Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)

Overview

In this role, you will lead late-phase global trials within the Single Sponsor framework, ensuring timelines, budget adherence, and quality. You will collaborate across functions as part of the Clinical Trial Team to drive study success and lifecycle management. The position offers specialization in areas like SRC, NIS, MAP, IITs, RCs, or PLD, enabling impact across regulatory and operational domains. You’ll work with cross-functional partners to advance real-world evidence and patient outcomes while shaping trial documentation and processes. This is a strategic role for someone who thrives in a global, compliance-focused environment.

Responsibilities

• Draft protocol sections, case report forms, training materials, and data review plans
• Contribute to safety updates, packaging inserts (IBs), and regulatory submissions
• Oversee data review and TMF audit readiness
• Forecast and manage investigational product supply
• Support study closeout, issue resolution, and lifecycle budget tracking
• Coordinate Managed Access Program coordination and compliance
• Coordinate CRO/vendor selection and performance
• Facilitate advisory boards and serve as site liaison
• Lead cross-functional collaboration with data management and drug supply

Key requirements

• Advanced degree in life sciences or healthcare
• 2–5 years’ global experience managing phase IV, PASS, PAES, or NIS trials
• Strong track record in protocol development, study startup, and regulatory writing (PSURs, DSURs, NDA/BLA reports)
• Excellent communication, organizational, and collaboration skills
• Deep understanding of GCP and clinical trial design
• Passion for advancing real-world evidence and patient outcomes

• communication
• organization
• collaboration
• protocol development
• study startup
• regulatory writing (PSURs, DSURs, NDA/BLA)

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