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[at]idctechnologies.com
URL : WWW.idctechnologies.com
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