### **Summary** This is a site relationship management role to ensure sustainable trial execution at site. The CRA will perform on\-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I\-IV GDD trials within Spain in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Responsible for 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. Location: Madrid: Provincial. ### **About the Role** **Key responsibilities but not limited to:** * Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset * Manage assigned study sites, conducting phase I\-IV protocols according to the monitoring plan and Novartis procedures * Perform site initiation visits, ensures site personnel is fully trained on all trial related aspects. * Perform continuous training for amendments and new site personnel as required. * Conduct continuous site monitoring activities (onsite and remote). * Implement site management activities to ensure compliance with protocol, global and local regulation including Health Authorities, data privacy requirements, global and local processes as applicable. * Identify deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements * Promote 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. * Perform Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements * Attend onboarding\-, disease indication and project specific training and general CRA training as required **Essential criteria:** * Degree in scientific or healthcare discipline * Up to 2 years pharmaceutical industry experience or other relevant experience Central / in\-house monitoring or field monitoring experience is desirable **Desirable criteria:** * 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) **Languages:** * Fluent in both written and spoken English and country language **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture **Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network **Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits\-rewards Division Development Business Unit Development Location Spain Site Madrid Provincial Company / Legal Entity ES06 (FCRS \= ES006\) Novartis Farmacéutica, S.A. Functional Area Research \& Development Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.