Sameer Ali

Background

About Sameer Ali

I've spent a decade in the healthcare industry, with over seven of those years diving deep into Core Clinical Data Management (CDM). Throughout my career, I've taken the reins on studies across all phases, from the initial startup and conduct to the final closeout. One of my key strengths lies in crafting comprehensive study documents, including the Mock CRF, Study Specification documents, Edit Check Specifications, eCGs, Data Handling Plans, and Data Transfer Specifications. I'm not just about paperwork, though; I've got a solid track record in overseeing Clinical Research Organizations (CROs) and hands-on experience with some of the leading CDM tools like Oracle Clinical, Medidata RAVE, and Inform. I've planned and executed studies from Phase I to Phase IV across various therapeutic areas, such as Oncology, Respiratory, Cardiovascular, and Immunogenicity. Managing multi-centric studies with high subject volumes and ensuring compliance with CDISC standards for key submission-critical studies are all part of my day-to-day. In terms of documentation, I've made significant contributions to the Trial Master File (TMF) and have a knack for ensuring start-up studies are delivered within tight timelines. My focus is on seamless database delivery, which involves active participation in the User Acceptance Testing (UAT) process, and excelling in data freezing and locking within the agreed timelines for statistical review and other crucial DM milestones. I bring a wealth of knowledge across Clinical Research, Coding, and Clinical Data Management Systems (CDMS). Leading and coordinating cross-functional teams, including Database Programmers, Clinical, Coding, and Biostatistics teams, both internally and externally, is something I take great pride in.