Experience

Tech Observer

• United States
• Business Consulting and Services
• 200 - 300 Employee

• Clinical Data Coordinator

  • Aug 2021 - Present

  Reviews CRF as per protocol and project specific documents. Responsible for preparing project specific documents. Handling requests/issues by the clients and team in coordination with PM. Coordination with CDA in UAT leading to robust database design. Performs UAT of edit checks as a part of database validation. Performs data review in EDC database for the assigned project. Conducts project and process specific training for subordinates. Responsible for initiating project specific DMTMF and e-filing and reviewing it on an ongoing basis. Acting as a back up for Data Manager. Show less



CDSA, Inc.

• United States
• Non-profit Organizations
• 1 - 100 Employee

• Consultant Data Manager

  • Jul 2020 - Jul 2021

  • EDC Database designing and edit check specifications • Data review in EDC (Electronic data capture) database for the assigned project/study. • Creates and enters test data for User Acceptance Testing (UAT) • Reviews and adheres to the requirements of study specific DMP for assigned project(s) and updates as required. • Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines. • Reviews database design specifications (including configuration, data structures, annotated CRFs). • Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. • Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. Show less



JSS Medical Research

• Canada
• Biotechnology Research
• 300 - 400 Employee

• Data Analyst/ Validation Associate

  • May 2017 - Jul 2020

  • Review of Data validation plan and updation if required • Check Testing and preparation of Check testing form • Query generation and updation of Query Resolutions in the database • Preparation of query tracker including SEC tracker and validation tracker • Performing Ongoing QC and Final Inspection • QC Form updation and reverification • External Lab data Reconciliation • Preparation of Project status tracker on weekly basis • Review of Data validation plan and updation if required • Check Testing and preparation of Check testing form • Query generation and updation of Query Resolutions in the database • Preparation of query tracker including SEC tracker and validation tracker • Performing Ongoing QC and Final Inspection • QC Form updation and reverification • External Lab data Reconciliation • Preparation of Project status tracker on weekly basis



JOY Skincare Beauty and Wellness

• Philippines
• Wellness and Fitness Services

• Quality Control Analyst

  • Jul 2014 - Nov 2015

  • Quality check of raw materials of different batch of products • Quality check of finished product of each and every batch • Quality check of labeling and packaging • Quality check of raw materials of different batch of products • Quality check of finished product of each and every batch • Quality check of labeling and packaging