CRA Senior

• 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 (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 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

• Deliver customer satisfaction results for internal & external customers -Delivery of Clinical Trials to quality standards, agreed timelines, number of patients, costs and quality -Adherence to Novartis policy and guidelines and external regulations

• Minimum 5 years pharmaceutical industry experience in all aspects of monitoring and site management
• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.
• People Leadership.

• Fast change adaptability to best partner & influencing with sites on fast changing landscape
• Trust and rapport building is a very important skill needed
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
• A minimum of 50% overnight travel may be required
• Good communication skills, ability to influence others & Relationship management
• Excellent communicator and presenter (oral and written)
• Ability to manage sites independently; Proven ability to work independently with minimal supervision
• Good analytical thinking
• Ability to anticipate potential issues and take appropriate actions with or without supervision
• Digital & tech capabilities

• English.

Novartis