Chris Greenberg

About Chris Greenberg

Seasoned pharmaceutical professional with 25+ years\' experience in clinical supply chain systems. Highly effective people and project leader. Currently leading an organization within Clinical Trial Supply Management consisting of three sub-teams (IRT, CTSM Systems, and Demand Planning & Analytics). Responsible for, or contribute to, many company-wide process, systems or data initiatives. During my tenure at Janssen I held the role of the Business Owner within Clinical Supply Chain Systems for all systems supporting the CAR-T program. Overall, I have 7 years\' experience supporting individualized therapies. I am a subject matter expert for the implementation of IVR/IWR systems. Over 25 years of experience developing IVR/IWR systems for use in clinical trials working on the supplier side and the sponsor side. Over 19 years of personnel and vendor management experience. I have worked on studies from Phase I through Phase IV across all therapeutic/disease areas. Direct experience with internal and external audits (e.g. FDA), as well as conducting vendor evaluations and audits. I am well versed in the development of SOP\'s and other procedural documentation to support systems and/or processes. Largely responsible for the development of a reconfigurable IVRS/IWRS implemented seamlessly across two preferred suppliers with heavy data integration requirements while at BMS. A key contributor to the implementation of the Medidata Balance product within Janssen.

Experience

1. Senior Director Ctsm Systems and Analytics

   BioNTech SE

   Jan 2024 — Present

   Strategic direction setting, roadmap release planning and deployment of software solutions for Global CTSM (e.g, SAP for use in clinical supply, clinical demand planning software, individualized therapy systems) in the clinical area but also in the BioNTech-wide non-clinical area (operational areas like manufacturing, supply chain management).• Liaises with internal and external stakeholders when escalations are needed.• Liaises with internal and external stakeholders to identify additional cross-functional initiatives / new ways of working.• Defines and implements performance objectives for Global CTSM Systems & Analytics function.• Defines and leads implementation of Global CTSM Systems & Analytics function process initiatives.• Supports and leads global initiatives like handling of (standardized) data as well as their evaluation and provision for other functional units (e.g, GDO Center of Data Excellence).• Manages budget and performance management for Global CTSM Systems & Analytics function.• Leads Global CTSM Systems initiatives implementation cross-functionally on a global level.• Ensuring GxP / regulatory compliance for all systems in scope.• Provides oversight and guidance for sub-function responsibilities (IRT, CTSM Systems, and Demand Planning & Analytics).

Education

• The Chubb Institute

  Certificate Program, Computer Programming

  1997 — 1999

• Stockton University

  Bachelor of Arts (B.A.), Business Management/Performing Arts

  1988 — 1992

Skills

• Clinical Research
• Integrated Water Resources Management
• Clinical Supplies
• Clinical Development
• Ich-Gcp
• Unblinding
• Sas Programming
• Drug Supply Management
• Clinical Data Management
• System Design
• Biotechnology
• Validation
• Ivr
• 21 Cfr Part 11
• Clinical Trials
• Clinical Systems Implementation
• Regulatory Affairs
• Staff Management
• Ivrs
• Pharmaceutical Industry
• Fda
• Drug Development
• Project Management
• Randomization
• Therapeutic Areas
• Ctms
• Iwrs