*Hi Friends,*

*Hope you are doing great.*

*We have very urgent opening for the following positions and can setup
interview immediately.  If you have any suitable profile please send the
resume in word format to * *ryan.fran...@itbtalent.com
<ryan.fran...@itbtalent.com>*
*, you can also reach me at 609-423-4877. *







*Job Title : Business Analyst with Trial Master File (TMF)Location :
Groton, CTDuration : Long TermMust Have Trial Master File (TMF)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.


* Required Skills:-*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
*Note: Please reply me on my official E-Mail ID : **ryan.fran...@itbtalent.com
<neil.kha...@itbtalent.com>*


*Thanks*
*Ryan Francis *| *Senior IT Recruiter*
*ITBrainiac Inc*
D: 609-423-4877
Email: ryan.fran...@itbtalent.com

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