Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based i
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Job Description
Senior Global Trial Manager – Single Sponsor Are you experienced in managing late phase clinical trials at a global level? We are looking for a Senior Global Trial Manager to join our Single Sponsor Department .
Join our global team and take ownership of delivering late-phase clinical trials that meet timelines, budgets, and quality standards. As a core Clinical Trial Team (CTT) member, you'll lead critical aspects of global studies and collaborate across functions to drive success.
As part of your role, you’ll have the opportunity to specialise in one for the following areas: ·Scientific Review Committee (SRC) ·Non-Interventional Studies (NIS) ·Managed Access Programs (MAP) ·Investigator-Initiated Trials (IITs) ·Research Collaborations (RCs) ·Program Level Documents (PLD)
Key Responsibilities
Clinical Documentation & Study Tools Draft sections of protocols, CRFs, training materials, and data review plans Contribute to the development of safety updates, IBs, and regulatory submissions Project Leadership Oversee data review and TMF audit readiness Forecast/manage investigational product supply Support study closeout, issue resolution, and lifecycle budget tracking Contribute to Managed Access Program coordination and compliance Vendor & Stakeholder Management Coordinate CRO/vendor selection and performance Facilitate advisory boards (DMCs/Steering Committees) and serve as the site liaison Lead cross-functional collaboration with data management, drug supply, and more What You'll Bring 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 (e.
g. 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 Please note this role is not eligible for the UK visa sponsorship.
Required Skills
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