• organizing kick-off meetings with the client co-ordination with the functional head.
• responsible for allocating the project/study to team members.
• responsible for review and internal approval of data management plan (dmp), case report form (crf), and edit check specification document (esd).
• responsible for review and internal approval of data entry guidelines, self-evident correction document (sec).
• internal approval of annotated crf (acrf) and functional design specification (fds) document.
• responsible for preparing and training the sop’s.
• responsible for approval of database screens, edit checks designed in database and dcf/query tracker.
• internal quality control for all data management documents like data management plan, annotated crf, functional design specification document, and edit check specification document.
• responsible for issuing the database test certificate.
• responsible for database lock and unlock procedures.
• responsible for exporting the data to sas team for analysis.
• responsible for review and approval of master data management file (mdmf).
• responsible for data management presentation in investigator meeting.
• providing inputs for proposal development in co-ordination with the function head.