avatar for Shah Ashraf

Shah Ashraf

Sr TMF Quality Specialist, Life Sciences Solutions
Greater New York City Area
I am a Certified Clinical Research Auditor.
My Title is Sc TMF Quality Specialist at TRANSPERFECT Life Science Solution.
In my present role, I am leading a e-TMF Quality group, performing internal and external TMF Audits and looking over the Quality of the assigned TMF.
My Background:-
 I have 15 + Years experience in handling/reviewing Clinical and Regulatory documentation
 My previous experience , Started my carrier as a Certified Lab Assistance . Then moved on to BOC/Ohmeda/ Baxter/Celgene/ and now proud to be in TransPerfect.
 In Baxter worked as a Sc Clinical Research Document Specialist plus also worked in Regulatory Submission Department as a Team Lead in CAPA resolution.
 In Celgene worked as Global Regulatory Document Archivist
 My experience includes the TMF Reference Model Subject Matter Expert, eTMF management, electronic document management, quality control processes and implementation
 I am also a Project Member from last 6 years of the TMF Reference Model Stirring Committee and
 Actively participating in various TMF Reference Model Groups
• Team Lead in 2016 Survey Team
• Present involved in Sub-Artifact Research and decision making
• eTMF Quality
• Site Management Zone
• Survey Team
Love to talk about any topics related to TMF Quality.