Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

Education Requirements

Experience Requirements

Key Skills

- 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.

📌 Global Study Lead - FSP - EMEA *Sign On Bonus* (Milano)
🏢 Thermo Fisher Scientific
📍 Milano