Remote Start-Up & Regulatory Specialist I

IQVIA; México; A distancia; MXN 580.000 - 870.000; Jornada completa

Descripción de la vacante

IQVIA Regulatory & Start Up Specialist 1 in Mexico is a full home-based role, driving start-up and maintenance activities for assigned studies and sites in the country. You will serve as SPOC for sites, SAMs, and project teams, ensuring SOPs and timelines are met.

Responsibilities include preparing regulatory documents, tracking project data, coordinating timelines, and providing local expertise during planning. Fluency in English and strong analytical and interpersonal skills are required.

Formación

• Bachelor Degree in life sciences.
• +1 years of clinical research experience and study start up management experience.
• Fluent English: written and oral communication skills.
• Good analytical and critical thinking skills and ability to evaluate complex issues.
• Good interpersonal skills with the ability to build trust and adapt to changing requirements.
• Demonstration of successful execution, preferably in start up, with multiple priorities.

Responsabilidades

• Serve as SPOC in assigned studies for sites, SAM, and project teams; ensure SOP/WI adherence.
• Perform start up and site activation activities per regulations and WIs; share documents.
• Prepare site regulatory documents, review for completeness and accuracy.
• Ensure accurate maintenance of internal systems and trackers with project data.
• Review site performance metrics and provide timely feedback to management.
• Plan project timelines; implement contingency measures and monitor progress.
• Inform team upon completion of regulatory and contractual documents for sites.
• Coordinate approval, execution, and tracking of regulatory/ICF/IP release documents.

Conocimientos

Fluent English

Analytical skills

Interpersonal skills

Multi-priority management

Regulatory knowledge

Educación

Bachelor's degree in life sciences

Descripción del empleo

IQVIA Regulatory & Start Up Specialist 1 in Mexico is a full home-based role, driving start-up and maintenance activities for assigned studies and sites in the country. You will serve as SPOC for sites, SAMs, and project teams, ensuring SOPs and timelines are met.

Responsibilities include preparing regulatory documents, tracking project data, coordinating timelines, and providing local expertise during planning. Fluency in English and strong analytical and interpersonal skills are required.