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Associate Clinical Operations Leader/Reviewer

About the role

• Review clinical site qualification, initiation, monitoring and close-out visit reports for quality, completeness, SOP, ICH-GCP and protocol compliance
• Capture report information in dashboards
• Analyze issues, categories, issue age and recurring trends for the Clinical Operations Leader team
• Identify potential data quality or compliance concerns
• Assess the impact of concerns on study timelines
• Escalate critical issues with recommended solutions
• Communicate study-specific trends and issues to Clinical Operations Leaders
• 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
• Handle potential sponsor-facing responsibilities

• Strong command of written and spoken English and Portuguese 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
• Understanding of 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
• Strong quality focus, analytical thinking, clear communication, sound judgment, and ability to work collaboratively across virtual teams
• Ability to identify issues proactively and prioritize competing needs
• Ability to build trust with internal and external stakeholders
• Very occasional travel for monitoring support may be required

• Professional growth and development opportunities
• Work-life balance
• Flexible working hours
• Fully home-based work in Brazil
• Reduced routine site travel
• Exposure to a world of experiences and open doors
• Career progression toward a Clinical Operations Leader role