Global Study Lead - FSP - EMEA

Work Schedule

Standard (Mon-Fri)

Office

The GSL is accountable for the end-to-end operational strategy, planning, and delivery of clinical studies from Commit to Study Initiation (CSI) through study archiving. The role owns the vision for study success, leads strategic decision-making, chairs cross-functional working groups, and represents Clinical Operations on the Study Leadership Team (SLT).

• Member of the Study Leadership Team (SLT) with accountability for study delivery to timeline, quality, budget, scientific requirements, and company standards.
• Provides strategic leadership and serves as the Clinical Operations escalation point.
• Oversees and supports the Global Study Manager (GSM) and Study Manager (SM) as needed.
• Ensures compliance with ICH/GCP, regulations, and GSK SOPs.
• Translates asset/program requirements into study execution plans and communicates with the Clinical Operations Asset Lead.
• Leads study risk management and mitigation activities.
• Owns stakeholder communication regarding study status, risks, and issues.
• Ensures robust feasibility, planning, governance, and financial review preparation.
• Accountable for study budget.
• Builds and leads empowered matrix teams.
• Champions innovative delivery models and technologies, including decentralized trials (DCTs) and AI/ML-enabled efficiencies.
• Provides strategic operational input into protocol development, informed consent forms, and key study documents.
• Oversees quality and inspection readiness.
• Leads process improvement initiatives.
• Serves as escalation point for vendor issues and oversees vendor selection and management.
• Bachelor's degree in Life Sciences or a related discipline.
• Strong understanding of complex clinical development and regulatory processes.
• Highly experienced strategic leader capable of independently leading multiple studies or a single large/complex study (at least 8+ years in global project management).
• Broad clinical delivery experience across indications, assets, phases, and regions.
• Extensive project management and clinical trial leadership experience.
• Proven success delivering studies to time, cost, and quality targets.
• Experience leading high-performing global study teams.
• Ability to influence stakeholders at Senior Director/VP level.
• Strong strategic thinking and ability to translate strategy into execution.
• Deep knowledge of study management, global regulations, and ICH/GCP.
• Experience managing CROs and third-party vendors.
• Strong budget management and negotiation skills.
• Expertise in innovative trial designs (adaptive, decentralized, platform, umbrella, basket trials).
• Excellent communication, conflict management, and decision-making skills.
• Ability to build relationships across complex matrix organizations.
• Growth mindset, psychological safety leadership, collaboration, and empowerment of others.

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.