Shah Ashraf

Background

About Shah Ashraf

Sr TMF Quality Specialist, Trial Master File(TMF/eTMF/Document Management)A TMF Geek, always hungry of developing new ideas to make the work flow smooth-Experience in the use and development of hard copy files/electronic documentation and electronic TMF-Strong working knowledge of ICH/GCP Guidelines-Plan and coordinate the management of the Trial Master File and associated processes, including system and tool development and business processes documentation. Maintain documentation control systems for compliance with FDA regulations-Familiar with Data management processes review/QC Data, lab research-In-house audit/QC of TMF-Ultimate responsible to ensure submission and inspection readiness for the TMFSpecialties: Clinical/Regulatory Document ManagementSet up and development of Trial Master Files as per "New Industry Standard DIA Model" Scanning/OCR/Indexing/ArchivingBroad knowledge of document management processes and procedures, electronic documentation systems, data retrieval, and electronic file formats.Have extensive experience using Adobe Acrobat Professional, ISI Tools, MS Access, Excel, PowerPoint, SharePoint, Visio, CTMS and Web-based document indexing and viewing applications.Member of MHRA ForumsMember of CDISC and DIA TMF Ref Model (Sub-Artifact Group) Member of OASIS interoperability modelBlog: http://shahashrafblog.wordpress.com/