Associate Clinical Operations Leader

• Review site qualification, initiation, monitoring and close-out visit reports for quality, completeness, SOP, ICH-GCP and protocol compliance
• Capture report information in dashboards and analyze issues, categories, issue age and recurring trends for the Clinical Operations Leader team
• Identify potential data quality or compliance concerns, assess impact on study timelines, and escalate critical issues with recommended solutions
• Communicate study-specific trends and issues to Clinical Operations Leaders and support regular trend reporting
• Escalate CRA report-quality or documentation concerns through appropriate line-management channels
• Work under the guidance of an experienced Clinical Operations Leader or Line Manager
• May have sponsor-facing responsibilities

• Strong command of written and spoken English and Spanish required
• Minimum of five years of Senior CRA experience required
• Relevant Clinical Operations Leader or project-lead experience will also be considered
• Strong understanding of the clinical trial process, cross-functional clinical activities, site management, data processing and data cleaning
• Degree in a life science, nursing qualification, or relevant clinical and/or clinical management experience
• Ability to work collaboratively across virtual teams
• Proactive issue identification and prioritization of competing needs
• Ability to build trust with internal and external stakeholders

• Professional growth and development opportunities
• Work-life balance
• Flexible working hours
• Fully home-based work in Mexico or Colombia
• Very occasional travel for monitoring support may be required