Vishal Yerekar

Design and develop efficient predictive models and machine learning algorithms. Performed exploratory analysis of data sources to identify new business problems. Developed end-to-end machine learning model and scale them to run in production environments. Worked on multiple projects for a pharmaceutical client including bag optimization for vaccine production and transportation model. Hands on experience in eTMF and CTMS system. Manages the set up and maintenance of eTMF in accordance with TMF process (Study, Country and Site artifacts). Analyze the clinical trial documents, classifying them into pre-determined sub-classes according to the Regulatory specifications of the Client and FDA. Monitor filing accuracy and compliance to customer file plan or SOPs. Conduct review/ Gap analysis for eTMF.

Identification, naming and categorizing of all type of documents (Clinical/Non-Clinical/Regulatory). Conduct quality check of all the documents, rectifying the errors before submitting the work for execution. Resolved query log, conducted update session and sharing the resolution with processor.

Interpretation, analysis and organization of clinical trials (ongoing, completed, published) obtained from different sources as media releases, company/university/Institution sponsored publications, authentic clinical trials data sites with respect to drugs in focus, diseases or conditions for therapy/prophylaxis, other important medical details (trial phase, drug dosages, etc) in a form ready to use for the end-users.