Principal Data Management Programmer

PRINCIPAL DATA MANAGEMENT PROGRAMMER (m/w)

Are you looking for your next exciting and challenging new position? Are you willing to enhance your abilities as Data Manager Programmer in an international environment?

Your benefits at one glance:

- TOP-Company with one of the best pipelines within the market
- attractive compensations
- Team spirit and ideal working atmosphere
- development possibilities
- interesting studies
- flexible working time

Your tasks:

- Setup of the clinical study database in close cooperation with the EDC database developer and data manager.
- Setup of Data Management tools for study conduct (e.g. edit checks, validity tool, coding call, SAE etc.).
- Full study programming and validation responsibility.
- Develop programs for transformation of the acquisition data from the EDC system \ data management system to the Operational Acquisition Database (OAD) to meet BSP project standards.
- Ensure in conjunction with (project) data manager adherence to BSP standards and validation of all study related calculations and data mappings.
- Full responsibility for data exchange with external parties, for example, CROs, external data providers (Labs, ECG, etc) and Data Monitoring Committees.
- Setup and support of medical review and reporting tools and listings used by customers in Data Management, Biostatistics, Global Drug Safety, Medical Affairs, Clinical Pharmacology, Regulatory Affairs and Study Management.
- Participate in global teams looking at continuous process improvement, including development \ enhancement of SOPs and OMs.

You should bring the following skills:

- Bachelor's degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation
- Experience with pharmaceutical industry
- Experience with ORACLE SQL LSH / Data repository / CDR
- Experience with SAS Programming
- Good understanding of the drug development process
- Good understanding of regulations, standards and guidelines (e.g. ICH, GxP, CDISC, European Clinical Trials Directive, Privacy rules [HIPPA])

Do you find this position interesting? Join our team and apply now!

Let's have a telephone conference and discover more about this job offer and the company. I look forward to speaking to you soon.

Valeria Gette
Consultant Clinical Data Management and Biostatistics
Tel.: 089 55 19 766