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 an Associate Clinical Trial Manager, you will support the Clinical Trial Manager in ensuring the successful planning, execution, and oversight of clinical trials at the country level. Your contribution will be essential to maintaining high-quality standards and meeting project timelines.
1. Act as the primary point of contact for specific assigned clinical trial sites, coordinating all activities from start-up to close-out, including CRO oversight.
2. Support the development and implementation of operational plans, site trainings, and study materials to ensure protocol compliance and enrolment success.
3. Monitor study progress, contribute to enrolment strategies, and escalate issues or delays to the Clinical Trial Manager or Group Leader as needed.
4. Review and manage essential documents (e.g. protocols, informed consent forms), support Trial Master File (TMF) maintenance, and ensure GCP and SOP compliance.
5. Collaborate with cross-functional teams (e.g. regulatory affairs, medical affairs, quality assurance, logistics, manufacturing, and many more) and contribute to process improvements, including the creation and revision of SOPs and templates.
Qualifications
6. We are looking for a proactive and communicative team player with a strong interest in clinical research and operational excellence. You thrive in a dynamic environment and bring a structured, solution-oriented mindset.
7. Academic background in life sciences, natural sciences, medicine, or a related field and proven experience in clinical research or clinical trial coordination, ideally with exposure to Medical Affairs, Clinical Operations, or related functions.
8. Strong organizational and communication skills, with the ability to manage multiple priorities and collaborate across teams.
9. Fluent in English and German; every other European language like French, Spanish, etc is a plus. Confident in using MS Office and clinical trial systems (e.g. CTMS, eTMF).
10. Willingness to travel and engage with clinical sites and stakeholders; previous experience in hemato-oncology, or cell therapies is highly valued.
Additional Information
What we offer
11. Working with free and self-determined time management, also mobile working
12. An intercultural environment characterized by diversity and flat hierarchies
13. Freedom to contribute creatively and play an active role in shaping the company
14. Individual further training in our Miltenyi University as the core of the Miltenyi DNA
15. days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more.
Diversity is the bedrock of our creativity
Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots – across various disciplines, linking different perspectives, skills, and abilities.
You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability.
Become part of our team and focus on pushing the borders of medicine.
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.