Country Study Manager (alexion)

AstraZeneca

Warsaw, Poland
Fully remote
Gcp and regulatory compliance
Site activation requirements
Study deliverables quality and timeliness
The Country Study Manager is responsible for the local delivery of studies in compliance with Good Clinical Practice (GCP) and regulatory requirements, ensuring timely and efficient study commitments

Job Summary

  • The Country Study Manager is responsible for the local delivery of studies in compliance with Good Clinical Practice (GCP) and regulatory requirements, ensuring timely and efficient study commitments.
  • Key responsibilities include managing site activation, recruitment targets, data deliverables, contract negotiations, and regulatory documentation for assigned studies.
  • The role requires proven experience in clinical trial operations, strong knowledge of ICH-GCP, and the ability to lead, troubleshoot, and influence for quality and delivery.

Matching Summary

The Country Study Manager is responsible for the local delivery of studies in compliance with Good Clinical Practice (GCP) and regulatory requirements, ensuring timely and efficient study commitments.

Skills & Requirements

Must-have

  • GCP and regulatory compliance
  • Site activation requirements
  • Study deliverables quality and timeliness
  • Recruitment targets achievement
  • Clinical trial process oversight
  • ICH-GCP guidelines knowledge

Nice-to-have

  • Change management positive approach
  • Creative and curious mindset
  • Flexibility in schedule and travel
  • Team oriented and flexible

Key Requirements

  • 3+ years of relevant experience
  • Lead CRA/Senior CRA experience
  • Bachelor's Degree or equivalent
  • Valid driving license

Work Rights

Not specified

Tailored Resume

Cover Letter