Senior Product Specialist - Gemstone Diamond (Veeva Clinical Data Management)

Gemstone Diamond is Bayer’s global digital platform for managing clinical trial data management and electronic data capture, built on the Veeva Vault Clinical Data Management Suite. It is a key system in the IT landscape for Clinical Development Operations and plays a central role in Bayer’s digital transformation within Clinical Development Operations.

• At least 5 years of hands-on experience with Veeva Clinical Data Management Suite with a proven track record as a product specialist or similar role in the pharmaceutical or life sciences sector.
• Strong understanding of clinical data management operations or related pharmaceutical domains.
• Sound working knowledge of IT architecture and integration concepts.
• Experience working collaboratively with cross-functional teams including Clinical, Regulatory, Quality, and IT.
• Awareness of GxP and quality compliance.
• Experience assisting with product documentation, supporting SOPs, and maintaining regulatory requirements for platforms such as Gemstone Diamond.
• Proficient in stakeholder communication, including preparing updates and basic performance metrics.
• Strong communication and presentation skills.
• Proficiency in English (both written and spoken).
• Bachelor’s degree in science, information technology, or a related field.

Product Lifecycle Support:

• Contribute to the management of the product lifecycle for Gemstone Diamond, including assisting with concept development, MVP strategies, scaling and continuous improvement.

Integration Coordination:

• Participate in integration initiatives by identifying potential issues, performing root cause analysis, and supporting prompt resolution to ensure smooth interoperability across platforms.

Risk and Impact Analysis:

• Conduct impact assessments for system changes or updates, evaluate associated risks, and recommend mitigation strategies to uphold compliance and operational stability.

Cross-Functional Collaboration:

• Work closely with teams from Clinical, Regulatory, Quality, and IT to ensure solutions are compliant, efficient, and aligned with stakeholder needs.

Business-Technical Bridge:

• Facilitate communication between business solution managers and technical teams, helping to align business objectives with technical solutions.

GxP and Quality Support:

• Support adherence to GxP guidelines, assist in preparing and maintaining product documentation, and contribute to the implementation of internal SOPs and quality standards for Gemstone Diamond.

Platform Expertise:

• Apply advanced knowledge of Veeva products and the Veeva Vault Clinical Suite to assist with platform enhancements, troubleshooting, and user adoption efforts.

Integration Landscape Awareness:

• Maintain an understanding of the Gemstone Diamond integration landscape, identifying opportunities for system optimization and contributing to robust, scalable architectures.