Shubham Patil

• 2.5+ years of experience in clinical research activities deals with Image case processing actions.
• Collecting,analyzing and tracking clinical data from phase1,phase 2,phase 3 clinical trials.
• Query management.
• Patient report evaluation and data entry in clinical databases.
• Independently develop DM documents including but not limited to CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
• Independently lead data cleaning activities such as but not limited to Study Team data reviews, SAE reconciliation and non-CRF data reconciliation
• Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
• Detail oriented; performs quality and accurate work.
• Independently manage the database lock process in an efficient and timely manner
• Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21 CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols.

Worked as in-process quality assurance officer. Conducting pre and post manufacturing quality testing of pharmaceutical products along with in-process quality checks.

Followed GCP,GMP in quality checks.

Monitoring experience on Anti-diabetic, Oncological and anti retroviral drug manufacturing.