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