Global Study Lead – FSP EMEA

🔥 11 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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 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 external vendors, including vendor selection, performance management and escalation • Ensure compliance 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 to senior stakeholders and governance forums • Champion decentralised trial approaches, technology, automation and AI-enabled ways of working • Contribute to Clinical Operations continuous improvement initiatives

🎯 Requirements

• 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 • 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 • Experience in Phase II and/or Phase III global clinical trials, adaptive or innovative trial designs, decentralised clinical trials, platform/umbrella/basket studies, technology-enabled delivery, automation or AI/ML, and working with investigators, external experts and regulatory authorities is highly desirable

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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