Omkar Walunj

ARGUS, AWS , Database Oracle, e-tmf documents, cloud based data management, specialist, CRM, Clinical trial specialist

Role
Clinical Representative at Sleepiz Ag
Location
Pune, IN
LinkedIn followers
500 followers
Sales & Business DevelopmentView LinkedIn profile

Experience

  1. Clinical Representative

    Sleepiz Ag

    Sep 2022 — Present · IN

    Working as a clinical representative for Pfizer, Jonson, and Jonson Kite Pharmaceuticals, and Glided-CDM management data analyses Argus Software AWS database- Marinating the data and analyzing the data- Collecting data using a planned methodology. Recording data with precision and accuracy. Analyzing data to conclude- The goal of clinical data management is to ensure that clinical trial data is of the highest quality and integrity and that it can be used to support decision-making throughout the drug development processOversaw the entire data management process for multiple clinical trials, ensuring data quality, accuracy, and compliance with regulatory standards (ICH-GCP, FDA).Led a team of data coordinators and clinical data analysts, providing guidance and training on data management processes and software tools.She has collaborated with clinical trial sponsors, investigators, and CROs to define data collection requirements and database specifications.Designed and implemented data validation plans and resolved data discrepancies promptly.Conducted regular database lock meetings and contributed to the preparation of regulatory submissions.

Education

  • Dy patil college of pharmacy

    M pharmacy

    2018 — 2018

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Omkar Walunj — Clinical Representative at Sleepiz Ag in Pune, IN | Unifers