Clinical Operations Lead
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Søborg
Do you want to be part of a large, committed global clinical development team that plays a crucial role in the ambitious medical device and drug development programs at Novo Nordisk? Are you motivated by bringing new innovative treatments to people living with chronic diseases worldwide, and do you wish for a career in a world-leading pharma company that offers great opportunities for personal and professional development? Then you could be our new Clinical Operations Lead. Apply now for a life-changing career! The position
As a Clinical Operations Lead, you take on a senior role with extensive responsibilities, being accountable for all aspects of the operational start-up and initiation activities of a clinical trial. Your main responsibilities will include:
• Define, set-up and prepare our clinical trials with medical devices with operational excellence to the benefit of participants and the company.
• Be a strong contributor towards translating our strategies and aspirations into operational actions and excellence.
• Assume accountability for the start-up and initiation of 1-2 clinical trials depending on complexity.
• Be accountable for trial start-up activities from protocol outline to successful patient recruitment with great exposure to the organisation and cross-functional stakeholders (e.g., Strategic Project Teams, Trial Squads, Medical and Science Teams, Regulatory Affairs etc.)
Qualifications
You will be a great asset to our team because you have:
• A MSc in Natural Science and five years of relevant experience, or a BSc in Natural Science or equivalent with at least seven years of relevant experience (e.g. GTM, CRA, RTM, study nurse or CTA)
• Strong clinical project management experience and the ability to impact the execution and improvement of core clinical processes.
• Knowledge and experience in clinical trial methodology and operational aspects of trial initiation including solid knowledge and experience in clinical IT systems (e.g. EDC, IWRS/RTSM etc)
• Specific experience with device development, ISO14155 and MDR will be an advantage.
• Excellent planning, communication, coordination, and collaboration skills.
• Professional proficiency in English. About the department
In our project area we cover the entire spectrum of clinical development activities within the Obesity, Liver Diseases and Device areas from early phase 1 trials to larger phase 3a programs and phase 3b/4 life cycle management activities on our marketed products. In addition, our project area conducts clinical trials with medical devices, both stand-alone and combined and late-stage usability testing of medical devices and SaMD. This means you may work on both large scale and smaller trials, and with colleagues across our global organization. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a world-leading agile company in a dynamic industry, and we know that what got us to where we are today is not necessary what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Seema S. Wrisberg, Director of Clinical Operations on +45 3448 5319 ([email protected]). Deadline
20 August 2023. Screening and interviewing will be done on an ongoing basis.
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.
As a Clinical Operations Lead, you take on a senior role with extensive responsibilities, being accountable for all aspects of the operational start-up and initiation activities of a clinical trial. Your main responsibilities will include:
• Define, set-up and prepare our clinical trials with medical devices with operational excellence to the benefit of participants and the company.
• Be a strong contributor towards translating our strategies and aspirations into operational actions and excellence.
• Assume accountability for the start-up and initiation of 1-2 clinical trials depending on complexity.
• Be accountable for trial start-up activities from protocol outline to successful patient recruitment with great exposure to the organisation and cross-functional stakeholders (e.g., Strategic Project Teams, Trial Squads, Medical and Science Teams, Regulatory Affairs etc.)
Qualifications
You will be a great asset to our team because you have:
• A MSc in Natural Science and five years of relevant experience, or a BSc in Natural Science or equivalent with at least seven years of relevant experience (e.g. GTM, CRA, RTM, study nurse or CTA)
• Strong clinical project management experience and the ability to impact the execution and improvement of core clinical processes.
• Knowledge and experience in clinical trial methodology and operational aspects of trial initiation including solid knowledge and experience in clinical IT systems (e.g. EDC, IWRS/RTSM etc)
• Specific experience with device development, ISO14155 and MDR will be an advantage.
• Excellent planning, communication, coordination, and collaboration skills.
• Professional proficiency in English. About the department
In our project area we cover the entire spectrum of clinical development activities within the Obesity, Liver Diseases and Device areas from early phase 1 trials to larger phase 3a programs and phase 3b/4 life cycle management activities on our marketed products. In addition, our project area conducts clinical trials with medical devices, both stand-alone and combined and late-stage usability testing of medical devices and SaMD. This means you may work on both large scale and smaller trials, and with colleagues across our global organization. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a world-leading agile company in a dynamic industry, and we know that what got us to where we are today is not necessary what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Seema S. Wrisberg, Director of Clinical Operations on +45 3448 5319 ([email protected]). Deadline
20 August 2023. Screening and interviewing will be done on an ongoing basis.
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.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 21.7.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Søborg
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