Global Study Lead – FSP Team

🔥 7 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – 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, planning, and end-to-end delivery of clinical studies from Commit to Study Initiation (CSI) through study archiving • Own the vision for study success, prioritize deliverables, and form working groups with matrix leadership, the Study Level Statistician, and Clinical Lead • Represent Clinical Operations on the Study Leadership Team (SLT) • Provide oversight and support to Global Study Managers (GSMs) and Study Managers (SMs) • Serve as the Clinical Operations escalation point • Ensure compliance with ICH/GCP, applicable laws and regulations, and GSK SOPs • Translate asset requirements into study requirements and communicate with the Clinical Operations Asset Lead • Assess risk/benefit and make study-impact decisions • Support working-group leads in identifying, overseeing, and mitigating study risks • Manage stakeholder communications regarding study status, expectations, risks, and issues • Ensure robust feasibility and upfront planning • Prepare materials for governance and financial review cycles • Own and manage the study budget • Build and lead empowered matrix teams • Implement innovative study-delivery approaches using technology and scientific advances • Decide on study-level innovative solutions, including decentralized clinical trials (DCTs) • Provide strategic operational input into protocols, informed consent forms, and other key study documents • Increase use of AI/ML tools and automate manual processes to improve efficiency • Oversee quality, protocol compliance, and continual inspection readiness • Lead or contribute to ways-of-working and process-improvement initiatives • Provide therapeutic-area expertise • Escalate and resolve vendor issues • Lead FSO-vendor assessment and selection with the Clinical Operations Asset Lead • Oversee FSO vendors and other study vendors with GSMs and SMs

🎯 Requirements

• Bachelor’s degree in life sciences or related discipline • Good understanding of complex clinical development and regulatory processes • Highly experienced strategic leader capable of performing a study accountable role autonomously across multiple studies or a single large/complex study • Extensive clinical development experience in pharmaceutical industry or CRO environment • Proven experience leading high-performing global clinical study teams • Ability to drive decision-making and strategically lead study teams autonomously in complex, high-pressure environments • Ability to influence and manage senior director and/or VP-level stakeholders • Ability to translate strategic concepts, stakeholder feedback, and requirements into cohesive study-team actions • Experience proactively identifying and resolving issues to ensure delivery to quality, timelines, and budget • Excellent leadership, influencing, negotiation, communication, conflict-management, project-management, and budget-management skills • Demonstrated matrix-environment leadership, change management, and project delivery experience • In-depth knowledge of study management, essential global regulatory guidelines, and ICH/GCP • Experience working with investigators, external experts, regulatory agencies, CROs, and third-party vendors • Ability to establish internal and external relationships in dynamic, matrixed environments • Strategic leadership experience with innovative trial designs, including adaptive designs and decentralised trials (DCT), with learning agility for platform, umbrella, and basket designs • Very strong therapeutic-area experience • Growth mindset and mental agility across therapeutic areas and study types • Ability to create psychological safety, foster collaboration, empower others, and connect people with organizational purpose

🏖️ Benefits

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

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