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.
• Implements site management activities to ensure compliance with protocol.
• 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
• Identify deficiencies in site process, work in close collaboration with site on risk mitigation.Establish a strong partnership and true collaboration with the site.Early engagement with site on patient inventory and patient flow in advance
• 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 other relevant business units.Participates in audit organization and inspection readiness activities for monitoring and site.Collaborates with internal stakeholders and site personnel.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