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
Experience
Clinical Representative
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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