Global Study Lead - End-to-End Clinical Delivery (EMEA)

ThermoFisher Scientific; Roma; Ibrido; EUR 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific in Rome, Italy, is seeking an experienced Global Study Lead 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

Competenze

• Experience leading global clinical studies in pharma/biotech.
• Experience end-to-end accountability for complex trials.
• Strong leadership of cross-functional teams in matrix environment.
• Proven ownership of timelines, budgets, risks, quality and operational strategy.
• Experience overseeing CROs and vendors, with performance management.
• Knowledge of ICH-GCP and global regulatory requirements.

Mansioni

• 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 and governance forums.
• Champion innovative approaches to clinical trial delivery, including decentralised trial approaches, technology, automation and AI-enabled ways of working.
• Contribute to continuous improvement initiatives across Clinical Operations.

Conoscenze

Global study leadership

Cross-functional leadership

ICH-GCP knowledge

Budget and forecasting

Vendor management

Regulatory awareness

Strategic decision-making

Communication & negotiation

Risk management

Formazione

Bachelor's degree in Life Sciences or related

Descrizione del lavoro

Thermo Fisher Scientific in Rome, Italy, is seeking an experienced Global Study Lead 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