Global Study Leader
Jazz Pharmaceuticals
August 31, 2026
Remote friendly (Palo Alto, CA)
United States
Clinical Research and Development
If you are a current Jazz employee please apply via the Internal Career site.
Essential Functions/Responsibilities
- Oversight 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/delegate trial-related meetings; act as primary escalation point for timely issue resolution and cross-functional alignment.
- Participate in program-level discussions (FMT, GPT) and provide timely updates to senior management.
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigation to senior leadership.
- Accountable for Trial Master File (TMF) and serve as SME for Clinical Operations-related sections.
- Develop/review trial-specific plans and essential clinical trial documents; review/approve protocols, informed consent forms, monitoring plans, and CSRs per SOPs.
- Oversee operational oversight and strategy for assigned studies (feasibility, planning, vendor selection, patient recruitment, financial forecasting).
- Support Investigator Meetings; manage risk/contingencies; develop/manage/track timelines and budgets; analyze vendor spend.
- Oversee external vendors/service providers; ensure accurate updates in trial management systems; oversee documentation archiving.
- Serve as trial lead/SME during audits and inspections; coordinate IMP shipment authorization; support data queries; review monitoring reports (as required).
- Lead/participate in Clinical Operations/GCDO initiatives; serve as SME for process design/review.
- Ensure trial activities follow GCP, relevant SOPs, timelines, and protocol.
- Mentor Global Study Managers, CRAs, and GSAs; lead Clinical Trial Working Groups; resolve complex issues and escalate risks; maintain high-performing clinical teams.
Required Knowledge, Skills, and Abilities
- 7+ years clinical research experience; 3+ years in clinical operations leadership.
- Strong organization, communication, stakeholder management, leadership, and project management.
- Proficiency: Microsoft Office; strong knowledge of clinical trial electronic systems (TMF, CTMS, etc.).
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and regulatory start-up planning (SSU).
- Ability to work independently/collaboratively; proven cross-functional and global, multi-center trial management.
- Travel: 10%–20%.
Required/Preferred Education and Licenses
- Bachelor’s degree (life sciences/healthcare/related) or equivalent experience; advanced degree preferred.
For US candidates only
- Base pay range: $140,000.00–$210,000.00; may be eligible for bonus/incentive and equity; benefits may include medical/dental/vision, 401k, and flexible paid vacation.
Essential Functions/Responsibilities
- Oversight 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/delegate trial-related meetings; act as primary escalation point for timely issue resolution and cross-functional alignment.
- Participate in program-level discussions (FMT, GPT) and provide timely updates to senior management.
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigation to senior leadership.
- Accountable for Trial Master File (TMF) and serve as SME for Clinical Operations-related sections.
- Develop/review trial-specific plans and essential clinical trial documents; review/approve protocols, informed consent forms, monitoring plans, and CSRs per SOPs.
- Oversee operational oversight and strategy for assigned studies (feasibility, planning, vendor selection, patient recruitment, financial forecasting).
- Support Investigator Meetings; manage risk/contingencies; develop/manage/track timelines and budgets; analyze vendor spend.
- Oversee external vendors/service providers; ensure accurate updates in trial management systems; oversee documentation archiving.
- Serve as trial lead/SME during audits and inspections; coordinate IMP shipment authorization; support data queries; review monitoring reports (as required).
- Lead/participate in Clinical Operations/GCDO initiatives; serve as SME for process design/review.
- Ensure trial activities follow GCP, relevant SOPs, timelines, and protocol.
- Mentor Global Study Managers, CRAs, and GSAs; lead Clinical Trial Working Groups; resolve complex issues and escalate risks; maintain high-performing clinical teams.
Required Knowledge, Skills, and Abilities
- 7+ years clinical research experience; 3+ years in clinical operations leadership.
- Strong organization, communication, stakeholder management, leadership, and project management.
- Proficiency: Microsoft Office; strong knowledge of clinical trial electronic systems (TMF, CTMS, etc.).
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and regulatory start-up planning (SSU).
- Ability to work independently/collaboratively; proven cross-functional and global, multi-center trial management.
- Travel: 10%–20%.
Required/Preferred Education and Licenses
- Bachelor’s degree (life sciences/healthcare/related) or equivalent experience; advanced degree preferred.
For US candidates only
- Base pay range: $140,000.00–$210,000.00; may be eligible for bonus/incentive and equity; benefits may include medical/dental/vision, 401k, and flexible paid vacation.