Description
DRA Clinical Trial Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Interact with internal departments or teams, affiliates and third parties as required to give regulatory input and guidance for clinical trials and their submission to European and international Health Authorities
- Prepare, submit and maintain CTAs to European and international HAs in accordance with the applicable regulatory requirements
- Interact with HAs and/or other parties regarding CTAs
- Ensure that timelines are met for submissions such as End of Trial notifications, Clinical Study Report synopsis, answers to HA questions
- Maintain the relevant sections of the Trial Master File for the duration of the clinical trial and prepare and QC the documentation before arranging final transfer
- Attend and contribute to CTT meetings, providing regulatory updates and information as required
- Keep the relevant CTT members informed of the status of HA-related matters, including forwarding copies of relevant documentation in a timely manner
Main qualifications
- A scientific background or working experience in Clinical Trials in Europe/Rest of World or in the
- Pharmaceutical industry would be an advantage
- Excellent spoken and written English
Main advantages:
- Pleasant working atmosphere
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
Referencenumber:
Make contact:
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