Regulatory & Start-Up Specialist I — Remote (Chile)

IQVIA

Santiago

A distancia

CLP 53.450.000 - 72.886.000

Jornada completa

Hace 11 días
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Descripción de la vacante

IQVIA seeks a Regulatory & Start Up Specialist 1, cFSP - Chile support, a full home-based role. The incumbent will act as SPOC for studies, sites, and teams, ensuring SOP adherence and on-time delivery of start-up activities.

The role requires a life sciences degree, 1+ years of clinical research/start-up experience, and fluent English. Strong analytical, interpersonal, and regulatory skills are essential to success.

Formación

  • Bachelor degree in life sciences or related field.
  • Fluent written and spoken English.
  • Analytical thinking and ability to evaluate complex issues.
  • Strong interpersonal communication and collaboration skills.
  • Experience in start-up and regulatory activities is a plus.

Responsabilidades

  • Serve as SPOC for studies, sites, SAM, and project teams while ensuring SOP/WI compliance.
  • Execute start up and site activation activities per regulations and procedures.
  • Prepare and review site regulatory documents for completeness and accuracy.
  • Maintain internal systems and tracking tools with project information.
  • Provide feedback on site performance metrics to management.
  • Plan project timelines, monitor progress, and implement contingencies.
  • Communicate regulatory/document handover status to team members.
  • Provide local regulatory expertise during project planning.
  • Perform quality control of documents provided by sites.

Conocimientos

English proficiency
Analytical thinking
Interpersonal skills
Regulatory knowledge (start-up)

Educación

Bachelor's degree in life sciences

Descripción del empleo

IQVIA seeks a Regulatory & Start Up Specialist 1, cFSP - Chile support, a full home-based role. The incumbent will act as SPOC for studies, sites, and teams, ensuring SOP adherence and on-time delivery of start-up activities.

The role requires a life sciences degree, 1+ years of clinical research/start-up experience, and fluent English. Strong analytical, interpersonal, and regulatory skills are essential to success.

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