Project Manager [Lead CRA]

📋 Description

• Manage and coordinate clinical research project activities within the CRO, ensuring alignment with
• Oversee the preparation, review, control, and submission of regulatory documentation, ensuring
• Ensure that contracted services and clinical trial activities are conducted in accordance with
• Maintain comprehensive knowledge of study protocols, monitoring strategies, safety requirements
• Implement and oversee risk assessment processes, identifying potential operational, regulatory, and
• Define, monitor, and evaluate Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) to

🎯 Requirements

• Bachelor's degree or higher in a health-related field or a related discipline.
• Extensive professional experience in clinical monitoring, with a strong understanding of clinical
• Knowledge of regional regulatory requirements across Latin America (LATAM), including the
• Experience in clinical research project management, including coordinating activities, managing
• Strong understanding of clinical study protocols, monitoring plans, safety plans, regulatory
• Familiarity with risk assessment methodologies, KPIs, KRIs, and processes for identifying

🎁 Benefits

• Contract type: PJ (independent contractor).
• Work arrangement: Remote, with the opportunity to work from Brazil.
• Professional development: Opportunities to strengthen expertise in clinical research project
• Leadership opportunities: Responsibility for coordinating clinical research projects and
• Regional exposure: Professional experience supporting clinical research activities involving Latin
• Meaningful contribution: The opportunity to support high-quality clinical research through