Yogita Nanaware

Eclinical Systems Analyst @TransPerfect

Pune, IN

Work with Study Owners with all start up, maintenance and close out activities in regards to the TMF• eTMF ongoing user management• May be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMF• Create and complete TMF quality reviews to ensure document content and metadata application are accurate and to ensure documentation is present/complete in the TMF• Communicate all systematic filing issues to the manager for further training evaluation• Periodic quality reviews for each active study site for all regulatory documents, including: Institutional Review Board (IRB) Renewal, IRB Protocol Approval, Informed Consent Review, Signature of Co-Investigator, IRB Membership list, Lab Normal, College of American Pathologists (CAP), Clinical Laboratory Improvements Amendments (CLIA), 1572 Form, Agreements, Principal Investigator (PI) CVs• Draft, review and approve TMF Quality plans and reports and reconciliation of findings• Assist in regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines• Identify and report to Study Owner, Clinical Document Lead, Project Manager, Client and, or Manager on TMF trending issues/concerns, determining resolutions and course of actions• Provide support on metrics and report preparation for TMF Key Performance Indicators (KPIs)- completeness, quality and timeliness• Storyboard support and maintenance to assist with inspection readiness• Clinical Trial Management System (CTMS) data entry and analysis on behalf of CTMS and enterprise clients• Meeting minutes and agendas• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor.

Pad Dr.D.Y. Patil ACS college, Pimpri Pune

Bachelor's of microbiology

Ajeenkya D Y Patil University

Masters in clinical research