Beschreibung
We are searching a Clinical Data Manager for our client - a big pharmaceutical company in South Germany:The Data Manager is responsible for the coordination and supervision of the data management activities outsourced to external service providers, for the development and maintenance of internal CDISC standards for the clinical trials.
- Supervise and manage data management activities outsourced to service providers and provide guidance to them.
- Develop and maintain internal CDISC standards and supervise service providers ac-accordingly.
- Develop or review the user requirement specifications for EDC and other IT applications collaborating with cross functional groups.
- Determine the level of user acceptance testing (UAT) required for EDC and other IT applications and ensure that the UAT is performed to a satisfactory quality level.
- Writing and reviewing standard operating procedures (SOPs)
Your profile:
- At least 5 years of experience in a data manager role sup-porting clinical trials in the pharmaceutical industry
- Experience in CDISC standards
- Experience in setup of clinical databases and (e)CRF design
- Good understanding of global clinical trial practices, procedures and methodologies and ICH GCP guidelines.
- Good team player. Good business ethics
Location: officebased in Bavaria with one day homeoffice as option
Are you interested in this position? Just give me a call () or apply online.
Looking forward to hear or read from you.
Best,
Stefan
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