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

IQVIA; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

IQVIA is seeking a Senior Global Trial Manager to lead late‑phase global studies within the Single Sponsor Department. You will own study deliverables, timelines, budgets, and quality, partnering across functions to drive successful outcomes.

Role demands an advanced life sciences degree and 2–5 years of global Phase IV/NIS trial experience, with strong skills in protocol development, regulatory writing, and cross‑functional collaboration.

Qualifications

• Experience managing late‑phase global trials (Phase IV, PASS, PAES, or NIS).
• Proven ability to lead protocol development, study startup, and regulatory writing.
• Strong communication, organizational, and collaboration skills.
• Deep understanding of GCP and clinical trial design.
• Interest in real‑world evidence and patient outcomes.

Responsibilities

• Draft and oversee sections of study documents, data reviews, and regulatory submissions.
• Lead project governance, timelines, budgets, and TMF audit readiness; manage drug supply forecasting.
• Coordinate CRO/vendor selection and cross‑functional collaboration with data management and regulatory teams.

Skills

Global trial management

Protocol development

Regulatory writing

Vendor & stakeholder management

Cross-functional collaboration

GCP knowledge

Education

Advanced degree in life sciences or healthcare

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.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

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