Specialist Nonclinical Data Management - Munich, Deutschland - BI Pharma GmbH&Co

BI Pharma GmbH&Co

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

The Position:

As Specialist Data Management you generate dataset packages in accordance with the CDISC SDTM / SEND and FDA standards required for submission of nonclinical study data to the FDA.

Nonclinical Drug Safety at our Biberach site delivers high quality nonclinical safety data and expertise to drive patient safety and Boehringer Ingelheim's pipeline and business.

Tasks & responsibilities:

In new role, you will implement CDISC SEND processes in collaboration with scientists and technical staff of Nonclinical Drug Safety as well as IT coordinators, validation managers and system owners.
Moreover, you will act jointly with global internal and external partners to assure the high quality of datasets submitted to regulatory agencies by safeguarding that electronic datasets and nonclinical study reports match.
You will continuously scrutinize and improve current processes.
In addition, you will develop tools to facilitate e.g., data reporting and visualization.

Requirements:

Completed studies in e.g., Medical Documentation and Computer Science, Data Science in Medicine or a related field, or alternatively completed vocational training in sciences (e.g., BTA/CTA/MTA) with several years of professional experience
Experiences in data management and proficiency in the statistical software SAS
Knowledge of the CDISC SDTM/CDISC SEND standards, SQL, and of laboratory, information, and management systems highly preferred
Computer skills with MS Office
Highly reliable, independent, wellorganized team player with selfassured appearance
Good written and oral communication skills in German and English

Ready to contact us?:

Recruitment process:

Step 2:
Virtual meeting in the period from end of November

Step 3:
On-site interviews beginning of December