Smita D.
About Smita D.
Smita D. is an Associate Director at Bristol Myers Squibb with extensive experience in clinical research and management of CTMS, eTMF, and EDC systems.
Current Role at Bristol Myers Squibb
Smita D. is currently serving as Associate Director at Bristol Myers Squibb in the United States. In this role, she manages CTMS, eTMF, and EDC systems. Her responsibilities include overseeing clinical trial management, ensuring compliance with regulatory standards, and managing clinical data.
Previous Roles and Experience
Smita D. has held a variety of positions in the field of clinical research. She was a Senior Clinical Scientist and Clinical Scientist at Merck in the U.S. from 2020 to 2022. Prior to that, she worked as a Regional Clinical Trial Manager at Amgen. She also has experience as a Clinical Site Manager at Bristol Myers Squibb from 2018 to 2020 in Lawrenceville, NJ. Earlier roles include Program Development Analyst at Rutgers University–New Brunswick, Research Associate & Trainer at Rutgers Robert Wood Johnson Medical School, and Research Associate at Robert Wood Johnson University Hospital.
Educational Background
Smita D. holds an MS in Clinical and Translational Sciences from Rutgers Biomedical & Health Sciences, GSBS, achieved between 2014 and 2016. She also holds a Certificate in Pharmaceutical and Clinical Trail Management from Rutgers, The State University of New Jersey-New Brunswick, obtained in 2013. Additionally, she earned a Doctor of Medicine (MD) and a Bachelor's Degree in Indian Medicine from the University of Mumbai.
Areas of Expertise
Smita D. has extensive expertise in managing first-in-human studies, particularly in hematological malignancies. She has developed essential study-level documents such as Protocols, ICFs, DSUR/PSUR, and Investigator's Brochures. Her skill set includes handling regulatory submissions, project coordination, resource planning, and vendor management. She is highly knowledgeable in ICH GCP guidelines and has proven competencies in executing research studies through various phases.
Regulatory and Ethical Compliance
Committed to high-quality and ethical practices in clinical research, Smita D. adheres strictly to ICH-GCP and FDA guidelines. She has experience providing responses to regulatory authorities and IRBs, ensuring that all studies are conducted in compliance with industry standards. Her work reflects a strong commitment to ethical conduct and rigorous research methodologies.