Strategy Lead

Job Summary

A company is looking for a Strategy Lead to provide leadership and guidance in clinical research operations.

Key Responsibilities

• Provide guidance on operating model processes and documentation for study teams, ensuring inspection readiness
• Manage inspection readiness planning and oversee the development of key deliverables for audits and inspections
• Oversee TMF performance and compliance, ensuring adherence to TMF plans and risk-based oversight strategies

Required Qualifications

• Minimum of 6+ years of clinical research experience in the pharmaceutical or biotechnology field
• Solid knowledge of GCP compliance and regulatory inspection readiness
• Experience with CROs and clinical trial activities, with sponsor experience preferred
• Knowledge of drug development and clinical trial processes
• Experience in clinical trials systems management, preferably with Veeva