Job Description

Band

Level 3Site 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).Senior Clinical Research Associate (sCRA) is assigned to more complex trials and/or to less experienced sites where applicable. Associate takes on the responsibility as SME (Subject Matter Expert) as needed, 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, and participates in multi-disciplinary teams locally and globally to evaluate and implement process improvements.

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 (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

• Identify deficiencies in site process, work in close collaboration with site on risk mitigation

• 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

Essential Requirements:

• Degree in scientific or healthcare discipline (or, for United States: 4-year degree plus relevant, related healthcare experience )

• Fluent in both written and spoken English and country language

• Minimum 3 years pharmaceutical industry experience or other relevant experience

• Field monitoring experience is desirable

Desirable Requirements:

• Decision capability

• Excellent time management and organization capabilities, including ability to prioritize and multi-task

• Risk based mindset (from issue management to risk identification) supported by Novartis systems

• Early adopter and open mindset across borders to support one study approach

• Good knowledge of drug development process specifically clinical trial/research

• Clinical and therapeutic knowledge

• Knowledge of international standards (GCP/ICH, FDA, EMA)

• Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance)

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences