Clinical Risk Lead

Alimentiv

Manchester, United Kingdom
On-site
Ich gcp e6 requirements
Project risk assessments
Risk management plans
Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements

Job Summary

  • Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements.
  • The Clinical Risk Lead will coordinate the development of project specific risk assessments, risk management plans and Integrated Strategic Monitoring Plans (ISMPs) during study start up whilst driving compliance to these plans throughout the project lifecycle.
  • The Clinical Risk Lead will maintain the risk library and provide guidance to ensure consistency within the organization in terms of risk assessment and management.

Matching Summary

Responsible for the oversight of risk management activities on a portfolio of clinical projects in accordance with ICH GCP E6 requirements.

Skills & Requirements

Must-have

  • ICH GCP E6 requirements
  • project risk assessments
  • risk management plans
  • Integrated Strategic Monitoring Plans
  • risk library maintenance
  • RBQM principles application

Nice-to-have

  • guidance and consistency
  • training delivery
  • collaboration with functional leads

Key Requirements

  • ICH GCP E6 compliance
  • Risk assessment and management experience
  • Clinical monitoring strategy development

Work Rights

Not specified

Tailored Resume

Cover Letter