​​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 point of escalation for cross-functional stakeholders.

Responsibilities

• Delegate tasks to study team members and lead trial-related meetings to ensure alignment with cross-functional teams.
• Develop and execute clinical trial strategies, track progress, risks and mitigation strategies, and report to senior leadership.
• Hold overall accountability for the Trial Master File (TMF) and act as a subject-matter expert for Clinical Operations–related sections.
• Lead the development and review of trial-specific plans and essential documents, including protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs) in line with SOPs.
• Contribute to 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 risk and contingencies to safeguard timelines, quality and compliance.
• Develop, manage and track trial timelines and budgets; estimate, track and analyze 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 in compliance with regulatory and company requirements.
• Serve as trial lead and SME during audits and inspections; coordinate IMP shipment authorization with regulatory and clinical supplies functions.
• Assist and support data query process and perform monitoring visit report review as required.
• Lead and participate in Clinical Operations / Global Clinical Development Operations initiatives; serve as a Clinical Operations SME in process design and review.
• 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) and resolve complex trial issues, escalating risks appropriately.
• Manage and maintain high-performing clinical teams.

Required Knowledge, Skills, and Abilities

• 7+ years of clinical research experience with proven global trial management and portfolio-level oversight, including at least 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, including Study Start-Up planning.
• Proven track record of effectively managing in a cross-functional environment and leading global, multi-center clinical trials.
• Strong leadership and governance experience with the ability to influence at senior levels.
• 10% to 20% travel required.

Required/Preferred Education and Licenses

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

Pay

For this role, 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, with internal equity considerations also influencing decisions. The range is reviewed on a regular basis.

The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation in accordance with Jazz’s Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants under the Long Term Equity Incentive Plan.

Benefits

• Medical, dental and vision insurance
• 401k retirement savings plan
• Flexible paid vacation