Overview
We are seeking a highly skilled and experienced Global Clinical Study Manager to lead and oversee international clinical trials within our organization. This pivotal role involves managing all aspects of clinical study execution, ensuring compliance with regulatory standards, and maintaining high-quality data collection and analysis. The successful candidate will play a critical role in advancing our research initiatives, supporting clinical development, and ensuring that studies are conducted efficiently, ethically, and in accordance with global guidelines. This position offers an opportunity to contribute to innovative healthcare solutions on a worldwide scale.
Responsibilities
- 10+ years of experience in Global Clinical Trial Operations with a Bachelor's degree.
- Lead end-to-end clinical study execution, including planning, timelines, budgets, and study documentation.
- Manage cross-functional teams, CROs, vendors, and clinical sites to ensure successful study delivery.
- Oversee CTMS, TMF, EDC, IVRS/IWRS, study monitoring, patient recruitment, and data quality.
- Perform risk assessment, issue escalation, compliance monitoring, and study close-out activities.
- Provide line management, coaching, performance management, and leadership to Clinical Trial Management staff.
- Strong expertise in clinical operations, stakeholder management, project management, and Microsoft Office Suite.
Experience:
- Global Clinical Trial Operations : 8 years (Required)
- end-to-end clinical study execution: 3 years (Required)
- CTMS, TMF, EDC, IVRS/IWRS: 3 years (Preferred)
- risk assessment: 3 years (Preferred)
Work Location: Hybrid remote in New York, NY 10040
