[alexion] Country Study Manager

Alexion

**
Gcp compliance
Regulatory requirements
Site activation
** Alexion is seeking a Country Study Manager (CSM) responsible for overseeing clinical studies at the country level, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. The role involves collaboration with various teams, managing site activations, and engaging with regulatory authorities to support study commitments in a timely and efficient manner. **

Job Summary

  • The Country Study Manager is responsible for the local delivery of clinical studies in compliance with GCP and regulatory requirements, working closely with various teams to ensure timely and efficient study execution.
  • Key responsibilities include ensuring site activation, managing study deliverables, meeting recruitment targets, negotiating contracts and budgets, and overseeing monitoring activities.
  • The role requires strong communication, organizational, and problem-solving skills, with a preference for candidates who can manage change positively and work effectively in a remote and matrix environment.

Matching Summary

Match Score: 75

** Alexion is seeking a Country Study Manager (CSM) responsible for overseeing clinical studies at the country level, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. The role involves collaboration with various teams, managing site activations, and engaging with regulatory authorities to support study commitments in a timely and efficient manner. **

Skills & Requirements

Must-have

  • GCP compliance
  • Regulatory requirements
  • Site activation
  • Study deliverables quality
  • Recruitment targets
  • Clinical monitoring documentation review

Nice-to-have

  • Remote collaborators
  • Matrix reporting structure
  • Positive change management
  • Creative problem solving
  • Risk Based Quality Management principles

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter