21 set - Italia
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Work Schedule
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
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-readiness requirements.
Lead study financial planning, forecasting and budget management.
Communicate study progress, risks, decisions and recommendations effectively to senior stakeholders a
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