Regulatory Submissions (Study Start-Up) Manager

Job SummaryWe are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia.
ResponsibilitiesEfficiently manage and successfully execute all aspects of global start-up;Perform quality checks on submission documents and site essential documents;Prepare and approve informed consent forms;Review pertinent regulations to develop proactive solutions to start-up issues and challenges;Present during bid defenses, general capabilities meetings, and audits.QualificationsMore than 5 years of experience in clinical research, preferably with a CRO.
Experience may include CRA or project management experience;Regional experience will be highly advantageous;Strong oral and written communication skills.Travel: Minimal

#J-18808-Ljbffr