ppbWork Schedule /b /p pStandard (Mon-Fri) /p pbEnvironmental Conditions /b /p pOffice /p h3Job Description /h3 h3The Opportunity /h3 pWe are seeking an experienced Global Study Lead (GSL) to provide strategic and operational leadership for complex global clinical studies. /p pThis 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. /p pAs 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. /p h3Key Responsibilities /h3 ul lipLead the operational strategy and end-to-end delivery of one or more global clinical studies. /p /li lipOwn study timelines, budget, quality, risks and key operational deliverables. /p /li lipProvide strategic leadership to global, cross-functional study teams and drive timely decision-making. /p /li lipRepresent Clinical Operations within the Study Leadership Team and act as the senior escalation point for operational issues. /p /li lipTranslate clinical development and asset strategy into clear study-level operational plans. /p /li lipLead proactive study risk identification, mitigation and issue resolution. /p /li lipEnsure robust feasibility, study planning and operational execution. /p /li lipProvide strategic operational input into protocols, informed consent forms and other key study documents. /p /li lipOversee CROs and other external vendors, including vendor selection, performance management and escalation where deliverables are at risk.



/p /li lipEnsure studies remain compliant with ICH-GCP, applicable regulations, SOPs and inspection-readiness requirements. /p /li lipLead study financial planning, forecasting and budget management. /p /li lipCommunicate study progress, risks, decisions and recommendations effectively to senior stakeholders and governance forums. /p /li lipChampion innovative approaches to clinical trial delivery, including decentralised trial approaches, technology, automation and AI-enabled ways of working. /p /li lipContribute to continuous improvement initiatives across Clinical Operations. /p /li /ul h3About You /h3 pYou will be an accomplished clinical operations professional with significant experience leading complex global clinical studies within the pharmaceutical or biotechnology industry. /p pYou will bring: /p ul lipA Bachelor's degree in Life Sciences or a related discipline. /p /li lipExtensive experience in global clinical study delivery, ideally across multiple phases, indications and geographic regions. /p /li lipProven experience holding end-to-end accountability for complex global clinical trials. /p /li lipStrong experience leading global cross-functional teams within a matrix environment. /p /li lipDemonstrated ownership of study timelines, budgets, risks, quality and operational strategy. /p /li lipSignificant experience overseeing CROs and third-party vendors, including performance management and issue resolution.



/p /li lipIn-depth knowledge of ICH-GCP, global regulatory requirements and clinical development processes. /p /li lipStrong project and financial management capabilities. /p /li lipThe ability to influence senior stakeholders and drive decisions in complex, fast-paced environments. /p /li lipExcellent leadership, communication, negotiation and conflict-management skills. /p /li lipExperience proactively identifying and resolving risks that could impact clinical programmes. /p /li /ul h3Highly Desirable /h3 pExperience in one or more of the following would be particularly valuable: /p ul lipPhase II and/or Phase III global clinical trials. /p /li lipAdaptive or other innovative trial designs. /p /li lipDecentralised clinical trials (DCTs). /p /li lipPlatform, umbrella or basket studies. /p /li lipTechnology-enabled clinical trial delivery, automation or AI/ML. /p /li lipWorking with investigators, external experts and regulatory authorities. /p /li lipBroad therapeutic-area experience, combined with deep expertise in one or more indications. /p /li /ul h3What Success Looks Like /h3 pThe 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. /p pThermo 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. /p /p #J-18808-Ljbffr

📌 Global Study Lead - FSP EMEA (Roma)
🏢 Thermofisher Scientific
📍 Roma