Major accountabilities:

• Conducts continuous site monitoring activities (onsite and remote) and manages assigned study sites, conducting phase I-IV protocols. 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.
• Performs Site Initiation Visit and Site Closeout activities per SOPs and applicable regulations.
• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
• 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
• 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.
• 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.
• 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.

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

Minimum Requirements:
Work Experience:

• Degree in scientific or healthcare discipline
• Field monitoring experience
• Operations Management and Execution.
• Up to 2 years pharmaceutical industry experience or other relevant experience
• Collaborating across boundaries.

Skills:

• Clinical Monitoring/Research/Trials.
• Fast change adaptability.
• Collaboration.
• Data Integrity.
• Decision Making Skills.
• Ability to travel.
• Good communication skills
• Ability to manage sites independently
• Time management and organization capabilities

Languages :

• English (Written and Spoken).