Clinical Research Associate

Novartis Farmacéutica; Milano; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a Clinical Research Associate in Milano, Italy. The role involves executing and monitoring clinical trials, ensuring compliance with regulatory standards, and managing relationships with study sites. Candidates should have a degree in scientific disciplines, relevant CRA experience, and proficiency in Italian and English. The position promises an engaging work environment committed to improving lives through innovative medicines.

Competenze

• At least 1 year of CRA experience in pharma or CRO.

Mansioni

• Monitor clinical trials and ensure compliance with protocols.
• Manage site performance and act as the liaison between Novartis and study sites.
• Conduct training and continuous monitoring of trial procedures.

Conoscenze

Fluency in Italian

Good English knowledge

Travel willingness

Formazione

Degree in scientific disciplines

Descrizione del lavoro

The Clinical Research Associate (CRA) ensures the sustainable execution of clinical trials at the site level. They perform on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, adhering to monitoring procedures, ICH / GCP guidelines, local regulations, and SOPs.

The CRA proactively manages site performance (recruitment and quality), identifies site needs and issues early, and acts as the primary point of contact internally and externally for all sites.

About the Role

Key Responsibilities include, but are not limited to:

• Acting as the frontline liaison between Novartis and the study sites to ensure successful collaboration, meeting milestones and deliverables with ownership mindset.
• Managing assigned study sites, conducting Phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performing Site Initiation Visits, ensuring site personnel are fully trained on trial aspects, and providing ongoing training for amendments and new staff.
• Conducting continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identifying process deficiencies, collaborating with sites on risk mitigation and process improvements.
• Promoting a culture of compliance, human subject protection, and data integrity.
• Building strong partnerships with sites to increase patient recruitment and reduce issues.
• Engaging early with sites on patient inventory and flow in collaboration with the global and local study teams.
• Managing Site Closeout activities per SOPs and regulations, ensuring proper follow-up and archiving.
• Collaborating with project managers, medical staff, and other stakeholders to optimize recruitment and data quality.
• Participating in audits and inspection readiness activities, implementing corrective actions as needed.
• Qualifications include a degree in scientific disciplines, at least 1 year of CRA experience in pharma or CRO, fluency in Italian, good English knowledge (B2), and willingness to travel across Italy.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend lives. We value our people, who drive us toward our goals. Join us to be part of this mission!

Learn more about our benefits, diversity, and inclusion initiatives, and how to stay connected through our network and talent community.

Role Reference: J-18808-Ljbffr

Position: Clinical Research Associate • Milano, Italia