Global Study Lead FSP EMEA Sign On Bonus

Work Schedule

Environmental Conditions

Job Description

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.
  

• Bachelors 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.