AMITESH KUMAR

Directing database management initiatives for global clinical studies, leading cross-functional teams of 30-40 people, and driving project initiation, stakeholder alignment, and governance activities.

Led end-to-end clinical data management activities across global studies, including study start-up, database design, edit check specifications, user acceptance testing, and database lock readiness.

Administered clinical data management activities across assigned studies, supervised project delivery teams, and managed performance evaluations and capability development.

Coordinated clinical data operations across assigned studies, provided backup leadership support, and managed operational dashboards, patient tracking, and study review reports.

Designed database documentation, executed user acceptance testing and database validation, and performed data cleaning, SAE reconciliation, and external data reconciliation activities.

Directed team management and resource planning, managed clinical data management operations across the study lifecycle, and led mentoring and knowledge development programs.

Executed study setup activities including database annotation, configuration, edit-check development, validation, and user acceptance testing, and supported study conduct through query management and reconciliation.

Coordinated clinical trial activities on a day-to-day basis, supported site feasibility, selection, initiation, monitoring, and closeout, and maintained Trial Master File documentation.

Coordinated site-level clinical research activities, managed participant screening, enrollment, and visit scheduling, and maintained clinical records and regulatory documentation.

Completed a certification on Generative AI Overview for Project Managers, focusing on AI applications in project management.

Earned a Certificate in Data Science with a focus on Business Analytics and Artificial Intelligence.

Pursued an MBA with a focus on project management, enhancing skills in strategic planning and operational leadership.

Completed a Certificate Program in SAS, developing skills in statistical analysis and data management.

Earned a Professional Diploma in Clinical Research, covering essential aspects of clinical trial management and regulations.

Completed a Master of Science in Biotechnology, gaining advanced knowledge in biological sciences and research methodologies.

Earned a Bachelor of Science in Chemistry, building a strong foundation in chemical principles and laboratory techniques.