Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated

📋 Description

• Prepare sections of protocols, case report forms (CRFs), training materials, and plans for data review.

• Assist in the creation of safety updates, investigator brochures (IBs), and submissions to regulatory bodies.

• Manage data review processes and ensure readiness for trial master file (TMF) audits.

• Predict and manage the supply of investigational products.

• Aid in study closeout activities, resolve issues, and track lifecycle budgets.

• Contribute to the coordination and compliance of the Managed Access Program.

• Oversee the selection and performance evaluation of contract research organizations (CROs) and vendors.

• Organize advisory boards, including Data Monitoring Committees (DMCs) and Steering Committees, and act as the liaison for sites.

• Drive collaboration across functions including data management and drug supply.

⛳️ Requirements

• Possession of an advanced degree in life sciences or healthcare.

• 2–5 years of global experience in managing phase IV, post-authorization safety studies (PASS), post-authorization efficacy studies (PAES), or non-interventional studies (NIS).

• Proven experience in protocol development, study initiation, and regulatory documentation (such as PSURs, DSURs, NDA/BLA reports).

• Exceptional communication, organizational, and teamwork abilities.

• Comprehensive knowledge of Good Clinical Practice (GCP) and clinical trial design principles.

🏝️ Benefits

• Health insurance.

• 401(k) plans.

• Paid time off.

• Flexible working arrangements.

• Opportunities for professional development.