Working as a Expert Business Technology Manager in DS3 focus area Compliance, Standards & Medical Coding.

Recent focus has been on streamlining and optimizing the clinical operations system landscape. To support the initiative, our key business capabilities related to clinical operations are consolidated on one core platform: Gemstone. Gemstone is a Software as a Service provided by Veeva and contains modules of their Vault Clinical suite. Where possible the system remains as close to "out of the box" as possible to align with industry standards and to reduce the complexity for the 3 general releases provided by Veeva. eTMF, Startup, Monitoring, Site Connect, Feasibility components are already live. The latest Gemstone „Ruby“ went live over Eastern (April 23). IRIS is now retired, and Issue Management, Monitoring, and Study Risk Management and Study Training are available in Gemstone with more capabilities to come. Gemstone interfaces with over 50 systems and is closely integrated with RAVE, RAVEN, BRAVE and other systems. Gemstone provides a modern technology foundation with API capability, allowing connection via the Integration Hub, a bespoke PaaS solution with a unified data integration layer. As not all systems are as advanced, the Integration Hub provides a database facade that allows backward compatibility to cater to those legacy systems.

Team R&D Master Data Management (MDM) is responsible for the processes and technologies used to ensure the consistency, accuracy, and completeness of critical data that is used across various departments and functions within the R&D organization. MDM plays a crucial role in ensuring the reliability of scientific and clinical data used for research, drug development, regulatory submissions, and decision-making. Key responsibilities include: define and implement data standards & policies, develop and maintain a centralized master data repository, establish data quality controls, ensure data steward- and ownership, manage data integration from different sources and systems, ensure compliance with regulatory requirements and provide training and support for end-users across R&D to ensure proper use and interpretation of data.

Scientific work in Pharma R&D requires a reliable high-quality body of data and knowledge. Bayer Pharma R&D has an extremely large amount of scientific data. The use of a Data Catalog significantly improves the findability of data and serves as a key pillar in the implementation of a comprehensive data strategy.

Collaborations with external partners may lead to joint legal rights for compounds and data, which may restrict reusage in other projects. With the increasing number of collaborations at Bayer and with advancing time, memories of the project details fade, and reconstruction of the status will be nearly impossible. Therefore, we aim for a system to document the role of compounds, which will facilitate decisions on further usage in other collaborations. For more information contact: Miriam Wollenhaupt. Images taken from Microsoft Office free for use pictograms.