Divya Raavi

• Develop programming of Rave CRFs, folders, edit checks, derivations, integrations, migrations.
• Works effectively with vendor partners in testing and deployment under the supervision of Lead Programmer.
• Adheres to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
• Manages time effectively. Accurately estimates effort for tasks and meets agreed-upon deadlines. Adapts to frequently changing requirements, priorities, and schedules.
• Actively communicates with the management team and clinical teams regarding build activities.
• Adhered to strict change management policies when modifying existing systems or implementing new features in live environments for Lead studies.
• Work closely with the lead database developer in allocated tasks.
• Contribute to the development and testing of clinical databases in set-up phase.
• Contribute to the process of programming edit checks/dynamics/rules.
  
  
  
  

• Annotate CRFs, configure paper databases and eCRF, visit schedules, and edit checks.
• Based on the specifications, designing standard and non-standard eCRFs and generating a logical edit check program to find the data inconsistency for EDC studies.
• Perform the necessary quality control steps to confirm the study is built in accordance with approved specifications.
• Resolve and update issues arising from QC/UAT, including study databases, eCRFs, and edit checks.
• Design eCRF's as per protocol from scratch as study eCRFdesigner.

•Key activities include Test data creation ; UAT, Performing/ leading functional QC activities and
testing, Data validation and cleaning, Conduct third-party data reconciliations, SAE reconciliation, Database lock activities

•Creating Data validation documents, UAT Plan.
•Act as a single point of contact (internal expert) for specific processing task(s) on a project,
completeness, timely delivery and quality of clinical data.
• Being a SPOC working closely with the STL/as STL to provide suggestion required for a Revision request
changes.
•Handling the responsibility for allocation of work to CDAs as per FTE.
•Ensure to review the documents and data which are required for the Migration process as per
amendments in protocol or based on the request made by Sponsor.

•Conduct basic data review.
• Write data clarifications as directed by the Data Operations Coordinator.
• Resolve data clarifications, as directed by the Data Operations Coordinator.

• Conduct basic quality control procedures
• Meet personal project objectives, as assigned by manager.
• Escalate problems to the attention of the Data Operations Coordinator or Group Manager.
• Understand and comply with core operating procedures and working instructions.
• Understand, provide input to and comply with all applicable sections of Data Management Plan.
• Understand basic database structures.
• Develop and maintain good communications and working relationships with CDM team.