Are you passionate about managing clinical trial sites and ensuring adherence to regulatory requirements?Do you want to contribute to making Novo Nordisk the preferred partner in clinical trials?If so, we have an exciting opportunity for you to join our team as a Clinical Research Associate (CRA).Apply today for a life-changing career.The Position The CRA is responsible for managing clinical trial sites at every stage of the clinical trial process in accordance with the Company's policies and procedures, relevant legislation, and ICH GCP requirements, whilst maintaining the standards of the Novo Nordisk Way.Main accountabilities of the role: Primary point of contact between site staff and Novo Nordisk, act as a site manager and an ambassador for the company and contributes to making Novo Nordisk the preferred partner in clinical trials; Overall site management, including site monitoring and remote monitoring as applicable; Ensure that trial site staff are properly trained to conduct the trial(s), provide necessary training, and identify and flag any development areas and implement mitigations; Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme; Contribute to or lead selection of sites, in collaboration with CDC and local colleagues such as Line Managers and Medical Affairs.Qualifications To be eligible for this role, you need to hold a bachelor's degree in life science (preferably in Biotechnology, Pharmacy, Chemistry, Biology, CTF) and to have a working experience of a minimum of 1 year of independent monitoring.You also meet the following requirements: You are Fluent in both Italian and English; Knowledge of clinical trial methodology; Good communication skills; Knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs; Good working knowledge of electronic clinical trials systems – CTMS, EDC, IWRS, electronic TMF; Basic GCP qualification.About the Department CDC Italy is part of Region South East Europe, Middle East and Africa (SEEMEA) and is a new set-up of clinical organization in Novo Nordisk Italy.CDC Italy is responsible for conducting clinical trials within the country, providing clinical trial management and administration supporting the local teams.You will work in our Clinical, Medical and Regulatory (CMR) department at Novo Nordisk, that is one of the most diverse and collaborative groups within the organization.From health-care-provider interactions and developing and implementing regulatory strategies, to providing medical education and collecting data to support efficacy and new product development, CMR is involved.In relation to Clinical Operations Italy is organised with a dedicated Clinical Development Centre (CDC) which is part of the CMR department.
