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 Senior Clinical Data Manager, you will play a key role in ensuring the quality, integrity, and compliance of clinical data across all phases of clinical trials. You will contribute to strategic process improvements, lead cross-functional initiatives, and support the development of internal and external data management teams:
1. You will develop and lead onboarding, training, and mentoring programs for internal and external Clinical Data Managers, ensuring consistent knowledge transfer and team growth.
2. Next to this, you will support the implementation and optimization of Veeva EDC and CDB platforms, contributing to data integrity and regulatory compliance across clinical trials.
3. As a result, you will ensure high-quality clinical data through rigorous review of protocols, CRFs, and statistical reports, enabling timely database locks and regulatory submissions.
4. As part of the team, you will drive cross-functional collaboration, coordinate with vendors, and contribute to KPI-based vendor management focused on performance and quality.
5. You will contribute to inspection readiness by integrating lessons learned into processes and supporting EMA submission activities with your broad clinical data expertise.
Qualifications
6. As an experienced Senior Clinical Data Manager, you hold a Master’s degree or higher in a science-related field and bring extensive hands-on expertise in managing clinical data across all phases of global trials in a pharmaceutical environment.
7. Your proficiency in clinical data systems and standards, including EDC, CTMS, MedDRA, CDISC, and Veeva Vault, supports high-quality data delivery and regulatory compliance.
8. You are naturally detail-oriented and highly organized, leading by example in SOP development, database validation, and collaboration with internal teams and external vendors.
9. You bring experience in cross-functional project management, working closely with clinical operations, biostatistics, and regulatory affairs to ensure inspection readiness and submission success.
10. With your strong communication skills and leadership mindset, you contribute confidently to FDA submissions and inspection processes, while fostering team development and continuous improvement.
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.