Hello,

Hope you are doing great.

Please review the requirement and if you find it matching your profile then
send me your updated resume *ASAP/IMMEDIATE*



*Job Title: TMF Business Analyst*

*Location: Groton, CT*

*Duration: 1-3 Years*



Job Description:

The TMF Business Analyst will be responsible for, but not limited to the
following:

·         Perform the role of an IT business analyst with strong
understanding of TMF application & business process.

·         Draft requirements for existing Trial Master File application in
Clinical Trials arena.

·         Interact with business stakeholders to assist business in
monitoring the quality and completeness state of assigned study TMFs;

·         Coordinate with business support team & IT support teams for any
issues with the TMF application

·         Define, elaborate and track requirements for new features or
enhancements of TMF application as part of software development

·         Ability to work with IT support and business support teams
involved in managing the TMF application. This includes leadership of
cross-functional TMF business user/IT / meetings in the role of a TMF
business analyst.



Skillsets:

IT Business analysis with good understanding of following functional
processes of Trial Master File:

·         Clinical Trial Master File application business processes

·         TMF Workflow, processes related risk/ issues /challenges

·         Document Management System & data dictionaries

·         Records retention for paper documentation

·         Regulatory Compliance and Record Retention policies

·         Monitoring metrics & overall TMF process completeness

·         Familiar with ICH Good Clinical Practices, FDA Good Clinical
Practices and other appropriate regulations



Regards

Ashish Gupta

1351 McCarthy Boulevard, Suit 116, Milpitas, CA, USA, 95035

*Phone* : 408-457-9381 Ext 4103

*Yahoo, Gtalk* : ashish.recruiter12

*Email* : [email protected]

*URL* : WWW.idctechnologies.com

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