Yusra Fatima Email and Phone Number
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
Symbio Proinnovera
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Senior Clinical Data AnalystSymbio Proinnovera Feb 2023 - PresentPort Jefferson Station, New York, United StatesResponsibilities 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
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Clinical Data ManagerSyneos Health Mar 2021 - Feb 2023IndiaResponsibilities Undertaken:• Interacts with other Data Operations teams as a functional lead representative.• Prepare and update sections of the clinical trial protocol• Prepare Case Report Form as per CDISC and SDTM requirements according with the protocol and the database• Reviews and defines CRF/eCRF database design specifications• Creates and updates the CRF/eCRF Completion Guidelines• Development of edit checks specifications and creating test steps for testing• Performs User Acceptance Testing (UAT) for data entry screens, edits check• Using SAS tool for data management, which includes writing programs for cleaning and reporting of study data as well as generating analytical datasets.• Performs data collection, data cleaning and data reporting activities along with QC to each stage in the data handling to ensure the data are reliable• Resolves answered queries and re-queries where appropriate• Performs Serious Adverse Event (SAE) reconciliations/Vendor Recons• Updates the Data Management Plan under the guidance of the PDM• Co-ordinate with Medical coding team for coding related activities• Generating tables, listings, and figures (TLFs) for regulatory submissions.• Performing Data base closure activities as per Project Plan• Archival of all the study related documents in compliance with ICH-GCP -
Lead Data ManagerTata Consultancy Services Oct 2019 - Jan 2021Mumbai, Maharashtra, IndiaResponsibilities Undertaken:• Managing all data management deliverables for assigned studies• Maintains full understanding of protocol designing and finalization• Presentation of the database to relevant internal and external stakeholders• Review Case Report Form as per CDISC and SDTM requirements according with the protocol and the database• Reviewing eCRF specification prepared by Clinical Data Manager• Review and finalizing eCRF completion guidelines• Reviewing DVR specifications and test steps• Reviewing UAT plan, UAT performance and UAT report by Clinical Data Manager• Reviewing and maintenance DMP matrices• Development of new processes and SOPs pertinent to data management• Monitoring and reviewing discrepancy management along with Medical coding activities• Monitoring and supporting SAE reconciliation and Vendor data reconciliation• Interact with other project team members, including training Data Management Assistants and Data Management Associates• Communicate with clients and site on DM issues• Performing and monitoring freezing and data base lock activity -
Validation Analyst- Clinical Data ManagementJss Medical Research India Private Limited Feb 2014 - Oct 2019Haryana, IndiaResponsibilities Undertaken:• Assist in Protocol development and CRF designing as per CDISC and SDTM• Database designing as per CRF and protocol• Prepare Data Validation Plan and implementation of edit checks as per study requirements• Prepare CRF/e-CRF filling guidelines and assist in DMP creation• To perform the query generation/ resolution and maintain study specific tracker• Performing data base lock and freezing -
Process AssociateMax Neeman International Jul 2011 - Feb 2014IndiaResponsibilities Undertaken:• To perform 250 pages of data entry per day with minimal errors• To enter the Laboratory data in the clinical database• To perform the Database Screen testing• Raise the Data Entry Alert Forms during data entry if any errors found• Signature & date the front sheet of the CRFs after data entry completion
Yusra Fatima Skills
Yusra Fatima Education Details
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Bioinformatics -
Biotechnology
Frequently Asked Questions about Yusra Fatima
What company does Yusra Fatima work for?
Yusra Fatima works for Symbio Proinnovera
What is Yusra Fatima's role at the current company?
Yusra Fatima's current role is Senior Clinical Data Analyst @Symbio Proinnovera, GCP Certified I MSc Bioinformatics.
What schools did Yusra Fatima attend?
Yusra Fatima attended Jamia Millia Islamia University, Jamia Millia Islamia University.
What skills is Yusra Fatima known for?
Yusra Fatima has skills like Pharmaceutical Industry, Clinical Trials, Lifesciences, Clinical Research, Molecular Biology, Clinical Development, Drug Discovery, Cell Culture, Data Analysis, Cro, Biotechnology, Gmp.
Who are Yusra Fatima's colleagues?
Yusra Fatima's colleagues are Dr. Andreas Pfaff, Cindy Shirah, Chintan Arora, Rosemarie Panico, Sade Adegun, Tom Mcguire, Dr. Veronika Bäcker.
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Yusra Fatima
Journalism Student And Vice President Of Student Council At St.Mary’S College | Public Speaking | Current Affairs | Social Media ManagementHyderabad -
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Yusra Fatima
Delhi, India
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