​​Global Study Leader​

About the role

In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and operational excellence. Leads implementation, execution and management of global Phase I–IV clinical trials and serves as the primary escalation point for cross-functional stakeholders. Holds accountability for the Trial Master File (TMF) and acts as a subject-matter expert for Clinical Operations–related sections. Drives the development and review of trial-specific plans and essential documents, and provides clear, timely updates to senior management. Contributes to program-level discussions and oversees risk management, timelines, budgets, vendor performance, and regulatory compliance throughout the trial lifecycle.

Responsibilities

• Provide oversight for global Phase I–IV clinical trials in collaboration with cross-functional teams and external service providers.
• Delegate tasks and lead trial-related meetings to ensure alignment across stakeholders.
• Serve as primary escalation point for timely issue resolution and alignment.
• Participate in program-level discussions (e.g., FMT, GPT), providing updates to senior leadership as needed.
• Develop and execute clinical trial strategies, including tracking progress, risks, and mitigation strategies.
• Hold overall accountability for the Trial Master File (TMF) and ensure compliance with regulatory and company requirements.
• Lead the development and review of trial-specific plans and essential documents such as protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs).
• Review and approve key trial documents in accordance with Standard Operating Procedures (SOPs).
• Contribute to operational oversight and strategic direction of assigned studies, including feasibility assessments, planning, vendor selection, patient recruitment strategies, and financial forecasting.
• Plan and conduct Investigator Meetings, including preparation, presentation, and delivery of key messages.
• Identify, assess, and proactively manage risks and contingencies to safeguard timelines, quality, and compliance.
• Develop, manage, and track trial timelines and budgets, including estimating, tracking, and analyzing vendor financial spend.
• Oversee external service providers and vendors to ensure quality, compliance, and performance.
• Ensure accurate, timely updates within trial management systems and final approval and oversight of trial documentation archiving.
• Serve as trial lead and subject-matter expert during audits and inspections.
• Coordinate Investigational Medicinal Product (IMP) shipment authorization with regulatory and clinical supplies functions.
• Support data query processes and monitoring visit report reviews as required.
• Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives as assigned.
• Provide Clinical Operations expertise in the design and review of processes.
• Ensure trial activities are conducted according to GCP, relevant SOPs, and the agreed timelines and trial protocol.

Leadership / People Management Responsibilities

• Mentor and coach Global Study Managers (GSMs), Clinical Research Associates (CRAs), and Global Study Associates (GSAs) to support professional development.
• Lead Clinical Trial Working Groups (CTWGs).
• Provide leadership in resolving complex trial issues and escalating risks appropriately.
• Manage and maintain high-performing clinical teams.

Required Knowledge, Skills, and Abilities

• 7+ years of clinical research experience, including proven global trial management and portfolio-level oversight.
• Minimum of 3 years in clinical operations leadership roles.
• Excellent organizational skills, time management, and attention to detail.
• Excellent written and verbal communication skills and strong stakeholder management abilities.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with and strong knowledge of clinical trial electronic systems (e.g., TMF, CTMS).
• Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
• Strong knowledge of regulatory start-up processes and planning in support of Study Start-Up (SSU).
• Proven track record of effectively managing in a cross-functional environment.
• Excellent project management skills with a proven track record of managing global, multi-center clinical trials.
• Strong leadership and governance experience; ability to influence at senior levels.

Requirements

• Bachelor’s degree, preferably in life sciences, healthcare, or a related field, or equivalent experience.
• Advanced degree preferred.

Pay

For US-based candidates, the full and complete base pay range is $140,000.00 – $210,000.00. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The range is reviewed regularly and aligned with the Company’s Total Compensation philosophy and internal equity considerations.

Benefits

The successful candidate may be eligible for a discretionary annual cash bonus or incentive compensation in accordance with the Company’s Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants under Jazz’s Long Term Equity Incentive Plan. Benefits offerings include medical, dental and vision insurance, 401(k) retirement savings plan, and flexible paid vacation. For more information, visit https://careers.jazzpharma.com/benefits.html.