Clinical Research Associate (m|f|d)

at  Miltenyi Biomedicine

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

• 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