Associate Clinical Operations Leader/Reviewer

đŸ”„ 0 minutes ago

đŸ‡§đŸ‡· Brazil – Remote

⏰ Full Time

🟠 Senior

đŸ„ Clinical Operations

đŸ—ŁïžđŸ‡§đŸ‡·đŸ‡”đŸ‡č Portuguese Required

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

💰 Venture Round on 1990-01

Consulting ‱ Healthcare ‱ Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

‱ 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

🎯 Requirements

‱ 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

đŸ–ïž Benefits

‱ 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

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