About the Role
This role is responsible for managing and monitoring clinical trials to ensure adherence to protocols, timelines, and regulatory standards, while serving as a key liaison between study sites and the central team.
Responsibilities
- Oversee the initiation, conduct, and closeout of clinical studies at investigative sites
- Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory requirements
- Conduct site selection, qualification, and monitoring visits
- Review source data and case report forms for accuracy and completeness
- Identify and resolve protocol deviations and site performance issues
- Collaborate with cross-functional teams to support trial timelines and data quality
- Prepare and present site monitoring visit reports in a timely manner
- Verify informed consent processes are properly documented and conducted
- Support audit and inspection readiness at clinical sites
- Track and manage essential regulatory documents
- Assist in the development of monitoring plans and visit reports
- Escalate critical issues to project leadership as needed
- Ensure proper storage and accountability of investigational products
- Train site staff on study procedures and protocol requirements
- Coordinate with central laboratories and trial supply teams
- Maintain up-to-date knowledge of clinical operations processes
- Contribute to process improvement initiatives within clinical monitoring
- Support risk-based monitoring strategies and centralized data review
- Participate in investigator meetings and protocol training sessions
- Ensure data queries are resolved in coordination with data management
- Monitor recruitment progress and support enrollment strategies
- Work with medical monitors and safety teams on adverse event follow-up
- Maintain accurate records in clinical trial management systems
- Support inspection-readiness activities across trial sites
- Promote patient safety and data integrity throughout the trial lifecycle
Compensation
Competitive salary and benefits package offered
Work Arrangement
Remote position with potential for travel
Team
Part of the global clinical operations team
Why Consider This Role?
- Opportunity to lead monitoring efforts in high-impact clinical trials
- Work within a supportive, global clinical operations network
- Access to professional development and training resources
- Be part of a company committed to innovation in patient care
Travel Requirements
- Approximately 50% travel is expected, including domestic and international destinations
- Travel frequency may vary based on study phase and site needs
Not specified
