I studied piano performance and toxicology, and am now Master Data Manager at Bayer Pharma in the R&D Master Data Management team of Data Science & AI. I am passionate about team collaboration and rowing. Currently, I'm co-leading the IDMP Ontology, an international cross-industry project with 12 pharma companies for the unique identification of medicinal products to ensure patient safety. Talk to me about common standards and high quality data for better ML and AI outcomes, our next collaboration project, and/or our next jam session at the Bayer Berlin campus.

Experienced leader in development, validation, and implementation of clinical trial software and processes

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.

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.