Smit S.

WORK HISTORY

EDUCATION

ABOUT SMIT S.

A leader in Clinical Data Management with 12+ years of experience across pharmaceuticals, diagnostics, medical devices, and contract research organizations. I have successfully built, scaled, and led CDM teams in multiple companies, from biotech startups to global pharmaceutical firms. My expertise spans oncology (solid tumors), stem cell therapies, autoimmune diseases, and CNS disorders, ensuring robust data strategies that drive clinical and regulatory success.As Head of the CDM department at GRAIL, I oversee the global data management strategy for early-stage cancer detection, FDA PMA submissions, post-diagnostic applications, and MRD. I collaborate with academic research organizations, commercial partners, and national health systems to optimize data acquisition, quality, and delivery. My experience includes handling real-world data (RWD) from electronic health records (EHRs), claims data, registries, and other healthcare databases, ensuring high-quality data collection, cleaning, and management for clinical research and regulatory compliance.I am deeply passionate about leveraging automation, AI, and advanced data science to transform clinical data workflows, improve efficiencies, and accelerate research timelines. I work closely with vendors and cross-functional teams to drive process optimization, data integrity, and innovation in clinical trials and post-market studies.Throughout my career, I have been instrumental in developing high-performing CDM teams, establishing best practices, and integrating cutting-edge data management systems. I am committed to driving data excellence in oncology and precision medicine to support breakthrough advancements in cancer detection and treatment.Key Skills & ExpertiseLeadership & Strategy: Heading the CDM department, building and developing CDM teams, process optimization, stakeholder collaborationClinical & RWD Expertise: Oncology (solid tumors), stem cell therapies, autoimmune diseases, CNSRegulatory & Compliance: FDA PMA submissions, BIMO audits, vendor assessmentsTechnology & Automation: Python, R, SAS, SQL, EDC development, data analytics, visualizationProject & Vendor Management: Financial budgeting, negotiations, technology/vendor assessments