Site Activation Specialist II – Global Start-Up & Submissions

Syneos Health; México; Presencial; MXN 360.000 - 540.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Site Activation Specialist II to manage country-level start-up activities, ensure timely submissions, and maintain compliance with SOPs and regulatory requirements.

You will coordinate with country start-up teams, prepare EC/RA submissions, manage essential documents, and support continuous quality improvement across SSU components from country to site. This role requires strong organizational skills and collaboration with PM/SAM and regulatory authorities.

Formación

• Experience with country-level regulatory submissions and site start-up processes.
• Knowledge of SOPs and work instructions in clinical trials.
• Strong documentation management and QA mindset.

Responsabilidades

• Responsible for country-level quality deliverables and adherence to project requirements and country rules.
• Monitor submission timelines and maintain real-time tracking for SSU milestones.
• Review SOPs/WIs and keep training records updated; ensure timesheet compliance.
• Support continuous improvement of SSU quality across country-level components.
• Prepare and submit local regulatory submissions (EC/RA) as required.

Conocimientos

Regulatory knowledge

SOP compliance

Documentation management

Country start-up coordination

Descripción del empleo

Syneos Health is seeking a Site Activation Specialist II to manage country-level start-up activities, ensure timely submissions, and maintain compliance with SOPs and regulatory requirements.

You will coordinate with country start-up teams, prepare EC/RA submissions, manage essential documents, and support continuous quality improvement across SSU components from country to site. This role requires strong organizational skills and collaboration with PM/SAM and regulatory authorities.