
Study Start-up Submissions Expert
3 hours ago
We are seeking a Study Start-up Submissions Specialist 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.
The ideal candidate will have:
- 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.
To succeed in this role, the candidate will need:
- Experience managing and executing global start-up processes;
- Strong analytical and problem-solving skills;
- Ability to work effectively in a team environment;
- Excellent communication and interpersonal skills.
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