Regulatory Submissions (Study Start-up) Manager

Job Summary

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

Responsibilities

1. Efficiently manage and successfully execute all aspects of global start-up;
2. Perform quality checks on submission documents and site essential documents;
3. Prepare and approve informed consent forms;
4. Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
5. Present during bid defenses, general capabilities meetings, and audits.

Qualifications

1. More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
2. Regional experience will be highly advantageous;
3. Strong oral and written communication skills.

Travel: Minimal