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

External
Da Vinci Engineering GmbH logoDa Vinci Engineering · Frankfurt Am Main, Germany
Full-timeUnknown1w ago
ComplianceCross-functional CollaborationDocumentationGCPMedical CodingSAS
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About the role

Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us! (Senior) Clinical Data Manager (m/f/d) Stellen-ID: 22270 Standort: Frankfurt am Main 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 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 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 Kontaktdaten für Stellenanzeige Frau Andrea Cindric Da Vinci Engineering GmbH Hauptstätter Straße 149 70178 Stuttgart +49 711 72240 107 job@davinci.de


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