DRA Clinical Trial Manager (m/f)

Beschreibung

• 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

• 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