in Frankfurt | Employment with Hays Professional Solutions GmbH
Reference number
Start date
My duties
  • Submission to regulatory authorities and Independent Ethics Committee/Institutional Review Board (IEC/IRB)
  • Provision of trial-specific insurance
  • Provision of investigational product and trial-specific material
  • Support preparation of trial-specific templates for the study conduct
  • Support administration of Confidential Disclosure Agreements and Clinical Trial Agreements including legal
  • Support document management via eTMF service provider
  • Support preparation of TMFs/eTMFs for long-term archiving (paper archive, E-Archive, BFlow, as applicable)
  • Support redaction of documents for publication purposes (e.g., EU CTReg CTIS)
  • Support coordination of internal and external operational tasks
  • Ensure compliance with internal SOPs and relevant regulatory requirements
  • Support audits and management of CAPAs in collaboration with involved functions
  • Organization of internal/external meetings (scheduling, agenda, invitations, documents, equipment, minutes, etc.)
  • Support maintenance of trial database (e.g., METIS)
My qualifications
  • University degree in life sciences or medical health (Bachelor) or other professional qualifications equivalent to university degree
  • Experiences in coordinating and conducting of administrative clinical trials tasks
  • Experiences in clinical study processes
  • Knowledge in clinical research and in the conduct of clinical trials
  • Knowledge in relevant regulations (ICH GCP, EU CTR, etc.)
  • Adequate verbal and written communication skills
  • Basic knowledge of medical or scientific terminology
  • Fluent (business) English
  • Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications
  • Flexibility and ability to support various clinical trials and teams in parallel
  • Team-oriented working style
My benefits
  • Working in an international company
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in 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 experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
My contact at Hays

My contact person
Charlene Wunsch

Reference number

E-Mail: charlene.wunsch@hays.de