Clinical Data Manager
Summary :
Our client seeks a Clinical Data Manager to join their Clinical Operations Department, supporting either home-based or office-based work in Germany.
The ideal candidate will possess strong analytical skills, an action-oriented approach, and excellent organization and communication abilities.
Responsibilities :
- Supervise and manage data management activities, providing support to clinical trial team members.
- Oversee the development, implementation, and change management of clinical data management activities and systems.
- Ensure compliance with CDISC standards and participate in defining and implementing eCRF / IRT standards.
- Review clinical trial documents and develop and maintain SOPs, guidance documents, and training materials.
- Archive clinical trial databases and related documents.
Requirements :
- Advanced degree in Life Sciences or Computer Sciences, or equivalent experience.
- Minimum 5 years of data management experience in the pharmaceutical / biotechnology industry.
- Database programming knowledge is a huge plus
- Proficiency with EDC and IRT systems, CDISC (SDTM) expertise, and experience in data management project management.
- Expertise in SAS programming / R programming and knowledge of medical terminology, coding, and SAE reconciliation preferred.
- Thorough understanding of ICH-GCP, FDA, and EMA regulations.
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