Direct Client-Urgent Need :: Business Analyst with Clinical Trial Exp :: Groton, CT

Dear Vendor Partners,

 

Please send Resume to    ankit.kumar@idctechnologies.com

 

Please share profiles with specific TMF experience.

 

There is an urgent requirement with one of our Pharma clients for a TMF Business Analyst and hence request you to fetch some profiles at the earliest.

 

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

 

Location:  Groton, CT,USA

 

Experience (yrs) : 6-8 Yrs

 

Term:  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 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

 

Best Regards

Ankit kumar Sagwal

IDC Technologies Inc.

E-mail: ankit.kumar@idctechnologies.com

Phone: 408-457-9381 Ext. 4030

GTalk: ankit121.rgtalent

Ymgr: ankit_sagwal

 

 

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