CLINiC Risk Manager
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Gentofte
Do you want to be part of establishing Novo Nordisk’s future Clinical Innovation Centre – CLINiC?
Do you have a strong background in IT, GCP and clinical trials? And are you keen to use your sense of detail and strong quality mindset to ensure that CLINiC is ‘best-in-class’ when it comes to managing potential risks in relation to patient safety, data integrity, security and data protection? If so, then you might be our new CLINiC Risk Manager. Read more and apply today! The position
As a Risk Manager, you are responsible for defining and executing risk management activities that ensure CLINiC patient safety, as well as data security, privacy and integrity. You will be expected to work according to Novo Nordisk Quality Management procedures. You will be reporting to the CLINiC Head of Digitalisation & Quality. It is a growing team, expected to be between 10 and 20 colleagues. Among your daily tasks, you will:
• Ensure structured risk management with safety, data integrity, security and data protection in focus
• Keep up to date with relevant risk management standards/guidance materials e.g., NN SOPs, ICH Q9 and ISO standard 14971
• Establish the formal CLINiC procedure for applying risk management principles
• Author key documents e.g., Risk Management Plans and Reports
• Perform task/process analysis Moreover, you will lead, facilitate and document structured risk management meetings. It is crucial that you are motivated to understand the GCP (Good Clinical Practice), IT and Software as a Medical Device (SaMD) quality spaces. Qualifications
To succeed in the role, you have a passion for operational excellence combined with experience in global clinical drug development, global IT or other adjacent areas. Moreover, you can recognize yourself in the following:
• BSc or MSc degree in life sciences, tech or engineering-related areas
• Deep understanding of software and IT tools used in clinical trials
• 1-2 years’ experience in clinical projects
• Expertise in GCP, verification and validation activities
• Fluency in written and spoken English
Bringing project leadership experience within an expert role is beneficial when driving business-critical initiatives through cross-organizational collaboration.
You are curious, hands-on oriented and analytical by nature. The role requires a considerable amount of self-drive, direction setting and accountability. We emphasize accountability and reaching goals through a collaborative effort; thus, it is essential that you can use your good interpersonal and communication skills to achieve results together with others.
About the department
You will become part of our CLINiC Digitalisation & Quality department located in Gentofte, Denmark. The CLINiC is currently under development and will be responsible for conducting multiple clinical pharmacology trials with a primary focus on First Human Dose and pre-& phase 1 studies of an explorative nature. The CLINiC works closely with various partners within Novo Nordisk as well as externally across the Danish life science ecosystem. 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Head of Digitalisation and Quality Roland Foster +45 3075 2817. Deadline
26 February 2023
If you can recognize yourself in the description above, please apply rather today than tomorrow, as we call for interviews on an ongoing basis and close the position as soon as we find the right candidate.
You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process. 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.
Do you have a strong background in IT, GCP and clinical trials? And are you keen to use your sense of detail and strong quality mindset to ensure that CLINiC is ‘best-in-class’ when it comes to managing potential risks in relation to patient safety, data integrity, security and data protection? If so, then you might be our new CLINiC Risk Manager. Read more and apply today! The position
As a Risk Manager, you are responsible for defining and executing risk management activities that ensure CLINiC patient safety, as well as data security, privacy and integrity. You will be expected to work according to Novo Nordisk Quality Management procedures. You will be reporting to the CLINiC Head of Digitalisation & Quality. It is a growing team, expected to be between 10 and 20 colleagues. Among your daily tasks, you will:
• Ensure structured risk management with safety, data integrity, security and data protection in focus
• Keep up to date with relevant risk management standards/guidance materials e.g., NN SOPs, ICH Q9 and ISO standard 14971
• Establish the formal CLINiC procedure for applying risk management principles
• Author key documents e.g., Risk Management Plans and Reports
• Perform task/process analysis Moreover, you will lead, facilitate and document structured risk management meetings. It is crucial that you are motivated to understand the GCP (Good Clinical Practice), IT and Software as a Medical Device (SaMD) quality spaces. Qualifications
To succeed in the role, you have a passion for operational excellence combined with experience in global clinical drug development, global IT or other adjacent areas. Moreover, you can recognize yourself in the following:
• BSc or MSc degree in life sciences, tech or engineering-related areas
• Deep understanding of software and IT tools used in clinical trials
• 1-2 years’ experience in clinical projects
• Expertise in GCP, verification and validation activities
• Fluency in written and spoken English
Bringing project leadership experience within an expert role is beneficial when driving business-critical initiatives through cross-organizational collaboration.
You are curious, hands-on oriented and analytical by nature. The role requires a considerable amount of self-drive, direction setting and accountability. We emphasize accountability and reaching goals through a collaborative effort; thus, it is essential that you can use your good interpersonal and communication skills to achieve results together with others.
About the department
You will become part of our CLINiC Digitalisation & Quality department located in Gentofte, Denmark. The CLINiC is currently under development and will be responsible for conducting multiple clinical pharmacology trials with a primary focus on First Human Dose and pre-& phase 1 studies of an explorative nature. The CLINiC works closely with various partners within Novo Nordisk as well as externally across the Danish life science ecosystem. 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Head of Digitalisation and Quality Roland Foster +45 3075 2817. Deadline
26 February 2023
If you can recognize yourself in the description above, please apply rather today than tomorrow, as we call for interviews on an ongoing basis and close the position as soon as we find the right candidate.
You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process. 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 "Administrativ medarbejder", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 9.1.2023, 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.
- Administrativ medarbejder
- Gentofte
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