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(Senior) Clinical Data Manager (m/f/d)
- Hessen, Saxony-Anhalt, Germany
- Hessen, Saxony-Anhalt, Germany
À propos
Wir suchen kluge und innovative Mitarbeiter:innen, die etwas bewegen wollen. Wenn Sie gerne in einem dynamischen Team mit flachen Hierarchien arbeiten wollen, freuen wir uns auf Sie!
Your tasks:- Define trial-specific data management procedures, including the Data Management Plan and Data Validation Plan.
- Coordinate development, administration, updates, and UAT of eCRF and eDiary/eCOA systems, including user management
- Organize and specify electronic data transfers from external data sources
- Define and manage regular data management status reports, including content and distribution
- Oversee medical coding activities (MedDRA, WHO-DD) and ensure accurate safety data reconciliation
- Coordinate database freeze and lock activities, ensuring timelines and data quality standards are met
- Drive process optimization and oversee CRO performance, ensuring compliance, quality, and cross-functional collaboration
- Master’s degree in a relevant field (e.g., Medical Documentation, Informatics, Bioinformatics, Natural Sciences) with 3+ years of clinical data management experience
- Proficiency in Microsoft Office, EDC systems, and SAS; knowledge of CDISC and ISO 14155 is a plus
- Strong understanding of ICH, GCP, and FDA guidelines and their practical application
- Analytical, structured, and solution-oriented working style with strong organizational and project management skills
- High resilience, emotional intelligence, and ability to adapt quickly to changing priorities
- Strong team player with cross-functional collaboration skills and ability to influence others
- Fluent in English with excellent written, verbal, and interpersonal communication skills
- Experience in exciting and international projects
- Continuous salary development
- Da Vinci Corporate Benefits
- On-the-job training and language courses
- Appreciation, motivation and commitment
Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!
Compétences linguistiques
- English
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