Senior Product Specialist - Gemstone

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Senior Product Specialist - Gemstone 

 

We are looking for a Senior Product Specialist!

 

Gemstone is Bayer’s global digital platform for managing clinical trial operations, built on the Veeva Vault Clinical Suite. It includes modules such as eTMF, CTMS, Study Startup, Site Connect and Disclosures. The goal of Gemstone is to enhance efficiency, transparency, and regulatory compliance in clinical development through integrated, cloud-based solutions. The platform is continuously evolving and plays a central role in Bayer’s digital transformation within Clinical Development Operations.

 

As a Product Specialist for Gemstone, Bayer’s global digital platform for clinical trial operations, you will play a key role in supporting the execution of digital solutions for study startup, trial master file management, and regulatory disclosures. You will assist with managing the product backlog, facilitate cross-functional collaboration, and help deliver compliant, efficient, and user-friendly solutions. This position requires a thorough understanding of clinical processes, regulatory guidelines, and digital systems, with the ability to translate business requirements into effective technical outcomes.

 

 

YOUR TASKS AND RESPONSIBILITIES:

 

• Product Lifecycle Support: Contribute to the management of the product lifecycle for Gemstone and VST, 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 and VST.
• 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 and VST integration landscape, identifying opportunities for system optimization and contributing to robust, scalable architectures.

 

 

WHO YOU ARE:

 

• At least 5 years of hands-on experience with Veeva Clinical Operations and the Veeva Vault Clinical Suite, with a proven track record as a product specialist or similar role in the pharmaceutical or life sciences sector.
• Strong understanding of clinical operations within the pharmaceutical industry, with practical exposure to areas such as Regulatory Affairs, Quality Assurance, or Commercial functions.
• Sound working knowledge of IT architecture and integration concepts, with the ability to contribute to the delivery and improvement of clinical trial technology solutions and ensure platform interoperability.
• Experience working collaboratively with cross-functional teams—including Clinical, Regulatory, Quality, and IT—to help develop compliant and efficient solutions.
• Awareness of GxP and quality compliance, experience assisting with product documentation, supporting SOPs