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(senior) clinical data manager (m/f/d)

Frankfurt am Main
Da Vinci Engineering GmbH
Manager
Inserat online seit: 4 Mai
Beschreibung

(Senior) Clinical Data Manager (m/f/d)

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


Your profile

* 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 ISOis 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


You can expect ..

* 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!

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