[alexion] Country Study Manager

Alexion

**
Gcp compliance
Regulatory requirements
Site activation
** Alexion is seeking a Country Study Manager to oversee the delivery of clinical studies, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. The role involves collaboration with various stakeholders to meet study commitments and manage site activation and monitoring activities. **

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: 75

** Alexion is seeking a Country Study Manager to oversee the delivery of clinical studies, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. The role involves collaboration with various stakeholders to meet study commitments and manage site activation and monitoring activities. **

Skills & Requirements

Must-have

  • GCP compliance
  • regulatory requirements
  • site activation
  • recruitment targets
  • study documentation
  • negotiation of contracts and budgets

Nice-to-have

  • flexible schedule
  • creative problem solver
  • positive approach to change
  • team oriented
  • curious and unafraid to ask questions

Key Requirements

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

Work Rights

Not specified

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