Expert Clinical Research Associate

Summary

Location: Montreal,

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About The Role

We are seeking an Expert Clinical Research Associate with a risk-based and open mindset willing to build and maintain successful site relationships ensuring sustainable trial execution through site management at our research sites.

This role will work directly with the SSO Canada team and reports to the Clinical Research Associate.

About The Role

Key responsibilities:

• 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. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
• 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. Documentation according to GDP and Novartis standards.
• Identifies deficiencies in site processes and monitor site processes performed outside the site, works 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
  
  

Essential

What you’ll bring to the role:

• Decision capability
• Excellent time management and organization capabilities, including ability to prioritize and multi-task
• Risk based mindset (from issue management to risk identification) supported by Novartis systems
• Early adopter and open mindset across borders to support one study approach
• Good knowledge of drug development process specifically clinical trial/research
• Clinical and therapeutic knowledge
• Fluent in English and French, written and spoken French
  
  

Desirable

• Clinical and therapeutic knowledge should include Oncology
  
  

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

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