Head of Clinical Operations – full time

 

Your responsibilities:

  • Representing the clinical research department
  • Management of all operational clinical activities, internally and externally
  • Generating clinical development plans and setting up clinical studies
  • Preparation and submission of documents to regulatory authorities
  • Coordination and supervision of contract research organisations, third party vendors and investigational sites
  • Milestone monitoring of clinical trial progress
  • Drafting and revising of study documents and reports in cooperation with contract research organisations, investigational sites and scientific consultants
  • Development and revision of regulatory documents and coordination of their timely submission to authorities and ethic committees
  • Initiating and regular updating of Standard Operating Procedures
  • Coordinating the preparation of Case Report Forms
  • Organisation of and attendance at investigator meetings
  • Mentoring and training of investigational sites and contract research organisations as well as new employees involved in clinical trial management
  • Timely delivery of defined results
  • Frequent reporting to C-level

Your profile:

  • Scientific, pharmaceutical or medical degree
  • Several years of clinical research experience throughout the different phases of clinical development
  • Profound experience with the setup, conduct and management of clinical studies
  • Detailed knowledge of ICH- and GCP-guidelines
  • Familiar with national and international laws and guidelines
  • Dealing with different indications, evaluations and reporting activities and obligations
  • Up-to-date knowledge of FDA and EMA regulations and guidelines preferable
  • Fluent in spoken and written English and German
  • Hands-on approach
  • A committed team player who is able to cope with pressure
  • Willingness to travel (20-30%)

We offer:

  • To be part of a successful and growing company
  • Exciting projects and international activities
  • Self-Responsible and autonomous work environment
  • Flexible working hours

If you enjoy working in a dynamic, motivated and international team with an open and friendly corporate culture we are looking forward receiving your application (incl. CV and photo).

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