Senior Clinical Data Manager (m|f|d)

About the Company

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.

• Develop and lead onboarding, training, and mentoring programs for internal and external Clinical Data Managers, ensuring consistent knowledge transfer and team growth.
• Support the implementation and optimization of Veeva EDC and CDB platforms, contributing to data integrity and regulatory compliance across clinical trials.
• Ensure high‑quality clinical data through rigorous review of protocols, CRFs, and statistical reports, enabling timely database locks and regulatory submissions.
• Drive cross‑functional collaboration, coordinate with vendors, and contribute to KPI‑based vendor management focused on performance and quality.
• Contribute to inspection readiness by integrating lessons learned into processes and supporting EMA submission activities with your broad clinical data expertise.

Qualifications

• Master’s degree or higher in a science‑related field and extensive hands‑on expertise in managing clinical data across all phases of global trials in a pharmaceutical environment.
• Proficiency in clinical data systems and standards, including EDC, CTMS, MedDRA, CDISC, and Veeva Vault, supporting high‑quality data delivery and regulatory compliance.
• Detail‑oriented, highly organized, leading by example in SOP development, database validation, and collaboration with internal teams and external vendors.
• Experience in cross‑functional project management, working closely with clinical operations, biostatistics, and regulatory affairs to ensure inspection readiness and submission success.
• Strong communication skills and leadership mindset, contributing confidently to FDA submissions and inspection processes while fostering team development and continuous improvement.

What We Offer

• Free and self‑determined time management, including mobile working.
• An intercultural environment characterized by diversity and flat hierarchies.
• Freedom to contribute creatively and play an active role in shaping the company.
• Individual further training in our Miltenyi University as the core of the Miltenyi DNA.
• 30 days vacation, discounted ticket to Germany, e‑bike leasing, capital‑forming benefits, company pension plan, disability insurance, canteen, and much more.

Diversity and Inclusion

Diversity is the bedrock of our creativity. Our mission is to innovate treatments and technologies and tackle the world’s most serious health challenges. We connect the dots across various disciplines, linking different perspectives, skills, and abilities. You are welcome in our inclusive and collaborative environment, regardless of gender, sexual identity, age, ethnicity, religion, or disability.

Contact Information

Internal application deadline:

Internal contacts:

• Abidé Papaki‑Gbadoe (HR):
• Sebastian Müller (Line Manager; Clinical Data Management): ‑6647

Internal job title: Senior Data Manager

Seniority level

Associate

Employment type

Full‑time

Job function

Other

Industries

Pharmaceutical Manufacturing

Location

Bergisch Gladbach, North Rhine‑Westphalia, Germany

Apply

We look forward to your application. If you want to work in an open, creative and supportive team, we look forward to receiving your application along with your salary expectations and availability.

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