Start-up Specialist

Are you a person who is good at managing professional relationships? 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 Start-up Specialist. Apply today and drive the change with us at Novo Nordisk. This position is based in Prague.

The Position

As a Start-up Specialist you will manage and execute the start-up activities in the allocated clinical trials in compliance with local regulations, Novo Nordisk procedures and protocol requirements to deliver reliable, high-quality data and study subject protection to activate sites prior First Patient First Visit in the country. You will also establish and maintain the professional relationships with internal and external stakeholders.

Your main accountabilities will be:

• Manage and execute the 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 study subject protection to activate sites prior global submission of the trial.
• Prepare Part II and selected Part I documents for submission (incl. translation and redaction) and to handover the CTA package to EU Submission Hub within selected timelines.

• Update COSMOS (site and contact set-up), prepare and upload country & site trial documents to Veeva Vault, both until submission. Prepare documents for submission and to handover the CTA package to EU Submission Hub.
• Participate in kick-off meetings and trial TCs with the EU Submission Hub and CDC Trial Managers. Provide input to submission timelines to EU Submission Hub and CDC Trial Manager.
• Cooperate and communicate to EU Submission Hub and CDC Trial Manager any critical issues that may impair trial progress. Identify potential risks and proactively take action to prevent or mitigate.

Qualifications

To be effective in this role we need you to have at least 1 year of experience in trial submissions from a similar position in the pharmaceutical industry or Clinical Research Organisation in performing RA/EC submissions of clinical trials and in-depth experience in clinical operation processes and end-to-end clinical trial conduct.

• Master’s degree in life or natural science.
• Knowledge of clinical trials.
• Fluent Czech and English language.

• 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 the trial.
• Takes ownership of start-up activities to ensure timely submittion and FPFV (First Patient First Visist), proactively flags risk and issues and provides possible mitigations and solutions.
• High result orienting in driving of start-up milestones according to CDC start-up KPIs with excellent negotiation, communication & presentation skills.
• Ability and willingness to adjust quickly to new situations in a continuously developing environment.

As a person, you possess high degree of trustworthiness. Proven decision making and problem-solving capabilities, and good organizational and negotiation skills.

About the Department

The Czech branch has the ambition to improve the quality of life of patients and bring innovations to the markets. We employ 80 employees in Czech Republic, the office is in Prague. Basic facts about Novo Nordisk in the Czech Republic: antidiabetic drugs account for approximately 80% of the company's turnover, most of the DIA portfolio consists of various types of insulin as well as injectable non-insulin preparations for the treatment of diabetes and aids for their application.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

For further information please apply with your CV via the online recruitment system.

We thank all applicants for their interest, however only those candidates selected for interviews will be contacted.

Deadline

Applications until 29th of April 2024

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.