Country Study Manager (alexion)

Alexion

Fully remote
Gcp and regulatory compliance
Site activation requirements
Study deliverables quality
Alexion is seeking a Country Study Manager (CSM) to oversee clinical study operations in compliance with Good Clinical Practice (GCP) and regulatory standards. The role involves collaboration with various stakeholders to ensure timely delivery and quality of study outcomes within the rare disease sector

Job Summary

  • The Country Study Manager is responsible for the local delivery of studies in compliance with GCP and regulatory requirements, working closely with various teams to ensure timely and efficient study commitments.
  • Key responsibilities include ensuring site activation, managing recruitment targets, overseeing monitoring activities, negotiating contracts and budgets, and coordinating regulatory submissions.
  • The role requires proven experience in clinical trial operations, strong knowledge of ICH-GCP, excellent communication skills, and the ability to lead, troubleshoot, and influence for quality and delivery.

Matching Summary

Match Score: 85

Alexion is seeking a Country Study Manager (CSM) to oversee clinical study operations in compliance with Good Clinical Practice (GCP) and regulatory standards. The role involves collaboration with various stakeholders to ensure timely delivery and quality of study outcomes within the rare disease sector.

Skills & Requirements

Must-have

  • GCP and regulatory compliance
  • Site activation requirements
  • Study deliverables quality
  • Recruitment targets
  • Site monitoring activities
  • Risk management

Nice-to-have

  • Change management
  • Creative problem solving
  • Innovation
  • Team oriented
  • Flexibility

Key Requirements

  • 3+ years of relevant experience
  • Bachelor's Degree or equivalent
  • Proven experience in clinical trial oversight
  • Solid knowledge of clinical development processes
  • Excellent knowledge of ICH-GCP
  • Comprehensive regulatory knowledge

Work Rights

Not specified

Tailored Resume

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