Description
We are looking for a
DRA Clinical Trial Manager (50%) (m/f)
Reference: -en
Start: asap
Duration: 9 MM+
Place: in Basel-Country
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Interact with internal departments, teams and third parties to give regulatory input and guidance for clinical trials and their submission to European and international health authorities
- Prepare, submit and maintain Clinical Trial Applications (CTA) to health authorities in accordance with the applicable regulatory requirements
- Request and collect appropriate documents to arrange submissions
- Ensure proper running of the trial and interact with health authorities
- Ensure that the timelines are met for submissions and track sheets listing submissions and approval dates for CTAs, amendments and submissions
- Maintain the relevant sections of the Trial Master File and prepare and review the documentation before arranging the transfer
- Provide advice to the clinical trial members and keep them informed about the status of health authorities matters
Your qualifications
- A scientific background or working experience in Clinical Trials in Europe or rest of the world in the pharmaceutical industry
- Good organisational and communication skills
- Ability to prioritise tasks and work to deadlines
- Excellent spoken and written in English - every other language would be of advantage
Skills:
- Regulatory affairs manager