As a senior Clinical Clinical Research Associate/Clinical Trial Manager based in The Netherlands, you independently work on more complex clinical research projects according to Siron Clinical and/or Sponsor Standard Operating Procedures, ICH-GCP, FDA and other applicable guidelines.
You are responsible for conduct of feasibility, pre-study and initiation visits, all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, liaise with vendors and for all aspects of site management as prescribed in the project plans.
In addition other duties can be assigned.
Qualifications and experience
- University or HBO degree, preferably in science or health-related discipline;
- Minimum of 5-10 years experience in monitoring and conducting clinical research within GCP/ICH and local guidelines, laws and requirements;
- Extensive knowledge of all applicable regulations and guidelines;
- Ethics Committee and Competent Authority submissions and experience in site contract negotiations;
- Excellent written and verbal communication skills;
- Strong organizational, time management, and problem-solving skills and the ability to work independently;
- Strong interpersonal skills, able to work within a multicultural environment and assertively deal with difficult situations;
- Proven ability to manage multiple activities, meet timelines and set priorities;
- Fluent in Dutch and English, spoken and written;
- Strong knowledge of computers and standard computer applications;
- Flexibility and ability to travel routinely as required by the study.
If this position sounds like the next step in your career, please send us your CV and a motivational cover letter via email to: firstname.lastname@example.org