Clinical Research Study Start-Up Project Manager
Medpace Holdings, Inc.
Brazil, Sao Paulo
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Study Start-Up Manager (Regulatory Submissions Manager) to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position plays a key role in the clinical trial management process at Medpace. 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.
- 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.
- At least 4 years of experience in clincial research, preferably with a CRO, including at least 2 years of experience leading regulatory/start-up project teams;
- Knowledge and experience of Clinical Trial Applications within Latam;
- Strong oral and written communication skills;
- Team oriented approach and strong leadership skills; and
- Fluency in English.
We kindly ask to send applications in English.