Clinical Trial Startup Manager

hace 2 meses


Ciudad de México, Ciudad de México PSI A tiempo completo

Job Opportunity

PSI is seeking a highly skilled professional to support the startup process of clinical trials in Mexico. As a key member of our team, you will play a crucial role in ensuring the smooth and timely activation of clinical trial sites.

Key Responsibilities

  • Coordinate the activation of clinical trial sites, overseeing critical processes and ensuring compliance with regulatory requirements.
  • Communicate effectively with project teams, investigative sites, review bodies, vendors, and clients to facilitate the startup process.
  • Support site identification and selection, ensuring that only suitable sites are selected for clinical trials.
  • Collect, review, and submit documents for ethics and regulatory review and approval, ensuring timely submission and minimal delays.
  • Prepare packages of site documents for drug release to clinical sites, ensuring accuracy and completeness.
  • Develop and negotiate site contracts and budgets, ensuring fair and reasonable terms.
  • Monitor startup metrics and timelines, identifying areas for improvement and implementing process enhancements.

Requirements

  • College/University degree or equivalent combination of education, training, and experience.
  • Minimum 3 years of industry experience in clinical research, with practical startup experience in the Country/Region.
  • Excellent knowledge of ICH GCP, local laws, and applicable regulations in the region.
  • Full working proficiency in English and Spanish.
  • Strong communication and organizational skills, with ability to negotiate and build relationships at all levels.
  • Experience in mentoring and leadership is preferred.


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