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Study Start Up Manager

2 meses atrás

São Paulo, São Paulo, Brasil Medpace, Inc. Tempo inteiro
Job Summary

Medpace, Inc. is seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in a full-time, office-based role. This position plays a critical role in the clinical trial management process, requiring expertise in regulatory submissions and start-up management.

Key Responsibilities

The successful candidate will be responsible for:

  • Efficiently managing and executing all aspects of global start-up, ensuring timely and accurate submissions;
  • Performing quality checks on submission documents and site essential documents to maintain regulatory compliance;
  • Preparing and approving informed consent forms, ensuring adherence to regulatory requirements;
  • Reviewing pertinent regulations to develop proactive solutions to start-up issues and challenges;
  • Presenting during bid defenses, general capabilities meetings, and audits to demonstrate expertise and build relationships.
Requirements

To be successful in this role, the candidate will require:

  • At least 4 years of experience in regulatory submissions and 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 regulatory requirements;
  • Strong oral and written communication skills, with the ability to effectively present to stakeholders;
  • Team-oriented approach and strong leadership skills, with the ability to motivate and guide team members;
  • Willingness to work in an office-based model, with flexibility to adapt to changing priorities;
  • Fluency in English and local language, with the ability to communicate effectively with global teams.
What to Expect

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Medpace, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.