Thermo Fisher Scientific
Global Study Lead - FSP - EMEA *Sign On Bonus*
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Global Study Lead – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.**
Role Purpose:
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).
Key Responsibilities
- 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.
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Education Requirements
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Experience Requirements
Key Skills
- 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.
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