Clinical Risk Lead

Alimentiv

Austin, United States
On-site
Ich gcp e6 requirements
Risk assessments and management
Clinical monitoring strategy
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
  • risk assessments and management
  • clinical monitoring strategy
  • RBQM principles application

Nice-to-have

  • guidance and consistency
  • training delivery

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter