Expert Cra - Milano, Italia - Novartis

Novartis

Azienda verificata

Milano, Italia

3 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

100,000+ That's how many patients participate in our clinical trials at any given time.

GCO (Global Clinical Operations) is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments.

Every day, we are the link between science and medicine - imagine the impact you could have as Clinical Research Associate in Italy #GCO

Job Purpose:
Site relationship management 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. Retrains 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
Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
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
Attends onboarding, disease indication and project specific training and general CRA training as required
Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality
Ensures that relevant site insights are shared with internal stakeholders such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites
Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date

Activities & Interfaces:

Externally facing role with impact on Principal Investigators and Institution/Site business offices
Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor and site relationship manager to achieve key accountabilities
Actively share insights with relevant internal stakeholder to drive site and account development
Partners with SSU CRA to ensure seamless transition of site responsibility

Key Performance Indicators:

Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results
Meets study milestones
Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements
Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and KQIs

Commitment to Diversity & Inclusion: