REQ-10080974
6月 25, 2026
Argentina
摘要
Planificación, ejecución e interpretación de la investigación de ensayos clínicos, actividades de recopilación de datos y operaciones clínicas. Puede interactuar con sitios de investigación, consultores clínicos, organizaciones de investigación por contrato y otros proveedores. Colabora con colegas médicos/ clínicos del país, equipos clínicos globales y dirige actividades para ejecutar y entregar los estudios asignados. Monitorea los datos de los pacientes y la información relacionada con el estudio relacionada con los sitios de estudio clínico y la participación en ensayos clínicos. Asegura que el investigador se adhiera a los protocolos de investigación, los requisitos reglamentarios y las buenas prácticas clínicas y proporciona información en el plan de validación de datos. Proporciona un monitoreo oportuno y preciso de los datos de los pacientes y la información relacionada con el estudio de los documentos de origen, los registros de investigación y las visitas al sitio cuando corresponda. Puede monitorear los sitios de estudio y la selección de las instalaciones de auditoría.
About the Role
Key Responsibilities
- Lead site relationship management to support successful execution of Phase I through Phase IV trials
- Serve as the frontline liaison between Novartis and assigned investigative sites
- Manage complex study sites according to monitoring plans, procedures, and regulatory requirements
- Conduct site initiation visits and ensure site staff are trained on trial requirements
- Perform ongoing onsite and remote monitoring to ensure compliance and data integrity
- Identify site risks, process gaps, and improvement opportunities to support trial quality
- Promote a strong compliance culture focused on patient safety and ethical trial conduct
- Partner with cross-functional stakeholders to support recruitment, site development, and data quality
- Support audit and inspection readiness, including timely implementation of corrective actions
- Mentor junior Clinical Research Associates and contribute to innovative monitoring practices
Essential Requirements
- Degree in a scientific or healthcare discipline or equivalent relevant industry experience
- Minimum four years of experience in clinical monitoring and site management within the pharmaceutical industry
- Strong knowledge of clinical trial processes and drug development lifecycle
- In-depth understanding of international regulations including Good Clinical Practice and regulatory requirements
- Proven ability to independently manage complex clinical trial sites and monitoring activities
- Strong risk identification and issue management capabilities with a proactive, solutions-oriented approach
- Excellent communication, stakeholder engagement, and influencing skills across cross-functional teams
- Fluency in written and spoken English and local language
Desirable Requirements
- Field monitoring experience across complex or innovative clinical trial designs
- Experience supporting or mentoring junior Clinical Research Associates in a global environment
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Development
Development
Argentina
Ramallo (Argentina)
AR01 (FCRS = AR001) Novartis Argentina S.A.
Research & Development
Full time
Regular
No
