Akshatha VS

• Worked in various Studies as a Data Operations Co-Ordinator (DOC) and as a reviewer in Therapeutic areas like Gastrointestinal, respiratory and Oncology, Neurology, Oncology, psychiatry.

• Drafted and reviewed the Study documents like Data Management Quality Plan (DMQP), Data Management Quality Control Plan (DMQCP) Completion Guidelines, Financial reports on monthly basis.

• Perform the role of Data Reviewer and running query report from DB and working on answered queries, open queries and manual queries regularly to meet the query TAT. Reviewed data for Vendor reconciliation, SAE reconciliation.

• Performed the Validation of Critical Edit Checks in User Acceptance Testing (UAT) environment during the Study Go-Live.

• Performed the Data entry and Validation of various Study Custom reports like Audit Trail reports, Serious Adverse Event (SAE) reports, EDC Cleaning Plan, MDR reports and coordinated with the Programmers, Coders and Medical Data Reviewer teams to meet timelines.

• Performed Query Quality Review (QQR) and Listings Quality Review (LQR) both as a Reviewer and Operations Lead and ensured to maintain the quality of the trial.

• Supported the Studies by providing the Weekly or Monthly Status reports , Clean Patient Tracker (CPT) and managed to inform the team on the status of the study trial.

• Understands how to raise Data Handling Entry, review and approval process.

• Mentored the new resources and helped them in onboarding to the Study activities.

• Develop and maintain good communication and working relationship with the team.