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 Trial Assistant (CTA) in the Quality & Compliance (QC) area, you play a key role in supporting the integrity and regulatory alignment of clinical trial documentation and processes. This role works closely with quality specialists to ensure that trials meet internal standards and external requirements.
1. You update and maintain the trial documentation tools that track compliance, ensuring they are accurate, up to date and readily available to all stakeholders.
2. You assist the CTQC Specialist in tracking and overseeing the completion of Corrective and Preventive Actions (CAPAs) across assigned studies.
3. As a valuable member of the CTQC team, you support in the preparation of and support during internal audits and regulatory inspections, helping ensure smooth processes.
4. Next to this, you contribute to the maintenance of the Trial Master File (TMF), including document filing and organization, and collaborate with CTQC TMF Specialists to uphold TMF quality standards.
5. Also, you actively participate in process improvement initiatives and support the revision and implementation of Standard Operating Procedures (SOPs) to enhance trial efficiency and compliance.
Qualifications
6. You hold a university degree in Life Sciences, Natural Sciences, or a related healthcare field and/or bring hands-on experience in clinical research, ideally as a Clinical Trial Associate, Clinical Research Associate, or Clinical Study Coordinator within the pharmaceutical or biotech industry.
7. Attention to detail comes naturally to you as well as being highly organized. You are used to prioritize multiple tasks, to take initiative, to work independently and to achieve project timelines.
8. 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. German is a plus.
9. Your proficiency in MS Office and electronic clinical trial data management systems, e.g. CTMS or eTMF, is expected with an affinity for digital tools and dashboards.
10. Finally, you have a high attention to detail, solution-oriented and proactive mindset.
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.