Global Study Manager Global Study Lead FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

• 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.