​​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 acts as a primary point of escalation for cross-functional stakeholders. Develops and executes clinical trial strategies in collaboration with cross-functional teams, tracking and reporting trial progress, risks and mitigation strategies to senior leadership. Holds overall accountability for the Trial Master File (TMF) and serves as an SME for Clinical Operations–related sections.

Responsibilities

• Lead, facilitate and delegate trial-related meetings, ensuring alignment with cross-functional teams.
• Participate in program-level discussions (FMT, GPT), providing clear and timely updates to senior management as needed.
• 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 SOPs.
• Contribute to 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, including estimating, tracking and analyzing vendor financial spend.
• Accountable for 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.
• Serve 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; serve 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 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, with proven global trial management and portfolio-level oversight and a 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 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, etc.).
• Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
• Strong knowledge of regulatory start-up process 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.
• 10% to 20% travel.

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 paid within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The range will be reviewed on a regular basis. Discretionary annual cash bonus or incentive compensation and discretionary equity grants may also be available in accordance with Jazz’s Global Cash Bonus Plan, Incentive Compensation Plan, and Long Term Equity Incentive Plan.

Benefits

The successful candidate will be eligible to participate in various benefits offerings, including medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.