Clinical Start-Up Specialist, CDC PL
Warsaw, Mazowieckie, PL
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 documentation. 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 documentation.
- 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 act as a proactive and independent Start-up Team Member
- 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
The Clinical Start-up Specialist position is based in Poland and is the part of our CDC Poland department. You will report directly to Clinical Operation Manager, Trial Start-up Team, CDC PL and play a crucial role as a submission Specialist. Our department is committed to fostering a collaborative and empowering atmosphere, where high quality of documents and extensive knowledge of submissions are at the forefront. Our team is dedicated to making a significant impact on the global clinical landscape.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.
Contact
Please click on 'Apply Now' to submit your resume in English.
Deadline
Please apply before 22 April 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.