Global Study Lead Fsp Emea

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 general 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.
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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,

Strong experience leading global cross-functional teams within a matrix environment. Demonstrated ownership of study timelines, budgets, risks, quality and operational experience overseeing CROs and third-party vendors, including performance management and issue resolution. In-depth knowledge of ICH-GCP, global regulatory requirements and clinical development processes. Strong project and financial management capabilities. The ability to influence senior stakeholders and drive decisions in complex, fast-paced environments. Excellent leadership, communication, negotiation and conflict-management skills. Experience proactively identifying and resolving risks that could impact clinical programmes. Highly Desirable Experience in one or more of the following would be particularly valuable: Phase II and/or Phase III global clinical trials. Adaptive or other innovative trial designs. Decentralised clinical trials (DCTs). Platform, umbrella or basket studies. Technology-enabled clinical trial delivery, automation or AI/ML. Working with investigators, external experts and regulatory authorities. Broad therapeutic-area experience, combined with deep expertise in one or more indications. What Success Looks Like The successful Global Study Lead will be able to set the vision for study delivery, translate strategy into execution and bring diverse stakeholders together around clear priorities. xsgfvud
You will be comfortable making complex decisions autonomously, challenging constructively, escalating when required and empowering teams to deliver in demanding global clinical-development environments.

? Global Study Lead
- FSP EMEA (España)
? Thermo Fisher Scientific
? España