Global Study Lead

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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 p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gggbp