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Clinical Data Manager (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Projektbeschreibung

- Managing data management projects of external providers and monitoring project activities (responsible for deadlines, budget, regulatory requirements)
- Maintaining a good relationship with CROs
- Reference person for clinical studies (for other departments such as Clinical Research, Clinical Programming, Regulatory Management etc.)
- Coordination training for the study team
- Collecting and monitoring study data/metrics
- Taking part in investigators' meetings and giving input as needed
- Collecting, reviewing and archiving the data management plan and other documents for the studies
- Supervising and executing user acceptance testing on systems of clinical data management
- Ability to give input into changing data management as needed (e.g. clinical trials methodology)
- Validating electronic data streams and systems
- Extended experience in computerized data management in a pharmaceutical or clinical research setting
- Understanding of the drug development process, clinical trial methodology and data management principles are required
- Very good communication skills
- Knowledge of SAS and database programming
- Understanding of CDASH and CDISC standards
- Following regulation need to be familiar: FDA, international regulations, GCP

Weitere Qualifikationen: Clinical data manager

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland