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.francis@itbtalent.com, you can also reach me at 609-423-4877.
Job Title : Business Analyst with Trial Master File (TMF)
Location : Groton, CT
Duration : Long Term
Must 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
Thanks
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