Project Manager [Lead CRA]

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

• 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.