Global Study Leader
Jazz Pharmaceuticals
August 31, 2026
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
If you are a current Jazz employee please apply via the Internal Career site.
Essential Functions/Responsibilities
- Oversee study delivery with the study team and internal/external service providers to 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/delegate trial-related meetings; ensure cross-functional alignment
- Escalate issues for timely resolution and alignment
- Participate in program-level discussions (FMT, GPT) and provide updates to senior management
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigation
- Own the Trial Master File (TMF) as an SME for Clinical Operations
- Develop/review trial-specific plans and essential clinical trial documents
- Review/approve key documents (protocols, informed consent forms, monitoring plans, CSRs) per SOPs
- Contribute to study oversight and direction (feasibility, planning, vendor selection, recruitment, financial forecasting)
- Plan and support Investigator Meetings
- Proactively manage risk and contingencies to protect timelines, quality, and compliance
- Manage/track timelines and budgets; estimate/track vendor financial spend
- Oversee external service providers/vendors for quality, compliance, and performance
- Ensure accurate/timely updates in trial management systems
- Oversee final approval and compliance of trial documentation archiving
- Serve as trial lead/SME during audits and inspections
- Coordinate Investigational Medicinal Product (IMP) shipment authorization
- Support data query process; review monitoring visit reports (as required)
- Lead/participate in Clinical Operations/GCDO initiatives (as assigned)
- Ensure trials are conducted per GCP, SOPs, timelines, and protocol
- Mentor Global Study Managers (GSMs), CRAs, and GSAs; lead CTWGs; resolve complex issues; maintain high-performing teams
Required Knowledge, Skills, and Abilities
- 7+ years clinical research experience; 3+ years in clinical operations leadership; global trial management and portfolio oversight
- Excellent organization, time management, detail, and written/verbal communication; strong stakeholder management
- Ability to work independently and collaboratively in a fast-paced environment
- Microsoft Office proficiency (Word, Excel, Outlook, PowerPoint)
- Clinical trial electronic system knowledge (e.g., TMF, CTMS)
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and study start-up planning (SSU)
- Proven cross-functional and project management leadership for global, multi-center trials
- Strong leadership/governance; influence at senior levels
- 10%–20% travel
Required/Preferred Education and Licenses
- Bachelor’s degree (life sciences/healthcare or related) or equivalent experience
- Advanced degree preferred
Essential Functions/Responsibilities
- Oversee study delivery with the study team and internal/external service providers to 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/delegate trial-related meetings; ensure cross-functional alignment
- Escalate issues for timely resolution and alignment
- Participate in program-level discussions (FMT, GPT) and provide updates to senior management
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigation
- Own the Trial Master File (TMF) as an SME for Clinical Operations
- Develop/review trial-specific plans and essential clinical trial documents
- Review/approve key documents (protocols, informed consent forms, monitoring plans, CSRs) per SOPs
- Contribute to study oversight and direction (feasibility, planning, vendor selection, recruitment, financial forecasting)
- Plan and support Investigator Meetings
- Proactively manage risk and contingencies to protect timelines, quality, and compliance
- Manage/track timelines and budgets; estimate/track vendor financial spend
- Oversee external service providers/vendors for quality, compliance, and performance
- Ensure accurate/timely updates in trial management systems
- Oversee final approval and compliance of trial documentation archiving
- Serve as trial lead/SME during audits and inspections
- Coordinate Investigational Medicinal Product (IMP) shipment authorization
- Support data query process; review monitoring visit reports (as required)
- Lead/participate in Clinical Operations/GCDO initiatives (as assigned)
- Ensure trials are conducted per GCP, SOPs, timelines, and protocol
- Mentor Global Study Managers (GSMs), CRAs, and GSAs; lead CTWGs; resolve complex issues; maintain high-performing teams
Required Knowledge, Skills, and Abilities
- 7+ years clinical research experience; 3+ years in clinical operations leadership; global trial management and portfolio oversight
- Excellent organization, time management, detail, and written/verbal communication; strong stakeholder management
- Ability to work independently and collaboratively in a fast-paced environment
- Microsoft Office proficiency (Word, Excel, Outlook, PowerPoint)
- Clinical trial electronic system knowledge (e.g., TMF, CTMS)
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and study start-up planning (SSU)
- Proven cross-functional and project management leadership for global, multi-center trials
- Strong leadership/governance; influence at senior levels
- 10%–20% travel
Required/Preferred Education and Licenses
- Bachelor’s degree (life sciences/healthcare or related) or equivalent experience
- Advanced degree preferred