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Regulatory Submissions

3 weeks ago

Singapore Medpace Full time

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