Description
We are looking for a
Clinical Data Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM+
Ort: in Baden-Württemberg
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- 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
Ihre Qualifikation
- 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
Skills:
- Clinical data manager