Head of Clinical Operation and Training (m/f/d)

Bayern | Permanent employment with our customer
Reference number
My duties
  • Ensure GCP compliance for clinical studies
  • Maintain QMS, elaborate necessary SOPs and manuals
  • Conduct qualification audits of vendors completing clinical functions worldwide to ensure compliance with Good Clinical Practice (GCP) regulations, and the International Conference on Harmonization (ICH)
  • Participate in oversight of vendors completing clinical functions.
  • Perform audits of clinical investigator sites. Ensure complete and adequate follow-up is completed.
  • Participate as a QA member of project team for clinical studies
  • Assist Management in oversight of vendors and consultants conducting clinical investigator site audits
  • Maintain a current working knowledge of the US and EU GCP requirements, ICH Guidelines, industry practices, internal policies and procedures that impact regulatory compliance
  • Participate in the development and implementation, of standard operating procedures for Clinical Quality Assurance activities
  • Provide training as required
  • National and international travel as needed
My qualifications
  • Academic scientific degree
  • Professional experience Pharmaceutical Company or CRO
  • Knowledge and understanding of the GCP rquirements
  • Ability to communicate clearly and effectively
  • Capability to manage multiple priorities in an efficient manner; well organized, able to work in an international team environment
  • Business-fluent in English
My benefits
  • International Company
  • Homebased option
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

My contact person
Ulrike Basedow

Reference number

E-Mail: ulrike.basedow@hays.de