Vijaya B.

Background

About Vijaya B.

7+ years of hands-on experience in Clinical Data Management and In-depth understanding of clinical study start-up, study conduct and study closeout activities. Proficiency in working as great team player on all phases of clinical trials, maintaining data integrity across the full stretch of study. Abilities to work on various therapeutic areas like Metabolic Disorders (NASH, NAFLD, Diabetes), Clinical Oncology, Health Supplements. Hands on experience in using EDC like Medidata Rave, Oracle Clinical and Inform. • Expertized in all 3 phases of clinical study and intricacies and guidelines associated with each phase study process. • Thorough understanding and adherence of guideline/regulations (GCP, ICH, FDA, WHO), Standards (CDASH, CDISC, 21 CRF Part 11), and company specific protocols. • Expertise in working for CRO through the full cycle of clinical study including startup, conduct, close-out, vendor quality reviews based on guidelines and set protocols, protocol deviations, query creation for issues raised and follow-ups. • Expertise in day-to-day activities including, data tracking, query/discrepancy management, data reconciliation, database edit checks, SAE reconciliation, lab data reconciliations for multiple studies under various phases of studies. • Experience in Team management, Vendor Management, Client Interaction and communicating with different departments within the clinical research domain. • Thorough understanding of minute details/differences the clinical study poses based on therapeutic areas of study which vary very much in study duration ranging from short duration acute disorders to long term studies like supplemental drug studies to manage lifelong illnesses. • Hands on skills to develop and deliver CRFs using available/reusable standard databases, develop DMPs and UATs with strict adherence to standards, guidelines and set protocols.