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Regulatory Submissions Manager

Medpace Holdings, Inc.

Spain, Madrid

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

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

Qualifications

At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;Knowledge and experience of Clinical Trial Applications within Europe;

Bachelor's degree or Master's degree within Life Sciences;Strong oral and written communication skills;Team oriented approach and strong leadership skills; andFluency in English.

Job posted: 2023-03-02

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