Regulatory Submissions (Study Start-up) Manager

We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia.

• Efficiently 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; and
• Present during bid defenses, general capabilities meetings, and audits.

• More 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