Country Study Manager (alexion)

Alexion

Fully remote
Gcp compliance
Regulatory requirements
Site activation
Alexion is seeking a fully remote Country Study Manager to oversee clinical trials, ensuring compliance with GCP and regulatory requirements while collaborating with various stakeholders. The ideal candidate will have extensive experience in clinical trial operations and strong communication skills to manage relationships with site staff and regulatory bodies

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 at the country level.
  • Key responsibilities include quality and timeliness of study deliverables, proactive reporting of study-specific issues, meeting recruitment targets, CDA delivery and negotiation, ICF customization, and negotiation of site study contracts and budgets.
  • The role requires proven experience in clinical trial processes, strong knowledge of ICH-GCP, effective communication with site staff, and comprehensive regulatory knowledge.

Matching Summary

Match Score: 85

Alexion is seeking a fully remote Country Study Manager to oversee clinical trials, ensuring compliance with GCP and regulatory requirements while collaborating with various stakeholders. The ideal candidate will have extensive experience in clinical trial operations and strong communication skills to manage relationships with site staff and regulatory bodies.

Skills & Requirements

Must-have

  • GCP compliance
  • regulatory requirements
  • site activation
  • recruitment targets
  • study documentation
  • site monitoring

Nice-to-have

  • innovation-driven company
  • positive approach to change
  • creative thinker
  • curious and unafraid to ask questions

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