We have an exciting new opportunity for a clinical trial administrator (CTA) within a large pharmaceutical concern in Leiden!
For one of our clients within pharmaceutical industry we are looking for a CTA specialist with expertise in the field of clinical trials and studies. In this teamy ou are responsible for the distribution and submission of data and documents for all required registries. This includes direct submissions, but can also involve close collaboration with local country teams.
As a team you ensure accurate, validated and consistent clinical trial data which is posted on clinical trial registries worldwide in compliance with laws and regulations.
- Responsible for the distribution and submission of data and documents for all required registries .
- Act as an subject matter expert on clinical trial disclosure requirements
- Advise company teams with regards to registry-related questions
- Responsible for obtaining disclosure ready data and documents from business partners in various departments and external service providers
- Ensure that disclosure data and documents meet quality requirements.
- Maintain and report disclosure planning in the compliance management system and ensure it is aligned with other planning, such as in clinical trial operations and medical writing
- You maintain and coordinate with other functions changes in the disclosure planning and independently resolve items that put the disclosure planning at risk
- BSc or MSc in analytical science or equivalent;
- A minimum of 3 years of work experience is required, preferably in the pharmaceutical or biotechnology industry (starters do not qualify);
- Awareness of disclosure legislation is a plus.
- A team player, pro-active and result-oriented;
- English is a Must, Dutch is considered a plus;
- Located in the vicinity of Leiden;
- Valid Dutch work permit is a must, candidates not in possession of a work permit will not receive a response;
- Contract: 1 year via Oxford, realistic long- term perspective;
- Salary: €4000- €4800 gross monthly based on a full-time position;
- Holidays: 25;
- Working hours: full-time, 32 hours possible; remote work is possible for 2 days a week
- Region: Leiden;
- Vacancy number: 20903;