- Leading and guiding the CDC project team, including Clinical Research Associates, Clinical Trial Administrators and other involved roles (eg Start-Up, Contract, Medical Monitor) for multiple projects. Providing operational and therapeutic expertise to the CDC project team to ensure deliverables (including recruitment) are met within the agreed timelines and in accordance with scientific, quality, and regulatory requirements.
- Ensuring effective communication of all project related issues between Headquarters, CDC, the region, and other Internal/external stakeholders.
- Being responsible for representing the Netherlands in relevant study meetings and/or organizing these meetings. For example, Monitor meetings, Investigator meetings and Study Result meetings.
- Driving assigned clinical projects from Feasibility to Clinical trial reporting. Overseeing all local activities including local budget preparation, clinical trial agreements, planning, site selection, site initiation, Ethics Committee and Health Authority submissions, data quality, and organizing investigator meetings.
- Master's level education in Life Sciences. Professional proficiency in English and Dutch
- ≥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.
- 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.
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Trial Manager- Clinical Development Centre Netherlands - Alphen aan den Rijn, Nederland - Novo Nordisk A/S
Beschrijving
Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Join our 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:
Qualifications
To be successful in this role, we expect you to have the following qualifications:
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 a Clinical Trial Administrator, reporting directly to the Therapy Area Head.
