Global Study Leader

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Description:

The Global Study Leader (GSL) leads global Phase I–IV clinical trials, overseeing strategy, execution and cross-functional alignment. They manage vendors, budgets, timelines, and documentation and serve as a Subject Matter Expert (SME) in audits, process design, and team leadership, ensuring Good Clinical Practice (GCP) compliance and operational excellence across studies.

Essential Functions/Responsibilities

• In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and ensure operational excellence.
• Delegate tasks to study team members as appropriate.
• Lead implementation, execution and management of global Phase I–IV clinical trials.
• Lead, facilitate and delegate trial-related meetings, ensuring alignment with cross-functional teams.
• Act as a primary point of escalation for cross-functional stakeholders for timely issue resolution and alignment.
• Participate in program-level discussions (FMT, GPT), providing clear and timely updates to senior management (as needed).
• Develop and execute clinical trial strategies in collaboration with cross-functional teams during the trial lifecycle including tracking and reporting trial progress, risks and mitigation strategies to senior leadership.
• Hold overall accountability for the Trial Master File (TMF). Acts as an SME for Clinical Operations related sections.
• Lead the development and review of trial—specific plans and essential clinical trial documents.
• Review and approve key trial documents including protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs) in line with Standard Operating Procedures (SOPs).
• Actively contributes to the operational oversight and strategic direction of assigned studies, including feasibility assessments, planning, vendor selection, patient recruitment strategies, and financial forecasting.
• Contribute to the planning and conduct of Investigator Meetings, including driving meeting preparation, presenting trial materials, and supporting effective delivery of key messages. ​
• Identify, assess, and proactively manage risk and contingencies to safeguard timelines, quality and compliance.
• Develop, manage and track trial timelines and budgets, in line with projected spend. Estimate, track and critically analyze vendor financial spend on trials.
• Accountable for the oversight and management of external service providers and vendors to ensure quality, compliance, and performance.
• Oversee trial tracking activities and ensure accurate, timely updates within trial management systems.
• Accountable for final approval and oversight of trial documentation archiving in compliance with regulatory and company requirements.
• Serves as trial lead and SME during audits and inspections.
• Coordinate Investigational Medicinal Product (IMP) shipment authorization with regulatory and clinical supplies functions.
• Assist and support data query process.
• Perform monitoring visit report review (as required).
• Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives (as assigned).
• Serves as a Clinical Operations SME in the design and review of processes.
• Ensure trial activities are conducted according to GCP and relevant SOPs and in accordance with the agreed timelines and trial protocol.
• Leadership / People Management Responsibilities:
  • Mentor and coach Global Study Managers (GSMs) Clinical Resea