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Brasil
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Project Manager [Lead CRA] based in Brazil.
We are seeking an experienced clinical research professional to lead and coordinate clinical trial activities within a Contract Research Organization (CRO). In this role, you will oversee project execution, ensure regulatory compliance, and help maintain the highest standards of quality and protocol adherence. You will play a key role in managing clinical monitoring activities, coordinating documentation, and ensuring effective communication across project teams. By implementing risk-based strategies and monitoring key performance indicators, you will help identify potential issues and drive continuous improvement. This position combines clinical expertise, project management, and regional regulatory knowledge across Latin America. You will also contribute to internal team training, fostering knowledge sharing and strengthening operational excellence in a remote work environment
Manage and coordinate clinical research project activities within the CRO, ensuring alignment with project objectives, timelines, quality standards, and applicable regulations.
Oversee the preparation, review, control, and submission of regulatory documentation, ensuring accuracy, completeness, and compliance with applicable requirements.
Ensure that contracted services and clinical trial activities are conducted in accordance with approved study protocols, monitoring plans, safety plans, and communication procedures.
Maintain comprehensive knowledge of study protocols, monitoring strategies, safety requirements, and project communication plans to support effective execution.
Implement and oversee risk assessment processes, identifying potential operational, regulatory, and quality risks and developing appropriate mitigation strategies.
Define, monitor, and evaluate Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) to assess project performance, identify deviations, and support proactive decision-making.
Coordinate communication among project stakeholders, clinical research teams, and relevant partners to ensure alignment, timely issue resolution, and consistent information flow.
Monitor clinical trial progress, identify potential delays or compliance concerns, and implement corrective and preventive actions when necessary.
Contribute to the development and delivery of internal training initiatives, sharing clinical research expertise and promoting consistent working practices across the team.
Support continuous improvement initiatives to strengthen project management processes, regulatory compliance, and the overall quality of clinical research operations.
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 trial operations and monitoring practices.
Knowledge of regional regulatory requirements across Latin America (LATAM), including the regulatory considerations relevant to clinical research activities.
Experience in clinical research project management, including coordinating activities, managing timelines, overseeing documentation, and monitoring project performance.
Strong understanding of clinical study protocols, monitoring plans, safety plans, regulatory documentation, and clinical trial compliance requirements.
Familiarity with risk assessment methodologies, KPIs, KRIs, and processes for identifying, evaluating, and mitigating clinical research risks.
Fluency in English, with the ability to communicate effectively with stakeholders in an international clinical research environment.
Spanish proficiency is considered an advantage, particularly for collaboration across Latin American markets.
Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities and address operational challenges proactively.
Excellent communication and stakeholder management skills, with the ability to coordinate cross-functional teams and maintain clear, effective project communication.
A proactive and detail-oriented approach, with a commitment to regulatory compliance, data quality, patient safety, and continuous improvement.
Ability to work independently in a remote environment while contributing effectively to collaborative project teams and internal training activities.
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 management, monitoring, and regional regulatory practices.
Leadership opportunities: Responsibility for coordinating clinical research projects and contributing to team training and knowledge sharing.
Regional exposure: Professional experience supporting clinical research activities involving Latin American regulatory requirements.
Meaningful contribution: The opportunity to support high-quality clinical research through effective project oversight, risk management, and regulatory compliance.
