Clinical Trial Manager, Regulatory Expert

Syneos Health

México

Presencial

MXN 600.000 - 900.000

Jornada completa

Hace 5 días
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Descripción de la vacante

Syneos Health is seeking a Clinical Trial Manager with regulatory experience to lead cross-site monitoring and regulatory documentation in Mexico. You will ensure protocol compliance and maintain data integrity across trial activities.

You will coordinate with site staff and sponsor teams, manage timelines and quality, and help ensure regulatory submissions and approvals are completed in a timely manner. The role emphasizes strong communication, problem-solving, and regulatory knowledge to drive

Responsabilidades

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Descripción del empleo

Syneos Health is seeking a Clinical Trial Manager with regulatory experience to lead cross-site monitoring and regulatory documentation in Mexico. You will ensure protocol compliance and maintain data integrity across trial activities.

You will coordinate with site staff and sponsor teams, manage timelines and quality, and help ensure regulatory submissions and approvals are completed in a timely manner. The role emphasizes strong communication, problem-solving, and regulatory knowledge to drive

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