Are you passionate about drug development and do you want to be part of an international team in a fast-developing area dedicated to ensuring high quality data for our clinical trials?
Do you have extensive knowledge of clinical trials and strong project management skills?
Can you lead collaboration with Clinical Research Organisations (CROs) and use your strong process mindset in optimisation and innovation projects in collaboration with internal stakeholders?
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Then you might be the new Event Adjudication Specialist to join our great team. Apply now!
The position
Event adjudication is an important part of conducting clinical trials at Novo Nordisk. As an Event Adjudication Specialist, you will independently lead event adjudication activities on large scale, high focus clinical trials and be a driving force in defining and setting up event adjudication for future trials.
Furthermore, you will be responsible for:
Guiding your colleagues in setting up the comprehensive processes for event adjudication
Oversee CRO performance, report on progress and ensure solid closure activities
Driving optimisation projects in the department and contribute to cross-functional improvement activities
Contribute to simplification and automation initiatives to navigate frequently changing legal requirements and guidelines
Setting direction for colleagues in a proactive and inspiring manner with focus on development and teamwork
Independent planning & prioritisation of tasks is a prerequisite to meet deliverables and timelines
This role will be also focused on facilitating strong collaboration between the event adjudication area and stakeholders in Medical, Data Management, Trial Management, Biostatistics, Affiliate colleagues and external CROs and KOLs.
Event adjudication 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 and simplification of this data landscape will be an integral part of your role.
Qualifications
To thrive in this role, you have:
A master’s degree, preferably within natural or health sciences, technical sciences or similar
Extensive experience with clinical trial conduct, GCP and project management
MS Office Skills
Worked with databases, reporting tools and you master new IT systems
Experience with event adjudication and working with CROs is an advantage
As a person you are proactive and like to work independently, as well as in a team. This includes having excellent collaborative skills and a high degree of flexibility, as well as high communication (with a proficiency in English), coordination and planning capacity. You are open-minded, dynamic, and eager to learn new processes and have a positive attitude to challenges.
About the department
The Event Adjudication area consists of three departments with a total of 27 highly engaged team members from various academic backgrounds. We establish and execute procedures for setting up, conducting, and closing event adjudication activities on clinical trials. We work in a fast-paced environment on an increasing number of trials, where clinical events are required to be adjudicated.
Event adjudication is a process where an external independent review board of medical specialists assesses relevant events for fulfilment of pre-defined clinical criteria. The process is driven out of the department in close collaboration with a wide range of internal stakeholders as well as external CROs.
Event Adjudication is part of Safety Operations, one of the functional areas in Global Safety and based in Søborg. We have an informal office culture where humour and good relations are valued as we believe it promotes collaboration, conversation, and teamwork, which is essential in our job. We offer an exciting job with lots of challenges among great colleagues in a positive working environment.
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 about the job please contact Department Manager Kirsten Bang Rungby (+45 3079 6242).
Deadline
09 August 2023. We encourage you to apply as soon as possible, as the applications will be reviewed on an ongoing basis.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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.
