Summary

Supervisa los datos de los pacientes y la información relacionada con el estudio relacionada con los sitios de estudio clínico y la participación en los ensayos clínicos. Garantiza que el investigador se adhiere a los protocolos de investigación, los requisitos reglamentarios y las buenas prácticas clínicas y proporciona información sobre el plan de validación de datos. Proporciona un monitoreo oportuno y preciso de los datos del paciente y la información relacionada con el estudio de los documentos de origen, los registros de investigación y las visitas al sitio cuando corresponda. Pueden monitorear los sitios de estudio y la selección de instalaciones de auditoría.

About the Role

Main Accountabilities

• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.
• Identifies deficiencies in site processes and monitor site processes performed outside the siteworks in close collaboration with site on risks mitigation and process improvements.
• Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
• Identify deficiencies in site process, work in close collaboration with site on risk mitigation.
• Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team.
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.

• Up to 2 years pharmaceutical industry experience or other relevant experience
• Central/in-house monitoring or field monitoring experience is desirable
• Fast change adaptability to best partner & influencing with sites on fast changing landscape
• Ability to manage sites independently; Proven ability to work independently with minimal supervision
• Good analytical thinking
• Ability to anticipate potential issues and take appropriate actions with or without supervision
• Clinical and therapeutic knowledge knowledge of international standards (GCP/ICH, FDA,EMA)
• Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance)