Avantika B.

About Avantika B.

Detail oriented Clinical Data Manager seeking an opportunity that will help to contribute…

Experience

1. Clinical Data Manager

   IQVIA

   Jul 2023 — Present · IN

   Provide strategic data management input across multiple clinical trials from start-up to closeout.Lead development of eCRFs, CCGs, Data Quality Plans (DQP), and user acceptance testing.Manage and perform SAE reconciliation and local/3rd party lab data reviews.Generate and present study status reports to cross-functional teams.Supervise and mentor a team of junior clinical data managers, providing guidance on project deliverables.Collaborate closely with Senior Clinical Data Managers to ensure alignment with clinical program needs.Support creation of study specification worksheets and data integration plans.Led DMP quality review meetings, mitigating potential sponsor escalations and enhancing validation processCollaborated with cross-functional teams and external vendors, ensuring alignment with study timelines and milestones.Conducted documentation review including Architect loader spreadsheets and UAT execution.Spearheaded data acquisition and management across six global Phase II & clinical studies, including setup, conduct, and closeout activities.Led the setup and verification of External Data Streams, including lab and biomarker data for ingestion into clinical data repositories.Developed trial-specific data workflows and collaborated with vendors to establish data transfer agreements and review specifications.Conducted CRF design, protocol and ICF review in line with global regulatory standards and sponsor requirements.Resolved over 40 protocol non-compliance data issues, ensuring timely and accurate data availability.Facilitated and led Data Management Plan (DMP) quality reviews to support risk mitigation and issue escalation pathways.Designed a two-way approval system to enhance vendor/site data flow accuracy.Mentored junior data managers on SOPs, trial-specific data workflows, and external data setup procedures.Managed SAE and local lab reconciliations, maintaining real-time inspection readiness.