Clinical Safety Professional

4 days ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time
CK Group is seeking an experienced Clinical Safety professional to lead clinical safety activities for a clinical-stage biotech. As an Associate Director level role, you will be responsible for managing safety within the clinical study teams and providing input to the design and preparation of protocols.

Key Responsibilities:
  • Manage safety evaluation activities including First in Human (FIH) studies.
  • Carry out regular reviews of emerging safety data and present important safety issues to senior management and other stakeholders.
  • Author safety assessments and reports for signals or regulatory authority requests.

Salary: Circa £100 per hour, based on industry standards and location requirements.

Requirements:
  • Significant experience in clinical safety.
  • Excellent knowledge of regulations (FDA, EU, ICH).
  • Previous experience in managing multiple programmes.

This is a 6-month contract with the opportunity to work remotely 4 days a week and on-site 1 day a week.

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