Global Study Lead - FSP 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

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 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.

About You

You will be an accomplished clinical operations professional with significant experience leading complex global clinical studies within the pharmaceutical or biotechnology industry.

You will bring:

• A Bachelor's degree in Life Sciences or a related discipline.

• Extensive experience in global clinical study delivery, ideally across multiple phases, indications and geographic regions.

• Proven experience holding end-to-end accountability for complex global clinical trials.

• Strong experience leading global cross-functional teams within a matrix environment.

• Demonstrated ownership of study timelines, budgets, risks, quality and operational strategy.

• Significant 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. You will be comfortable making complex decisions autonomously, challenging constructively, escalating when required and empowering teams to deliver in demanding global clinical-development environments.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.