DRA Clinical Trial Manager (50%) (m/f)

REFERENZNUMMER:

342710/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager