Study Start Up Manager
4 semanas atrás
Medpace, Inc. is seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo. This role plays a critical part in the clinical trial management process, requiring a strong understanding of regulatory requirements and a proactive approach to issue resolution.
Responsibilities- Manage and execute global start-up activities efficiently, ensuring timely and successful project delivery.
- Perform quality checks on submission documents and site essential documents to ensure compliance with regulatory standards.
- Prepare and approve informed consent forms, ensuring accuracy and adherence to regulatory guidelines.
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges, driving process improvements and efficiency gains.
- Present during bid defenses, general capabilities meetings, and audits, effectively communicating regulatory knowledge and expertise.
- At least 4 years of experience in regulatory submissions/start-up management, with a proven track record of leading regulatory/start-up project teams.
- Knowledge and experience of Clinical Trial Applications within Latam, with a strong understanding of regional regulatory requirements.
- Strong oral and written communication skills, with the ability to effectively communicate complex regulatory information to stakeholders.
- Team-oriented approach and strong leadership skills, with the ability to motivate and guide team members to achieve project goals.
- Willingness to work in an office-based model, with flexibility to adapt to changing project requirements.
- Fluency in English and local language, with the ability to communicate effectively with global stakeholders.
A Medpace team member will review your qualifications and, if interested, contact you with details for next steps.
Medpace, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.
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