quality Management (RBQM) principles.

Matching Summary

The Senior Medical Data Reviewer is accountable for the end-to-end clinical data review quality and delivery across multiple Therapeutic Areas.

Skills & Requirements

Must-have

  • Doctorate or Master's degree with experience
  • 5-7+ years in biopharma clinical research
  • 2+ years people management experience
  • Strong understanding of RBQM principles
  • Experience reviewing large complex clinical datasets

Nice-to-have

  • Proficiency in data analytics and visualization tools
  • Strong clinical reasoning and communication skills
  • Experience driving inspection readiness
  • Ability to leverage KRIs and QTLs

Key Requirements

  • Doctorate + 4 years OR Master's + 8 years
  • 5-7+ years in biopharma/CRO clinical research
  • 2+ years people management experience
  • Strong clinical reasoning skills
  • Proficiency in data analytics tools

Work Rights

Not specified

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