Summary

Location: Hybrid (both field and office)

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).

This position reports to the Clinical Research Associate (CRA) Manager.

About the Role

• Frontline liaison between Novartis and sites to ensure successful collaboration. 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.
• 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.

• Min 3 years of experience in Clinical Research from Pharma. (Primari monitor role)
• Proficient Hungarian and English, both written and spoken.
• Time management.
• Operations Management and Execution.
• Representing the organization.
• Collaborating across boundaries.
• Project Management.

• Life Sciences degree. (Pharmacist or Biologist)