About this role
Werfen is a family-owned leader in specialized diagnostics including Hemostasis, Acute Care, Transfusion, Autoimmunity, and Transplant. The Clinical Data Manager designs, manages, and oversees quality of clinical study data for performance studies. This ensures compliance with GCP, 21 CFR Part 11, IVDR, and internal systems.
Daily tasks involve developing Data Management Plans, data workflows, and specifications for transfers from labs or LIMS. Oversee data entry, cleaning, query management, and reconciliation across sites and labs. Identify discrepancies and ensure protocol compliance in data collection.
Collaborate with Clinical Research Associates, R&D, Regulatory, and Biostatisticians for data integration and analysis-ready datasets. Manage complex lab data like method comparisons and reproducibility studies. Work cross-functionally to prepare for audits and submissions.
Lead database lock, provide cleaned datasets for 510K and IVDR regulatory filings. Maintain audit-ready documentation in the Quality Management System. Join a passionate team dedicated to innovation, quality, and improving patient care through hospital efficiency.
Requirements
- Experience in clinical data management for performance studies in diagnostics
- Knowledge of GCP (ICH E6 R3), 21 CFR Part 11, and IVDR requirements
- Familiarity with FDA IVD guidance and EU IVDR Annexes II–XIII
- Proficiency in data reconciliation, query management, and database lock processes
- Ability to handle data from central labs, R&D assay systems, or LIMS
- Experience generating analysis-ready datasets with Biostatisticians
- Understanding of CLSI standards and guidelines for clinical data
Responsibilities
- Develop and maintain the Data Management Plan (DMP), data workflows, and data handling procedures
- Collaborate during protocol development to ensure data requirements are fully defined
- Oversee clinical data entry, data review, and query management
- Monitor site and lab data for accuracy, completeness, and protocol compliance
- Perform routine data reconciliation and identify trends or discrepancies
- Manage data imports and validation for complex laboratory datasets
- Lead database lock activities and provide final cleaned datasets for regulatory submissions
- Ensure compliance with GCP, 21 CFR Part 11, IVDR, and CLSI standards
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