JOB OFFERINGS

We are hiring: 

Study Manager (f/m/d), full time position

 

Your education and experience:

  • University degree in natural science or medicine (MD or PhD) and sound knowledge in biochemistry, immunology, chemistry or biophysics
  • Expertise and several years of experience in one of the following areas is of advantage: Coagulation, Neuroscience, Companion Diagnostics
  • Practical experience in KOL management, e.g. discussion of study set-ups, organization of advisory boards
  • Ideally work experience in clinical study design, and execution of clinical studies including hands-on monitoring experience in the Diagnostics Industry
  • Knowledge of applicable standards and regulations for clinical trials and lab conduct would be helpful
  • Proven project planning / project management and organization skills
  • Demonstrated computer literacy (Word, Excel etc.) as well as proven statistical knowledge
  • Advanced oral and written communication skills (English and German) as well as interpersonal and leadership skills
  • Ability to analyze and solve problems and to make sound decisions
  • Independent way of work
  • Willingness to travel internationally and excellent intercultural awareness

Your tasks and responsibilities:

  • Overall Study design, while interfacing with Development, Life Cycle Teams, Clinical Development Teams, Clinical Science, Regulatory Affairs and Biostatistics
  • Planning of study content, study timelines and budgets as well as study execution and reporting
  • Ensuring the study conduct meets requirements for CE and FDA clearances/approvals
  • Assigning specific tasks to members of the Clinical Operations study team  and follow-up to ensure delivery
  • Study-specific training of CRAs / study team and keeping stakeholders updated on all relevant study activities and/ or changes
  • Oversight of Clinical Research Organizations, consultants and/ or medical advisors
  • Presentation of study results in workshops and in publications according to the requirements of the market
  • Compliance of all activities with applicable safety and quality management regulations as well as guidance documents

Are you interested?

Please send your application incl. CV, references and salary expectation to bewerbung@triga-s.de.

If you have further questions, please call 08847 / 695 78 117.