Senior Global Trial Manager, Late-Phase, Remote

Lifelancer Ltd; États-Unis; À distance; USD 120 000 - 173 000; Plein temps

Résumé du poste

IQVIA is seeking a Senior Global Trial Manager to lead late-phase studies in a single sponsor setting. The role is home-based with international scope, requiring strong cross-functional collaboration across data management, drug supply, regulatory, and medical writing.

You will own study delivery, ensure timelines and budgets are met, and oversee TMF readiness, safety updates, and regulatory submissions while championing data quality and real-world evidence generation.

Qualifications

• Experience managing Phase IV, PASS, PAES, or NIS trials.
• Proven ability to lead protocol development and trial startup.
• Strong regulatory writing experience.
• Excellent communication and collaboration skills.
• Deep understanding of GCP and clinical trial design.

Responsabilités

• Draft sections of protocols, CRFs, training materials, and data review plans.
• Oversee data review and TMF audit readiness.
• Forecast and manage investigational product supply.
• Support study closeout, issue resolution, and lifecycle budget tracking.
• Coordinate CRO/vendor selection and performance.

Connaissances

Global trial management

Protocol development

Regulatory writing

Communication skills

GCP knowledge

Formation

Advanced degree in life sciences or healthcare

Description du poste

IQVIA is seeking a Senior Global Trial Manager to lead late-phase studies in a single sponsor setting. The role is home-based with international scope, requiring strong cross-functional collaboration across data management, drug supply, regulatory, and medical writing.

You will own study delivery, ensure timelines and budgets are met, and oversee TMF readiness, safety updates, and regulatory submissions while championing data quality and real-world evidence generation.