Are you an experienced clinical research professional interested in the start-up and regulatory aspects?Do you need to have things in order, and attention to detail is one of your qualities?If you are ready to make a difference in our clinical department, you might be our new Clinical Start-Up Specialist.Apply today and drive the change with us at Novo Nordisk Clinical Development Centre (CDC) Italy!The Position As a Clinical Start-Up Specialist you will manage and execute start-up activities in the allocated clinical trials in compliance with EU CTR, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements to deliver reliable, high quality data and trial subject protection to activate sites prior global submission of the trial.You will also establish and maintain professional relationships with internal and external stakeholders.Your main accountabilities will be to: Manage Clinical Trial Application activities at country level, defining country Trial Strategy in cooperation with CDC Trial Manager: defining internal timelines to collect and prepare documents for submissions to CTIS Update internal systems for Regulatory Clinical Trials Management Prepare and upload country & site trial documents to internal systems (incl.translation and redaction of new trial documents)Participate in kick-off meetings and Trial TCs with the EUSubmissionHub in HQ and CDC Trial Managers, provide input to submission timelines and monitor and communicate critical issues that may impair trial progress Identify potential risks and proactively take action to prevent or mitigate Represent Novo Nordisk with Health Authorities, Ethical committees or in external working groups and at conferences Qualifications To be effective in this role, we require extensive knowledge of the Local regulation for Clinical Trials, EU CTR and minimum 1 year of experience from a similar position in the pharmaceutical industry of Clinical Research Organisation (CRO) focused on clinical trial submission process in Italy.Fluent Italian and English language skills are also required.Other requirements: IT proficiency: MS Office and clinical trials systems Ability to build and maintain strong working relationships with internal and external stakeholders, team-oriented personality with high degree of flexibility - close collaboration with relevant roles to ensure successful start-up of trials Ability to take ownership of start-up activities to ensure timely submission, proactively flagging risks and issues and providing possible mitigations and solutions Excellent negotiation, communication, and presentation skills High degree of trustworthiness and focus on quality and timely delivery About the Department CDC (Clinical Development Centre) 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.
