Kathie Clark serves as the President of Kathie Clark Expert Services for Life Sciences, where she leverages over two decades of extensive experience in content management tailored specifically for the pharmaceutical industry. Her deep expertise encompasses the implementation of enterprise-level, validated solutions that have significantly...
Kathie Clark serves as the President of Kathie Clark Expert Services for Life Sciences, where she leverages over two decades of extensive experience in content management tailored specifically for the pharmaceutical industry. Her deep expertise encompasses the implementation of enterprise-level, validated solutions that have significantly enhanced operational efficiencies for major life science companies across the US, Europe, Japan, and Israel. Kathie specializes in critical areas such as document management, quality management systems (QMS), and electronic submissions, making her a sought-after consultant in the field.
In her current role, Kathie is instrumental in providing consulting services that focus on Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), regulatory compliance, and advertising/promotion technology. Her comprehensive skill set includes product management, professional services, and thought leadership, enabling her to guide organizations through the complexities of the life sciences landscape. Kathie’s strategic insights into business analysis and compliance ensure that her clients not only meet regulatory requirements but also optimize their processes for better outcomes.
Key projects under her leadership have involved the design and development of innovative solutions that streamline workflows and enhance data integrity. By integrating advanced technologies such as SharePoint and Documentum, she has successfully transformed how life science companies manage their documentation and quality processes. Kathie’s commitment to excellence and her ability to navigate the intricacies of the SDLC have positioned her as a trusted advisor in the industry, helping organizations achieve their goals while maintaining the highest standards of compliance and quality.