Smit S. Email & Phone Number

Director of Clinical Data Management at GRAIL, Inc., a company that develops multi-cancer early detection tests. I have 12+ years in pharmaceuticals, diagnostics, medical device and contract research organization. Thriving in diverse settings, from biotech to global pharma.I oversee the data management strategy in US and Global regions for early stage cancer detection towards PMA for FDA submission, Post Diagnostic and MRD space collaborating with academic research organizations, commercial partners and national health systems on data acquisition, quality, and delivery. I lead and mentor clinical data management teams across multiple clinical programs. I have experience with acquisition and handling of real-world data (RWD) including various sources of RWD such as electronic health records (EHRs), claims data, registries, and other healthcare databases. In my role, I oversee the processes involved in collecting, cleaning, and managing RWD for research and analysis purposes.I'm deeply enthusiastic about leveraging data and technology to push the boundaries of diagnostics and enhance patient outcomes. Continuously seeking opportunities to expand my skill set and tackle fresh challenges within this dynamic and ever-changing industry drives my professional journey. I am dedicated to nurturing and guiding clinical data management teams, fostering collaboration with vendors, and playing a pivotal role in planning and development of automation features that drive innovation in clinical data management systems and tools. Ultimately, my mission is to contribute significantly to the success of projects, ensuring data integrity and regulatory compliance while advancing the field of clinical research.Skilled in Leadership, Process Improvement, SOP Development, Team Management, Stakeholder Collaboration, Project Management, Technology/Vendor Assessments and Financial Budgeting & Negotiations, FDA Inspections, BIMO Audit Process, Vendor Audits.Technical Proficiency:Skilled in Python, R, SAS, SQL, EDC Developer, Data Analytics, Data Visualization, and expertise in crafting Data Transfer Process & Plans.