Clinical Study Manager

Job Summary

Working remotely in a full-time capacity, the Clinical Study Manager will lead operational strategy and execution for assigned clinical studies, ensuring compliance with quality standards and effective collaboration with strategic partners and vendors.

Key responsibilities:

• Oversee the planning and execution of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements
• Provide operational input into study-related documents and participate in feasibility and site selection processes
• Manage study budgets and external vendor performance, serving as the escalation point for issues and ensuring studies are inspection-ready

Required qualifications:

• BS/BA in a health-related, life science, or technology-related field; advanced degrees are a plus
• 5+ years of experience in the pharmaceutical industry or clinical research, with at least 3 years in clinical study management
• Knowledge of global regulatory and compliance requirements for clinical research, including ICH GCP
• Demonstrated experience in project/program management and matrix leadership
• Fluent in business English, both oral and written