Srinivas Lanka

Background

About Srinivas Lanka

Knowledge of GCP/ICH Guidelines with FDA, EMEA guidelines. In depth knowledge of Clinical Trial Process, Clinical Data Management, Clinical Operations, Biometrics and Regulatory Medical Writing. Good experience in Statistical Analysis System (SAS) programming Profound knowledge on the CDISC standards for the submissions Created study mapping specifications and experienced in receiving, extracting data, transforming to SDTM and ADaM Datasets, and defining controlled terminology. Good knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials and different study populations. Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices. Strong interpersonal, written, and verbal communication skills.