Pooja Devrath

Background

About Pooja Devrath

As a seasoned professional in pharmaceuticals processes, I have extensive experience in collecting, monitoring, researching, assessing and evaluating information on the adverse effects of medication. I specialize in identifying new information about hazards associated with medicines and preventing harm to patients. My expertise also extends to the design, development, and maintenance of Clinical Database objects, ensuring the collection, integration, and availability of data at appropriate quality and cost. In my current role, I lead the Clinical Data Management team, where I oversee the team's activities, including discrepancy review, query generation, and resolution. I am responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines, identifying and raising protocol deviations in the database, and performing edit check validation by creating test cases and writing test scripts. I also carry out database validation (UAT) against the specified CRF/ECRF and manage clinical data management projects. As a Study Build Team member, I provide subject matter expertise in developing clinical study databases by building electronic case report forms (eCRF) and programming Edit Checks as per specifications in the EDC platform. I perform unit testing, technical review, and fix UAT issues if any. I also support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. I conduct technical reviews of databases developed by other Study Builders, support any updates or changes to the study (e.g. protocol amendments), conduct the change control process, resolve and update issues arising from UAT including study database, eCRF, and edit checks. Finally, I am responsible for conducting root cause analysis and coming up with preventive action. My passion for providing quality and cost-effective pharmaceutical solutions makes me a valuable asset to any organization. I am eager to apply my skills and experience in the pharmaceutical industry to help drive innovation, improve patient outcomes and contribute to the success of any team.