Yusra Fatima

About Yusra Fatima

Clinical Data Manager with nine plus years of expertise overseeing data management in phases 1-4 of clinical trials within pharmaceutical and clinical research organizations. Proven track record of efficiently utilizing Medidata\'s Rave platform and its diverse modules for streamlined data collection and reporting. Adept at ensuring compliance with regulatory standards and implementing effective data management strategies. Experienced in collaborating cross-functionally to deliver high-quality, accurate, and timely clinical trial data. My SAS & SQL skills in data management activities, which includes writing programs for query generation & producing reports. Skills includes: • Experience in multiple EDC tools (iMedidata Rave and its functionalities, InForm, Trial Master, Oracle, Pheedhit and Clinion etc.) • Experience in Veeva (eTMF), HPALM and SAS software application • Basic knowledge of SAS and SQL for data cleaning, manipulation & data reporting • Database Design, UAT, Validation and Report Generation & Effective Query Writing • Project Management experience in Clinical Data Management • Experience in RECIST • Knowledge of Medical coding dictionaries (MedDRA & WHODD) • Knowledge of CDISC and SDTM and Excel • Knowledge of industry standards-ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines. • Involvement with cross-functional teams, including Programming and Biostatistics • Strong Analytical and Problem-Solving Skills

Experience

1. Senior Clinical Data Analyst

   Symbio

   Feb 2023 — Present · Port Jefferson Station, NY, US

   Responsibilities Undertaken:• Review of study specific protocols and annotated CRFs/eCRFs• Perform in depth clinical data review of study patient information• Requires the ability to run data validation programs, identify, recommend program modifications/edits, generate and track queries, and maintain/reconcile protocol violation listings• Manage creation of tables, lists, & figures (TLFs) for output of safety & efficacy analysis• Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL)• Write internal and external data queries for paper-based studies, and write and post manual queries within EDC systems• Support data managers with study changes/updates, complex scenarios and high level data reviews• Assist with database lock activities• Draft various data management documents, such as but not limited to: Data Management Plan (DMP), CRF Completion Guidelines (CCGs), Data Validation Plan (DVP), Protocol Violation/Deviation Logs, etc.• Provide review of draft protocols and (e)CRFs to client in conjunction with other study team members• User Acceptance Testing (UAT) in conjunction with Clinical Database Manager, or designee, as needed

Education

• Jamia Millia Islamia University

  Postgraduate Degree

  2010 — 2012

• Jamia Millia Islamia University

  Bachelor's degree

  2007 — 2010