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 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 Thanks & Regards, *Bharadwaj* 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* -- You received this message because you are subscribed to the Google Groups "REQSRESUMES" group. To unsubscribe from this group and stop receiving emails from it, send an email to reqsresumes+unsubscr...@googlegroups.com. To post to this group, send email to email@example.com. Visit this group at http://groups.google.com/group/reqsresumes. For more options, visit https://groups.google.com/d/optout.