Rashmi Hiremath

Experience

• 

  IQVIA

  Feb 2014 - Jul 2021

  Clinical Data Programmer

  Work on Rave as a Study designer. Plan, coordinate database design, development, maintenance of clinical systems. (Study Design) Program, test, and document databases in accordance with programming standards. Reviewing CRFs. Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems. Program, test, and document databases in accordance with programming standards and validation procedures. Program database manipulation and transfers of data for internal and external clients. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned and interact with the project team to organize timelines, responsibilities and deliverables. Provide technical expertise in conjunction with internal and external clients. Programming/Building Edit checks as per study requirements. To work for Quality reviewer and tester for certain projects. Working as a QR and QT. Documentation of clinical trial data. Total commitment to quality and attention to detail & Contributing to best practices and process improvements. Performing Migrations in RAVE Tool. Knowledge of ICH-GCP and other clinical guidelines Knowledge of all phases (Phase I -IV) of clinical trial. Good knowledge of ICH-GCP guidelines. Good knowledge of clinical trial processes and documentation of clinical trial data. Good knowledge of working in RAVE i.e. complete study builds and Edit checks, eSAE mapping/RSG mapping Good knowledge of Drug regulatory affairs (clinical trials) and EC submission.  Good Knowledge of Quality Review. Good Knowledge of Quality Control Show less

• 

  PPD

  Aug 2021 - Jan 2023

  Cdm programmer ll
• 

  IQVIA

  Feb 2023 - now

  Database Management Specialist