[alexion] Country Study Manager

Alexion

Fully remote
Gcp compliance
Regulatory requirements
Clinical trial delivery
Alexion is seeking a Country Study Manager responsible for overseeing clinical trials, ensuring compliance with Good Clinical Practice and regulatory requirements. The role involves collaboration with various stakeholders to achieve study milestones and manage site interactions

Job Summary

  • The Country Study Manager (CSM) is responsible for the local delivery of clinical studies in compliance with Good Clinical Practice (GCP) and regulatory requirements, working collaboratively to ensure timely and efficient study commitments.
  • Key responsibilities include ensuring site activation requirements are met, managing study contracts and budgets, overseeing monitoring activities, and driving quality efforts to identify and manage study-related risks.
  • The role requires proven experience in clinical trial operations, strong knowledge of ICH-GCP, effective 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 responsible for overseeing clinical trials, ensuring compliance with Good Clinical Practice and regulatory requirements. The role involves collaboration with various stakeholders to achieve study milestones and manage site interactions.

Skills & Requirements

Must-have

  • GCP compliance
  • Regulatory requirements
  • Clinical trial delivery
  • Site activation
  • Study documentation
  • Recruitment targets

Nice-to-have

  • Proactive risk management
  • Investigator training
  • Change management
  • Creative problem solving

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter