Global Trial Manager, Late Phase Studies

This is a fully remote position, open to applicants in Spain.

📋 Description

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

• Assist in the creation of safety updates, Investigator's Brochures (IBs), and regulatory submissions

• Manage data review processes and ensure readiness for Trial Master File (TMF) audits

• Anticipate and manage the supply of investigational products

• Aid in study closure, resolution of issues, and tracking of lifecycle budgets

• Coordinate the selection and performance evaluation of CROs and vendors

• Organize advisory boards (Data Monitoring Committees/Steering Committees) and act as the liaison for sites

⛳️ Requirements

• Master’s or doctoral degree in life sciences or healthcare

• 2–5 years of international experience in managing phase IV, PASS, PAES, or NIS trials

• Proven expertise in protocol creation, study initiation, and regulatory documentation (e.g., PSURs, DSURs, NDA/BLA reports)

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

• Exceptional communication, organizational, and teamwork abilities

🏝️ Benefits

• Flexible working arrangements

• Opportunities for professional development