Senior Clinical Data Manager

Senior Clinical Data Manager

Miltenyi Biotec

Bergisch Gladbach, Germany

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:

• You will develop and lead onboarding, training, and mentoring programs for internal and external Clinical Data Managers, ensuring consistent knowledge transfer and team growth;
• 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;
• 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;
• 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;
• You will contribute to inspection readiness by integrating lessons learned into processes and supporting EMA submission activities with your broad clinical data expertise.

Qualifications

• 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;
• Your proficiency in clinical data systems and standards, including EDC, CTMS, MedDRA, CDISC, and Veeva Vault, supports high-quality data delivery and regulatory compliance;
• You are naturally detail-oriented and highly organized, leading by example in SOP development, database validation, and collaboration with internal teams and external vendors;
• You bring experience in cross-functional project management, working closely with clinical operations, biostatistics, and regulatory affairs to ensure inspection readiness and submission success;
• With your strong communication skills and leadership mindset, you contribute confidently to FDA submissions and inspection processes, while fostering team development and continuous improvement.