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Clinical Trial Assistant

vor 4 Monaten


Bergisch Gladbach, Deutschland Miltenyi Biomedicine Vollzeit
Job Description

As a Clinical Trial Assistant, you will be supporting the Clinical Trial Manager in all aspects that are required to keep the quality and timeliness of study data and communication on a high level:

  • You support the distribution and tracking of critical clinical documents and information, e.g. essential documents, study supplies, budgets, manuals, other site and subject related information and investigational product releases in collaboration with the study team.
  • Next this, you support the preparation and submission of study documents to IRB/IEC and regulatory authorities and assist in the collection or creation and maintenance of study startup documents, such as training materials, logs and informed consent.
  • You coordinate the filing and reconciliation of Trial Master File documents.
  • In addition, you support the study team by proactively identifying, resolving, and/or escalating issues to assigned staff.
  • Lastly, you assist with the creation and distribution of study-level communication to stakeholders and participate in internal team meetings, taking minutes and providing status updates.

 


Qualifications

  • You have already gained experience in clinical research as a clinical trial associate, clinical research associate and/or clinical study coordinator in the pharmaceutical/biotech industry.
  • Attention to detail and high organization come naturally to you. You are accustomed to prioritizing multiple tasks, taking initiative, working independently, and achieving project deadlines.
  • As a motivated and open-minded team player with well-developed interpersonal abilities, you enjoy working in a dynamic environment. You are naturally communicative and have effective communication (verbal and written) and organization skills, both in English and German.
  • Ideally, you have already experience with hematological and/or oncological clinical studies and you are interested in cellular therapies.
  • Your proficiency in MS Office and electronic clinical trial data management systems, e.g. CTMS or eTMF, is also expected.


Additional Information

What we offer

  • A modern workplace in Bergisch Gladbach with opportunity for some mobile work. Exciting opportunities in the development of technologies with a secure future. 
  • Cross-border intercultural cooperation and short communication channels 
  • A collegial corporate culture and flexible working hours enable time management on your own terms 
  • Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University 
  • Diverse corporate benefits with regard to employee health, sport, and staff events

We look forward to your application

If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.