RBQM Specialist/Advisor
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Søborg
Do you want to make a difference in how we setup and oversee clinical trials in Novo Nordisk? Do you agree that by investing time in setting up trials the smartest way, we can safeguard participant safety and ensure data integrity better in a more structured and efficient way? If yes, you are the RQBM Specialist or Advisor we are looking for. Apply now for a life-changing career! The position
We are looking for a RBQM Specialist or Advisor (depending on seniority) to be part of driving and anchoring the implementation and continuous improvement of RBQM. Your key responsibilities will include:
• Drive the discussions and challenge the trial squad members designing the trial and data capture. Together, you will decide which data and processes that are critical and whether any of the associated risks can be mitigated by design.
• Have a key role in developing the monitoring strategy for the trial by bringing together all the relevant skill areas doing monitoring (CRAs, trial managers, data managers, medical staff)
• Support the trials ongoing risk assessment during conduct and ensure learnings are captured for future trials
• Refine how we handle risks in trials to ensure uniformity where appropriate
• Develop the role in Novo Nordisk to become a key stakeholder for the trial squads in ensuring continuous oversight of the trial. This may include create tools, guidance as required to support the SOPs and processes Your daily work will include collaboration with trial squads to implement risk-based mindset to embrace RBQM framework in trial setup and conduct. You will be involved in trials investigating different drugs in different indications, so no days will be similar, and you will get to know many parts of the clinical organisation. Qualifications
To succeed in this role, we expect you to have:
• MSc in natural sciences or similar
• Experience in the pharmaceutical industry, that would be a preference.
• A thorough end-to-end understanding of clinical development for specialist role
• Active experience with RBQM is an advantage
• Professional proficiency in English As a person, you are open minded and a team worker, appreciating cross-cultural work and a great collaborator with stakeholders. You have demonstrated analytical skills and excel at tutoring and you are comfortable yet respectful in challenging trial squad members in critical thinking and quality mindset. About the department
The CMU (Central Monitoring Unit) is a Danish HQ-department in Clinical Drug Development. We define the RBQM framework of Novo Nordisk, support trials in using the RBQM framework, drive behavioural change toward a risk mindset and execute central monitoring together with our sister department in Bangalore.
We are a diverse team working in a hybrid setting with colleagues in four global locations and with diverse backgrounds (CRA/ monitor, trial manager, medical and safety) and a lot of drug development experience, but less RBQM practice, so we are welcoming all opinions and appreciate experience. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily 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 VP, Bo Maach-Møller +45 3079 5437 Deadline
17th May 2023.
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.
We are looking for a RBQM Specialist or Advisor (depending on seniority) to be part of driving and anchoring the implementation and continuous improvement of RBQM. Your key responsibilities will include:
• Drive the discussions and challenge the trial squad members designing the trial and data capture. Together, you will decide which data and processes that are critical and whether any of the associated risks can be mitigated by design.
• Have a key role in developing the monitoring strategy for the trial by bringing together all the relevant skill areas doing monitoring (CRAs, trial managers, data managers, medical staff)
• Support the trials ongoing risk assessment during conduct and ensure learnings are captured for future trials
• Refine how we handle risks in trials to ensure uniformity where appropriate
• Develop the role in Novo Nordisk to become a key stakeholder for the trial squads in ensuring continuous oversight of the trial. This may include create tools, guidance as required to support the SOPs and processes Your daily work will include collaboration with trial squads to implement risk-based mindset to embrace RBQM framework in trial setup and conduct. You will be involved in trials investigating different drugs in different indications, so no days will be similar, and you will get to know many parts of the clinical organisation. Qualifications
To succeed in this role, we expect you to have:
• MSc in natural sciences or similar
• Experience in the pharmaceutical industry, that would be a preference.
• A thorough end-to-end understanding of clinical development for specialist role
• Active experience with RBQM is an advantage
• Professional proficiency in English As a person, you are open minded and a team worker, appreciating cross-cultural work and a great collaborator with stakeholders. You have demonstrated analytical skills and excel at tutoring and you are comfortable yet respectful in challenging trial squad members in critical thinking and quality mindset. About the department
The CMU (Central Monitoring Unit) is a Danish HQ-department in Clinical Drug Development. We define the RBQM framework of Novo Nordisk, support trials in using the RBQM framework, drive behavioural change toward a risk mindset and execute central monitoring together with our sister department in Bangalore.
We are a diverse team working in a hybrid setting with colleagues in four global locations and with diverse backgrounds (CRA/ monitor, trial manager, medical and safety) and a lot of drug development experience, but less RBQM practice, so we are welcoming all opinions and appreciate experience. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily 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 VP, Bo Maach-Møller +45 3079 5437 Deadline
17th May 2023.
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 5.1.2023, 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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