Senior Event Adjudication Professional
Novo Nordisk US
Are you motivated by the opportunity to drive collaboration with Clinical Research Organisations (CROs) and understand internal stakeholder needs? Would you like to collaborate with specialised scientists and interact with stakeholders across the organisation? Do you want to join a divers and high performing international team in a fast-growing company as Novo Nordisk?
If yes, then this is your opportunity to join a fantastic team in a fast-developing area. We are looking for 2 Event Adjudication Senior Professionals in Søborg, Denmark. Apply now for a life changing career!
Event Adjudication is a process where independent medical specialists assess selected (adverse) events with the purpose of generating high quality data for our clinical trials to the benefit of our patients.
The process is driven out of our Event Adjudication Department in close collaboration with internal stakeholders as well as external Clinical Research Organisations (CROs). As a team, we are responsible for implementing, driving, and overseeing the event adjudication process in all phases of our clinical trials - from set-up and conduct to closure. Joining our team will provide you with a unique opportunity to gain a deep understanding of the key processes involved in our clinical trials.
This is a data driven process that extends across a multitude of both internal and external IT systems. We use business intelligence tools for visualising data to maintain oversight of the process. This means that using and providing input to the improvement of IT systems is an integral part of all roles in our area.
Event adjudication is an important part of conducting clinical trials at Novo Nordisk and as an Event Adjudication Senior Professional you will use project manager capabilities to lead event adjudication activities in assigned clinical trials.
Your main responsibilities will include:
- Leading strong collaboration among stakeholders, including Medical & Science, Data Management, Trial Management, Biostatistics, Affiliate colleagues, and external CROs
- Setting up comprehensive processes for event adjudication, ensuring efficient and accurate handling of clinical trial data
- Vendor selection in close collaboration with Outsourcing, oversight of the performance of external CROs, ensuring adherence to quality standards and timelines
- Compliance & quality - ensuring audit & inspection readiness
- Maintaining an ongoing overview of event numbers by tracking them in reports and utilizing business intelligence tools for data visualization
- Ensuring effective communication with relevant stakeholders, addressing any process issues that may arise, and managing closure activities and archiving
Furthermore, it is expected from you to contribute to optimization activities within the department and participate in cross-functional improvement and innovation projects.
Do you have solid knowledge of clinical trials and experience with project management?
Can you drive collaboration with CROs, understand internal stakeholder needs and do you have a strong process mindset?
To thrive in this role, you ideally have a Master’s degree, preferably within natural or health sciences, technical sciences, engineering or similar.
Other success criteria include:
- Knowledge of clinical trial conduct, Good Clinical Practice (GCP) and flair for project management
- Experience working with CROs is an advantage
- Experience in working with databases and reporting tools, and ability to quickly acquaint with and master new IT systems
- Strong proficiency in English
- Strong MS Office skills; specifically, with Excel
As a person you are proactive, open-minded, dynamic, and eager to learn, and have quality mind-set, excellent collaborative skills, positive attitude towards changes and challenges, as well as ability to work both independently and in a team. Furthermore, it is expected from you to have a high degree of flexibility, a keen interest in coordination and planning, and effectively leading others in project management.
About the department
The Event Adjudication area consists of three departments with a total of 30 highly engaged team members from various academic backgrounds. We are part of Safety Operations, one of the functional areas in Global Safety. Two of the departments are based in Søborg in Denmark, and one is in Bangalore in India.
Our work environment is dynamic, and we are involved in an increasing number of trials in the late-stage clinical development phase and exiting new acquisitions, where clinical events require adjudication.
We have an informal office culture where humour and good relations are valued as we believe it promotes collaboration, conversation, knowledge sharing and teamwork, which are essentials in our job.
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.
For further information about the job please contact Department Manager Kirsten Bang Rungby (+45 3079 6242).
18 February 2024.
We encourage you to apply as soon as possible, as interviews will be held on an ongoing basis.
You do not need to attach a cover letter to your application, but please include a few sentences about your motivation for applying for this position in your resume or CV.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your application.
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.