Clinical Trial Assistant in Bergisch Gladbach bei Miltenyi Biomedicine

Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T cell therapies. We are bringing innovative treatments 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 technology whilst exploring treatments for other diseases. Our lead candidate, currently in pivotal stage clinical trials in Europe and the USA, is a tandem CAR T cell product.

You are working in the department Clinical Operations which is globally performing First-In-Man and Phase I-II Proof-of-Concept cell therapy clinical trials for our new assets. You support 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.
• 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.

• 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 comes naturally to you as well as being highly organized. Your are used to prioritize multiple tasks, to take initiative, to work independently and to achieve project timelines.
• 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.
• A sound knowledge of Microsoft Office and electronic clinical trial applications, e.g. CTMS or eTMF, is expected.

What we offer

• A modern workplace and 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 recognize yourself in the position described, please send us your application documents (cover letter, resume, references) online. Please state your salary expectations and earliest starting date.