Clinical Start Up Specialist, Cdc Poland
2 settimane fa
**The Position**
Your main accountabilities will be to:
- Manage and execute the start-up activities in the allocated clinical trial in compliance with EU CTR, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements
- Manage ongoing trials - performing submissions (including translation/redaction of documents), CONNECT, RIM, COSMOS updates
- Prepare Part II and selected Part I documents for submission (including translation and redaction) and to handover the CTA package to EU submission HUB within selected timelines - completion of EMA templates, obtain local insurance certificate
- Check the completeness and correctness of all documents/materials for SIV in close collaboration with the CRA and CDC Clinical Trial Administrator
- Participate in kick-off meetings and trial TCs with the EU submission Hub and CDC Clinical Start Up Trial Managers
**Qualifications**
To be effective in this role we need you to have min. 2 years of experience in clinical operations start-up and submissions. Along with fluent English and Italian 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**
CDC Poland is part of Region South-East Europe, Middle East and Africa (SEEMEA) and is a new set up of clinical organization in Novo Nordisk Poland, covering a group of 16 countries including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, North Macedonia, Italy, Romania, Serbia, Slovakia, Slovenia and Poland. CDC Poland is responsible for conducting clinical trials across this group of countries, providing clinical trial management and administration support to adjacent Affiliates. CDC Poland is currently responsible for approximately 20% of global patients in Novo Nordisk clinical trials.
**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**
**Deadline**
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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