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CDC Trial Manager

Novo Nordisk

Novo Nordisk

Alphen aan den Rijn, Netherlands
Posted 6+ months ago

Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Come be part of our cardiovascular team as we embark on an exciting journey of growth! Make a real impact with us, as a Clinical Trial Manager at our recently established Clinical Development Centre (CDC) in the Netherlands.

This is a hybrid role and you should be able to go to the office from time to time.

The Position

As a key member of our Clinical Development team, you will play a crucial role in overseeing the project management of clinical trials within the country. As a Clinical Trial Manager, you will be responsible for making sure that deliverables are met as per project timelines, within budget and complying with protocol, country regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and Novo Nordisk SOPs (Standard Operating Procedures).

Key responsibilities include:

· Leading and guiding the CDC project team, including Clinical Research Associates and Clinical Trial Administrators, start-up teams about the protocol and other protocol related information, providing operational and therapeutic expertise to the CDC project team, achieve deliverables (including recruitments) within agreed timelines and in accordance with scientific, quality, and regulatory requirements.

· Ensuring effective communication of all trial/project related issues between Headquarters, CDC, the region, and other Internal/external stakeholders.

· Being Responsible for representing country in relevant study meetings and organizing these meetingsTrial Squad Meetings Monitor meetings, Investigator meetings and Study Result meetings.

· Driving assigned clinical trials from the feasibility to Clinical trial reporting. Overseeing as a project manager activities including planning, site selection, Ethics committee and health authority submissions, starting-up trial sites and organizing investigator meetings.

Qualifications

To be successful in this role, we expect you to have the following qualifications:

· Master's level education in Life Sciences.

· ≥5 years of previous experience in the healthcare industry, including trial management and monitoring according to ICH-GCP methodology.

· Successful track record in project managing clinical trials. Experience in the cardiovascular therapy area is a plus.

· Strong knowledge of clinical trial methodology, drug development process, and up-to-date understanding of ICH GCP and regulatory issues.

· Desirable experience in more than one phase of development and international trial coordination.

· Professional proficiency in English and Dutch

You should also be a team player and a responsible person.

The Department

Our Clinical Development Centers, part of the Clinical, Medical and Regulatory Departments, are the backbone in clinical trials and have the benefits of strengthened partnerships and launches. We conduct clinical trials in more than 50 countries around the world, in close collaboration with our affiliates, regions and global teams.

You will be a part of our large, resourceful development team that plays a crucial role in the ambitious drug development programs at Novo Nordisk. Our highly motivated team is composed of over 40 employees, and you will become a part of a team of multiple Clinical research associates and an administrator, reporting directly to the Cardiovascular Therapy Area Head.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

Please submit your application via the Novo Nordisk website.

Deadline

Apply before 20 December 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.