About the role

Please note this position can be based in Andalucía, Madrid or the North (País Vasco, La Rioja, Cantabria

The CRA is responsible role to ensure sustainable trial execution at site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH / GCP, local regulations and SOPs.

Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites.

from issue management to risk identification).

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. 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
• Identify deficiencies in site process, work in close collaboration with site on risk mitigation
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.

Commitment to Diversity & Inclusion :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Required Experience

• At least 1 year pharmaceutical industry experience or other relevant experience
• Central / in-house monitoring or field monitoring experience is desirable

This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.