Shah Ashraf

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/

Experience

1. Manager Tmf Quality

   TransPerfect

   Feb 2018 — Present · New York, NY, US

Education

• Barnett International A Division of Cambridge Innovation Institute

  Clinical Research Auditing Certification, Clinical Research Auditing

  2016 — 2016

• Doccucomp (healthcare compliance & education)

  Certificate, Clinical Documentation for ICD 10

  2011 — 2011

• Pusa College India

  Associate's Degree, Biology/Biological Sciences, General

  1982 — 1984

• Food and Drug Administration’s Office of Medical Policy and the Duke University School of Medicine

  Certificate in FDA's Clinical Investigator Training Course, Clinical Trials / Regulatory Requirements

  2014 — 2014

• All India Institute of Medical Technologist, Salt Lake City, Calcutta-87, India

  Diploma, Medical Laboratory Technology

  1988 — 1989

• Ashford and St. Peter's Hospitals NHS Trust

  Certification; International Conference on Harmonization, Good Clinical Practice Guideline Course., ICH, GCP

  2013 — 2013

• Raritan Valley Community College

  Certification, CLINICAL TRIALS ASSISTANT & ICH VS FDA CLINICAL REQUIREMENTS

  2010 — 2010

• St Patrick's School, Asansol West Bengal INDIA

  ICSE, English, Biology, Maths, Social Studies, Technical Drawing

  1974 — 1982

• The Center for Professional Advancement

  Certificate, Good Clinical Practices

  1998 — 1998

• Sponsored by the US Food And Drug Administration

  Certificate, Part 1a – Good Clinical Practice 101

  2011 — 2011

• Baruch College

  Certificate, Certificate in International Business Management and Purchasing

  1994 — 1994

Skills

• Validation
• Life Sciences
• Clinical Development
• Quality Assurance
• Regulatory Submissions
• Sharepoint
• U.s. Food and Drug Administration (Fda)
• Clinical Data Management
• 21 Cfr Part 11
• Good Clinical Practice (Gcp)
• Access Database
• CRO Management
• Gcp
• Powerpoint
• Microsoft Excel
• Software Documentation
• Edc
• Ctms
• Visio
• Standard Operating Procedure (Sop)
• U.s. Title 21 Cfr Part 11 Regulation
• Isi Toolbox
• CRO
• Ich-Gcp
• Document Management
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Clinical Research
• Regulatory Affairs
• Lifesciences
• Data Management
• Pharmaceutical Industry
• Sop
• Fda
• Tmf
• Clinical Trials