Direct Client Opening - TMF Business Analyst - Groton, CT

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 : ashish.gupta@idctechnologies.com

URL : WWW.idctechnologies.com

 

 

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