- Location:
- Warsaw, Masovian, Poland
- Salary:
- Competitive
- Type:
- Permanent
- Main Industry:
- Search Health, Nursing & Social Services Jobs
- Other Industries & Skills:
- Education & Training Information Technology
- Job ID:
- 131496145
- Posted On:
- 10 January 2025
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 Clinical Start Up Specialist. Apply today and drive the change with us at Novo Nordisk!
The Position
As a Clinical 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 professional relationships with internal and external stakeholders.
Your main accountabilities will be to:
-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.
-Establish and maintain professional relationships with internal and external stakeholders.
Qualifications
We need you to have extensive knowledge of EU Clinical Trials Regulations and local regulations along with solid experience in clinical trials submissions process (at least one year of experience with EU CTR submissions). We also require fluent Polish and English language skills.
Other requirements:
-The ability to build and maintain strong working relationships with internal and external stakeholders
-A team-oriented personality with high degree of flexibility – close collaboration with relevant roles to ensure successful start-up of the trial
-High result orienting in driving of start-up milestones according to CDC start-up KPIs
-Ability and willingness to adjust quickly to new situations in a continuously developing environment
-A high degree of trustworthiness, proven decision making and problem-solving capabilities, and a high focus on delivery and quality
About the Department
Region South East Europe, Middle East and Africa (SEEMEA) is a new set up of clinical organization in Novo Nordisk, covering a groupof 20+ countries, organized through 9 Clinical Development Centers (CDCs): CDC Poland (12 countries), CDC Czech Republic, CDC Greece, CDC Italy, CDC Bulgaria, CDC Israel, CDC Russia, CDC South Africa, CDC Turkey (6 countries). CDCs are responsible forconducting clinical trials across respective (group of) countries, providing clinical trial management and administration support to adjacent Affiliates.
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
Please click on ‘Apply Now’ to submit your resume in English.
Deadline
Please apply before Jan 17th, 2025.
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.
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