Clinical Data Manager | Clinical Data Manager (m,w,d)
Proclinical GmbH
Job Summary
As a Clinical Data Manager for a leading Life Sciences company in Frankfurt, you will play a pivotal role in defining and managing study-specific data procedures. Your daily responsibilities involve drafting data management and validation plans, coordinating the development and user testing of eCRF and eCOA systems, and overseeing electronic data transfers from external sources. You will ensure high data quality by monitoring medical coding (MedDRA/WHO-DD), reconciling safety data, and managing database locks. A key part of the role involves vendor management, where you will oversee CRO performance and participate in selection processes. This position is ideal for a professional who thrives in cross-functional environments and seeks to optimize data processes within a regulated framework. The role offers a secure working environment with a structured collective bargaining agreement and a thorough onboarding process, making it an excellent opportunity for those looking to advance their career in clinical research.
Required Skills
Education
Master's degree in Documentation, Medical Documentation, Medical Informatics, Bioinformatics, Natural Sciences, or a related field.
Experience
- Minimum of 3 years of professional experience in clinical data management
- Practical experience working with EDC systems and SAS software
- Proven experience in cross-functional collaboration and project management
- Experience in monitoring CRO performance and quality control measures
- Demonstrated knowledge of regulatory guidelines including ICH, GCP, and FDA
Languages
Additional
- This is a full-time, temporary position (Arbeitnehmerüberlassung) initially limited to 1 year. Candidates should provide their earliest possible start date.
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