Spandana gopu

Provide professional DM input on Clinical Trial Team. Responsible for the Validation and Analysis Plan meeting for the clinical trial, Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks. Review and contribute to preparation of protocols( data management section, visit schema and study design). Prepare Case Report Forms and CRF completion Guidelines.

Perform database, edit check testing activities, data review and query generation. Update the database to correct errors. Participate in completion of all activities necessary for the finalization and transfer the clinical database and related project documents to the sponsor. Act as a lead CDM for assigned projects, Assist in identifying the achievement of milestones. Develop and design CRFs, or participate in the review of sponsor-generated CRFs. Assist in the review of the database design.