Clinical Research Associate (m|f|d)

51429 Bergisch Gladbach
Vollzeit
14.10.2024
Vollzeit
Miltenyi Biomedicine

Clinical Research Associate (m|f|d)

Stellenbeschreibung

Company Description


Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale.

Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.


Job Description


As a Clinical Research Associate, you will be responsible for overseeing Phase I and II clinical trials. This includes comprehensive site management, including selecting appropriate investigators, initiating and conducting routine monitoring on-site and remotely, and managing the close-out process. You will also play a key role in study planning and support the Clinical Trial Manager (CTM) by providing site specific documentation.

  • You will be responsible for ensuring compliance with the protocol, ICH/GCP, ISO14155, ethical and regulatory standards.
  • Your responsibilities will include conducting site monitoring visits - pre-study, study initiation, routine and study completion - and providing ongoing support to the sites, including remote monitoring.
  • You assist the operational team with the planning of clinical trials and act as a liaison between the trial centers and the operational team.
  • Another important aspect of your work is to support the operational team in maintaining the Trial Master File (TMF) at trial site level.
  • In addition, you will contribute to the implementation and improvement of detailed strategies for existing and new processes.

Qualifications
  • Having successfully completed a degree in natural sciences, you possess at least three years of experience in monitoring clinical trials.
  • Experience in oncology or cell therapy studies is beneficial.
  • You communicate confidently and appropriately in both German (C1) and English (B2).
  • Your strong self-organization, reliability, independent and proactive approach, perseverance, and diligence ensure that you confidently handle demanding tasks.
  • Your proficiency in MS Office completes your profile.

Additional Information


What we offer

  • Flexible and remote work: Enable time management on your terms
  • Diversity: International teams and cross-border intercultural communication
  • Room for creativity: It’s the most clever solution that we always strive for
  • Health & Sport: We offer a wide range of corporate sports activities and health provision
  • Miltenyi University: A clever mind never stops learning, take advantage of our inhouse Training Academy

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.