Clinical Trial Manager II (Sponsor dedicated) - Experience in project management and previous experience as CRA - Chile Home Based
RemoteChile
Job Summary
Oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol compliance, and data integrity. Manage site interactions from activation through closeout, including recruitment, investigator payments, and risk mitigation. Coordinate with functional leaders to meet enrollment and database lock timelines, while providing status updates and solutions for protocol execution obstacles. Develop and maintain clinical study tools, conduct training on protocol specifics and SOPs, and ensure quality of monitoring documentation and audit trails. Supervise assigned CRAs and Central Monitors, assess compliance, and support inspection readiness.
Required Qualifications
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
- Demonstrated ability to lead and align teams in the achievement of project milestones
- Demonstrated capability of working in an international environment
- Demonstrated expertise in site management and monitoring (clinical or central)
- Must demonstrate good computer skills
- Good communication, presentation and interpersonal skills among project team and with sites
- Strong conflict resolution skills
- Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%
Desired Qualifications
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.