Ankita Shethna

WORK HISTORY

EDUCATION

ABOUT ANKITA SHETHNA

Experienced Clinical Data Manager with a strong ability to work under deadline pressure, on multiple projects simultaneously with sound judgment, to work in a dynamic, cross functional team environment, flexible enough to manage change as needed. I am skillful in the understanding of ICH GCP, GCDMP, and Six Sigma processes. Proven competency in collaborating with Clinical Research Associates (CRA\'s), Medical Monitoring team, Data Management teams, critical stakeholders for electronic Case Report Forms (eCRF\'s), Validation & Analysis Plans (VAP\'s), Data Handling Plans (DHP\'s), and so on. I possess demonstrated experience in executing a broad spectrum of clinical data management tasks for the smooth running of clinical trials, User Acceptance Testing (UAT) of the database, processing clinical safety and efficacy data from clinical trials. I have work experience in CRF design; Edit checks creation, vendor Reconciliation, data cleaning and query process, SAE Reconciliation, CRF tracking, Database QC, Database Audit. Effective and results-driven leader with extensive expertise in Clinical Data Management in Oncology with project management skills and advanced clinical data management knowledge in both tools and processes. Proven organizer, motivator, and contributor to organizations with a history of success supporting and achieving organizational objectives. I am experienced in effective CRO oversight with strong knowledge and background in GCP and ICH guidelines.