Global Study Leader
Jazz Pharmaceuticals
August 31, 2026
Remote friendly (California, United States)
United States
Clinical Research and Development
Essential Functions/Responsibilities:
- Provide oversight with the study team and internal/external service providers to ensure study delivery and operational excellence.
- Delegate tasks to study team members.
- Lead implementation, execution, and management of global Phase I–IV clinical trials.
- Lead/facilitate trial-related meetings and ensure cross-functional alignment.
- Escalate cross-functional issues for timely resolution and alignment.
- Participate in program-level discussions (FMT/GPT) with updates to senior management.
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigations to senior leadership.
- Own overall accountability for the Trial Master File (TMF); act as SME for Clinical Operations sections.
- Develop/review trial plans and essential clinical trial documents; review/approve protocols, informed consent forms, monitoring plans, and CSRs per SOPs.
- Oversee study execution including feasibility, planning, vendor selection, patient recruitment, and financial forecasting.
- Plan and support Investigator Meetings.
- Identify/manage risks and contingencies for timelines, quality, and compliance.
- Develop/track trial timelines and budgets; estimate/track/analyze vendor financial spend.
- Oversee external service providers/vendors; ensure quality, compliance, and performance.
- Ensure accurate trial tracking and timely CTMS updates; oversee documentation archiving.
- Serve as trial lead/SME during audits/inspections.
- Coordinate Investigational Medicinal Product (IMP) shipment authorization.
- Assist data query process; review monitoring visit reports (as required).
- Lead/participate in Clinical Operations/GCDO initiatives; serve as SME for process design/review.
- Ensure GCP/SOP compliance and adherence to agreed timelines/protocol.
- Mentor/coaching Global Study Managers, CRAs, and GSAs; lead CTWGs; resolve complex issues; manage high-performing teams.
Required Knowledge, Skills, and Abilities:
- 7+ years clinical research experience; 3+ years in clinical operations leadership; global trial management/portfolio oversight.
- Strong organizational, time-management, attention to detail.
- Excellent written/verbal communication and stakeholder management.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
- Clinical trial electronic systems knowledge (TMF, CTMS, etc.).
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and regulatory start-up planning (SSU).
- Proven cross-functional and global, multi-center trial project management.
- Leadership/governance experience with ability to influence senior levels.
- Travel: 10%–20%.
Education/Licenses:
- Bachelor’s degree (life sciences/healthcare or related) or equivalent experience.
- Advanced degree preferred.
Application instruction:
- If you are a current Jazz employee, apply via the Internal Career site.
- Provide oversight with the study team and internal/external service providers to ensure study delivery and operational excellence.
- Delegate tasks to study team members.
- Lead implementation, execution, and management of global Phase I–IV clinical trials.
- Lead/facilitate trial-related meetings and ensure cross-functional alignment.
- Escalate cross-functional issues for timely resolution and alignment.
- Participate in program-level discussions (FMT/GPT) with updates to senior management.
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigations to senior leadership.
- Own overall accountability for the Trial Master File (TMF); act as SME for Clinical Operations sections.
- Develop/review trial plans and essential clinical trial documents; review/approve protocols, informed consent forms, monitoring plans, and CSRs per SOPs.
- Oversee study execution including feasibility, planning, vendor selection, patient recruitment, and financial forecasting.
- Plan and support Investigator Meetings.
- Identify/manage risks and contingencies for timelines, quality, and compliance.
- Develop/track trial timelines and budgets; estimate/track/analyze vendor financial spend.
- Oversee external service providers/vendors; ensure quality, compliance, and performance.
- Ensure accurate trial tracking and timely CTMS updates; oversee documentation archiving.
- Serve as trial lead/SME during audits/inspections.
- Coordinate Investigational Medicinal Product (IMP) shipment authorization.
- Assist data query process; review monitoring visit reports (as required).
- Lead/participate in Clinical Operations/GCDO initiatives; serve as SME for process design/review.
- Ensure GCP/SOP compliance and adherence to agreed timelines/protocol.
- Mentor/coaching Global Study Managers, CRAs, and GSAs; lead CTWGs; resolve complex issues; manage high-performing teams.
Required Knowledge, Skills, and Abilities:
- 7+ years clinical research experience; 3+ years in clinical operations leadership; global trial management/portfolio oversight.
- Strong organizational, time-management, attention to detail.
- Excellent written/verbal communication and stakeholder management.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
- Clinical trial electronic systems knowledge (TMF, CTMS, etc.).
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and regulatory start-up planning (SSU).
- Proven cross-functional and global, multi-center trial project management.
- Leadership/governance experience with ability to influence senior levels.
- Travel: 10%–20%.
Education/Licenses:
- Bachelor’s degree (life sciences/healthcare or related) or equivalent experience.
- Advanced degree preferred.
Application instruction:
- If you are a current Jazz employee, apply via the Internal Career site.