Global Study Leader
Jazz Pharmaceuticals
2 hours ago
Remote friendly (California, United States)
United States
Clinical Research and Development
Application: If you are a current Jazz employee, apply via the Internal Career site.
Essential Functions/Responsibilities:
- Lead implementation, execution, and management of global Phase I–IV clinical trials.
- Provide oversight for study delivery and operational excellence; delegate tasks to study team members.
- Lead/facilitate trial-related meetings; act as primary escalation point for cross-functional issue resolution.
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigation to senior leadership.
- Own Trial Master File (TMF); serve as SME for Clinical Operations sections; approve trial documents (protocols, informed consent forms, monitoring plans, CSRs) per SOPs.
- Oversee feasibility, planning, vendor selection, patient recruitment strategies, and financial forecasting.
- Manage budgets/timelines; estimate, track, and analyze vendor financial spend.
- Oversee external service providers/vendors; ensure trial tracking updates in trial management systems.
- Oversee documentation archiving; serve as trial lead/SME during audits/inspections.
- Coordinate IMP shipment authorization; assist with data queries; review monitoring visit reports (as required).
- People management: mentor/coaching; lead Clinical Trial Working Groups (CTWGs); resolve complex issues; maintain high-performing teams.
Required Knowledge/Skills:
- Global trial management/portfolio oversight with clinical operations leadership experience.
- Strong organizational, communication, stakeholder management, and project management skills.
- Knowledge of clinical trial processes, ICH-GCP, regulatory requirements; SSU/start-up planning.
- Proficiency in Microsoft Office; experience with clinical trial electronic systems (e.g., TMF, CTMS).
Education:
- Bachelor’s degree (life sciences/healthcare or related) or equivalent; advanced degree preferred.
Benefits (US candidates): May be eligible for bonus/incentive, discretionary equity, and benefits such as medical/dental/vision, 401k, and flexible paid vacation.
Essential Functions/Responsibilities:
- Lead implementation, execution, and management of global Phase I–IV clinical trials.
- Provide oversight for study delivery and operational excellence; delegate tasks to study team members.
- Lead/facilitate trial-related meetings; act as primary escalation point for cross-functional issue resolution.
- Develop and execute clinical trial strategies; track/report progress, risks, and mitigation to senior leadership.
- Own Trial Master File (TMF); serve as SME for Clinical Operations sections; approve trial documents (protocols, informed consent forms, monitoring plans, CSRs) per SOPs.
- Oversee feasibility, planning, vendor selection, patient recruitment strategies, and financial forecasting.
- Manage budgets/timelines; estimate, track, and analyze vendor financial spend.
- Oversee external service providers/vendors; ensure trial tracking updates in trial management systems.
- Oversee documentation archiving; serve as trial lead/SME during audits/inspections.
- Coordinate IMP shipment authorization; assist with data queries; review monitoring visit reports (as required).
- People management: mentor/coaching; lead Clinical Trial Working Groups (CTWGs); resolve complex issues; maintain high-performing teams.
Required Knowledge/Skills:
- Global trial management/portfolio oversight with clinical operations leadership experience.
- Strong organizational, communication, stakeholder management, and project management skills.
- Knowledge of clinical trial processes, ICH-GCP, regulatory requirements; SSU/start-up planning.
- Proficiency in Microsoft Office; experience with clinical trial electronic systems (e.g., TMF, CTMS).
Education:
- Bachelor’s degree (life sciences/healthcare or related) or equivalent; advanced degree preferred.
Benefits (US candidates): May be eligible for bonus/incentive, discretionary equity, and benefits such as medical/dental/vision, 401k, and flexible paid vacation.