Event Adjudication Professional (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Are you motivated by the opportunity to drive collaboration with Clinical Research Organisations (CROs)? Would you like to understand stakeholder needs and collaborate across the organization? Do you want to join a diverse and high performing international team in a fast-growing company?

If yes, this is your opportunity to join a fantastic team in a fast-developing area, where you will gain a unique understanding of the key processes involved in our clinical trials.

We are looking for an Event Adjudication Professional to work in Søborg, Denmark. Apply now for a life-changing career!

The position

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 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.

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 is an integral part of all roles in our area.

As an Event Adjudication Professional, you will use project manager capabilities to drive event adjudication activities in assigned clinical trials.

Your main responsibilities will include:

• Driving collaboration among stakeholders, including Medical & Science, Data Management, Trial Management, Biostatistics, Affiliate colleagues, and external CROs

• Contributing to the set-up of comprehensive processes for event adjudication, ensuring efficient and accurate handling of clinical trial data

• Overseeing the performance of external CROs involved in event adjudication, ensuring adherence to quality standards and timelines, while working with compliance and quality to ensure audit and 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, you will get the chance to contribute to optimization activities within the department and participate in cross-functional improvement and innovation projects.

Qualifications
To thrive in this role, you ideally have:

• Master’s degree, preferably within natural or health sciences, technical sciences, engineering or similar

• Knowledge of clinical trial conduct and Good Clinical Practice (GCP)

• Flair for project management

• Experience in working with databases and reporting tools, and ability to quickly acquaint with and master new IT systems

• Strong proficiency in English combined with strong MS Office skills, specifically with Excel

• Experience in working with CROs is an advantage

As a person you are proactive, open-minded, dynamic, and eager to learn. You have a quality mind-set, excellent collaborative skills and a positive attitude towards changes and challenges. You can work both independently and in a team. Furthermore, it is expected from you to have a high degree of flexibility, and a keen interest in coordination and planning.

About the department

The Event Adjudication (EA) area consists of three departments with a total of 32 highly engaged team members from various academic backgrounds. We are part of Global Safety Operations, one of the functional areas in Global Safety. Two of the EA 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.

Contact

For further information, please contact Trine Allerslev, Senior Manager at [email protected]

Deadline

3 November 2024

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 CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

Applications will be evaluated continuously when received.

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.