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Clinical Trial Operations Manager
1 week ago
About Novo Nordisk
Novo Nordisk A/S is a dynamic company that drives innovation in the pharmaceutical industry. We are dedicated to developing and delivering life-changing treatments for patients worldwide.
We are seeking an experienced Clinical Trial Submission Manager to join our team, where you will be responsible for leading the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs). As a key member of our CTA Management department, you will collaborate closely with stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale.
- Lead the CTA submission process effectively and apply best practices to ensure timely submission of CTAs.
- E nsure CTA submission is in compliance with all applicable requirements worldwide and drive better practice and consistency across trials.
- Coordinate the preparation and monitoring of CTA documents for submission of initial CTAs and amendments.
- Provide daily support to the team in analysis and problem-solving related to CTA submission activities.
- Provide continuous input to CTA process and system improvements to drive best practice and efficiency gains across CTA submissions.
Required Skills and Qualifications
To succeed in this role, you should possess:
- A Bachelor's or Master's degree in Life Science or a relevant field.
- Experience within the pharmaceutical or medical device industry.
- Project management expertise and experience in managing trials/projects.
- Cross-functional organizational work, representing trial management views.
- Extensive experience in all operational aspects of start-up, planning, conduct, and finalization of CTAs.
