DRA Clinical Trial Manager (m/f/d)

☞ mamgo

View: 183

Update day: 21-03-2024

Location: Allschwil Basel-Landschaft BL

Category: R & D IT - Software

Industry: Internet Publishing

Position: Associate

Job type: Full-time

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Job content

My duties
  • Preparing, submitting and maintaining CTAs to European and international Health Authorities (HAs) in accordance with the applicable regulatory requirements
  • Ensuring proper running of designated trials during their life cycle from a regulatory perspective, including tracking and maintenance of relevant documentation
  • Interacting with internal departments or teams and third parties (e.g., External Service Providers [ESPs]) as required to give regulatory input and guidance for clinical trials and their submission to European and international HAs
  • Acting as a regulatory representative on the Clinical Trial Team; providing the CTT with input on HA CTA submission and maintenance processes, as well as providing regulatory updates and other information as required

My Qualifications
  • Previous experience in preparing, submitting and maintaining Clinical Trial Applications to European and International Health Authorities in accordance with the applicable regulatory requirements
  • Thorough understanding of the regulatory requirements applicable for submission and maintenance of CTAs in and outside of Europe (e.g., Clinical Trial Directive, Clinical Trials Regulation, etc.)
  • Excellent organizational, interpersonal, and communications skills, together with meticulous attention to detail
  • Ability to work efficiently and effectively to tight deadlines
  • Ability to work both independently and as part of a team
  • Excellent spoken and written English (knowledge of another European language would be an advantage)

My Benefits
  • A highly motivated team and an open way of communication
  • Interesting tasks in a multinational environment
  • Modern, perfectly equipped workplace

About Hays

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

Contact

E-Mail: positionen@hays.ch

Tel: +41 44 225 50 00

Reference number

593524/1
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Deadline: 05-05-2024

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