Monish Shetty

Background

About Monish Shetty

Successfully managed CDM aspects of international clinical trials on Oncology, Respiratory, Vaccines, Diabetes, Pain, Neurological System and Rheumatoid Arthritis across multiple clients. • Clinical data scientist / Senior data manager role in clinical trials for major pharmaceutical organizations like Pfizer, Genzyme, MedImmune, Sanofi-Aventis, Boehringer Ingelheim, GlaxoSmithKline & Roche. • Experience in managing end to end clinical data management activities from setting up a study to study closeout in SDTM and CDASH standards. • On-site coordinator (Netherlands) as the oversight liaison between the client team based in EU & US and internal offshore team to ensure project-specific information and ongoing updates are proactively communicated, ownership of the deliverables, allocation of work, maintenance of data quality/documents, adherence to client SOP’s, audit and level 2 contact for escalation of repeated delivery issues. • Domain consultant for developing client applications, trainer for client specific process and applications with creation of training materials. • Involved in process improvement activities (Green belt, Lean six sigma, excel macro based tool for Lab reconciliation, Study lock status tracker, Visit status tracker created for CRA’s for multi-centric global study, Study setup project planner) • Hands on experience on multiple clinical applications: Inform, Oracle Clinical, OC-RDC, Rave, Integrated review, Oracle discoverer, TIBCO Spotfire, client specific ETMF and Eclipse. • Ability to attain, maintain and apply a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures. • Knowledge or ability to rapidly gain knowledge with programming/query languages. • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations • Ability to prioritize activities and consistently meets deadlines according to accepted levels of quality, paying attention to details • Ability to prioritize and to adapt quickly to changing business conditions plus a “can-do” attitude • Logical thinking, attention to detail, good organizational skills, and problem-solving abilities • Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices) • Good communication skills with the ability to communicate with both the technical and business areas • Excellent problem-solving skills and ability to think creatively