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

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

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• Experience in exciting and international projects.
• Continuous salary development.
• On‑the‑job training and language courses.
• Appreciation, motivation and commitment.