Pleasure mailing you. I came across your profile in job portal and wanted
to touch base with your regarding one of our client opportunity. Please go
through the below requirement and let me know if you are comfortable for
the position.

Please send me your updated resume along with the best rate cap, visa
status and availability. An early response is really appreciated

Job Role: Trial Master File (TMF) IT Business Analyst

Location: Groton, CT,USA

Duration: Long Term (Minimum of  1 yr and will be extended to 3 yrs)

*Job Description:*

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

·         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.


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

Thanks & Regards,


Prosercorp d.b.a Tekskills Inc

ISO 9001: 2008 Certified Company

Phone:732-640-2152 |Fax: 888-543-5125

*bharad...@tekskillsinc.com* <bharad...@tekskillsinc.com>

200, MetroplexDrive, Suite414, Edison, NJ – 08817

www.*tekskillsinc*.com <http://www.tekskillsinc.com/>

*Gmail: **recrui...@gmail.com* <recrui...@gmail.com>*  / Gtalk: recrui1er*

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