Grace Kowalik
About Grace Kowalik
Grace Kowalik is the Associate Director of Compliance and Quality Innovations at Takeda and the Senior Manager of CDR&A, Global Data Management and Centralized Monitoring at Bristol-Myers Squibb, with over 20 years of experience in clinical trial management.
Current Positions
Grace Kowalik currently holds two significant positions in the pharmaceutical industry. She is the Associate Director of Compliance and Quality Innovations at Takeda in the United States. Additionally, she serves as the Senior Manager of CDR&A, Global Data Management and Centralized Monitoring at Bristol-Myers Squibb, located in Lawrenceville, NJ.
Professional Background
Grace Kowalik has over 20 years of progressive experience managing clinical trials involving 3,000 to 5,000 patients for leading pharmaceutical companies. Her career includes substantial roles at Novo Nordisk, where she held positions such as Senior Manager of Strategy and Operational Effectiveness (2015-2018), Principal Clinical Data Analyst and Team Lead in Data Management (2008-2015), and Lead Clinical Data Manager (2000-2008), all based in Princeton, NJ.
Education and Certifications
Grace Kowalik's educational background is comprehensive and diverse. She holds an MS in Economics from Warsaw University of Life Sciences – SGGW in Warsaw, Poland. She also earned a Diploma in Computer Programming from The Chubb Institute. Additionally, she has received certifications from SAS Institute (Certificate in SAS Programming) and the Oracle Institute (Certificate in Oracle Clinical System Release 4.0).
Technical Skills and Expertise
Grace Kowalik is proficient in various technical tools and programming languages including SQL, PL/SQL, SAS, Tableau, Spotfire, SAP Dashboards, Crystal Reports, and JReview. Her strong understanding of relational databases complements her ability to develop KPIs, metrics, and quality dashboards. These skills enable her to track progress, quality, efficiency, and compliance effectively in clinical data management.
Leadership and Responsibilities
In her roles, Grace Kowalik is responsible for leading data management process oversight and ensuring the execution of prioritized CDM or cross-functional processes. This includes the timely delivery of quality study databases. She manages a team of Compliance and Quality Innovation specialists and coordinates the development of various TAUs or Study teams based on portfolio priorities, demonstrating her leadership in the pharmaceutical industry.