[alexion] Country Study Manager

Alexion

Fully remote
Gcp and regulatory requirements
Site activation requirements
Study deliverables quality and timeliness
Alexion is seeking a Country Study Manager to oversee clinical trial operations, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. The role involves collaboration with various stakeholders to manage study timelines, site activations, and regulatory submissions, all while maintaining a focus on quality and recruitment goals

Job Summary

  • The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements.
  • You will be responsible for Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).
  • Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.

Matching Summary

Match Score: 85

Alexion is seeking a Country Study Manager to oversee clinical trial operations, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. The role involves collaboration with various stakeholders to manage study timelines, site activations, and regulatory submissions, all while maintaining a focus on quality and recruitment goals.

Skills & Requirements

Must-have

  • GCP and regulatory requirements
  • site activation requirements
  • study deliverables quality and timeliness
  • recruitment targets
  • site monitoring activities
  • risk management

Nice-to-have

  • remote collaborators
  • matrix reporting structure
  • positive approach to change
  • creative problem solving
  • innovator

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter