Beschreibung
Key Skills:- The Data Manager is responsible for the coordination and supervision of the data management activities of the clinical trials outsourced to external service providers.
- Supervise and manage data management activities outsourced to service providers and provide guidance to them
- Ensure that Service Providers follow CDISC standards (SDTM/CDASH) and supervise them accordingly
- Mapping the datasets into SDTM with SAS software (including the generation of the SDTM specification)
- Generation of the Define.XML with SAS software
- Supervision of the implementation of eCRFs and IRT systems, including quality control and user acceptance testing
- Support quality control and quality checks of tables and listings
- Support the preparation of data for submission to the authorities as well as for pooled analyzes
- Develop or review the user requirement specifications for EDC and other IT applications collaborating with cross functional groups
- Support of data management SOP updates
Requirements:
- At least 5 years of experience in a data manager role supporting clinical trials in the pharmaceutical industry
- Intermediate to expert knowledge of / experience with EDC systems like OCRDC
- Experience in setup of clinical databases and (e)CRF design
- Experiences with other IT systems like IRT
- Profound knowledge in CDISC standards
- Ability to coordinate data management work across a clinical study
- Knowledge of / experience with SAS software
- Good understanding of global clinical trial practices, procedures and methodologies
- Good team player. Good business ethics
- Very good English (oral and written), German of advantage
Bitte senden Sie mir Ihren CV als Word-Datei per Email. Weitere Infos zur Stelle folgen telefonisch.
Ich freue mich auf Ihre Rückmeldung!
Herzliche Grüße aus München,
Carla Störzer