Global Study Lead

21 set - Roma
Thermofisher Scientific

Work Schedule

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Standard (Mon-Fri)

Environmental Conditions

Office

Job Description
The Opportunity
We are seeking an experienced Global Study Lead (GSL) to provide strategic and operational leadership for complex global clinical studies.

This is a senior study leadership position with end-to-end accountability for clinical study delivery, from study initiation through to study close-out and archiving. You will define the operational strategy, lead cross-functional study teams, and ensure studies are delivered to the required timelines, quality, budget and regulatory standards.

As a key member of the Study Leadership Team, you will represent Clinical Operations and work closely with Clinical, Statistics and other cross-functional partners to drive decisions, manage risk and ensure successful study delivery.

Key Responsibilities

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- Lead the operational strategy and end-to-end delivery of one or more global clinical studies.
- Own study timelines, budget, quality, risks and key operational deliverables.
- Provide strategic leadership to global, cross-functional study teams and drive timely decision-making.
- Represent Clinical Operations within the Study Leadership Team and act as the senior escalation point for operational issues.
- Translate clinical development and asset strategy into clear study-level operational plans.
- Lead proactive study risk identification, mitigation and issue resolution.
- Ensure robust feasibility, study planning and operational execution.
- Provide strategic operational input into protocols, informed consent forms and other key study documents.
- Oversee CROs and other external vendors, including vendor selection, performance management and escalation where deliverables are at risk.
- Ensure studies remain compliant with ICH-GCP, applicable regulations, SOPs and inspection-

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