Clinical Study Operations Specialist

AstraZeneca; Ciudad de México; Presencial; MXN 300.000 - 520.000; Jornada completa

Descripción de la vacante

AstraZeneca in Mexico City is seeking a Clinical Study Administrator to assist in coordinating and administering study activities from start-up through close-out, ensuring quality and timely delivery within budget.

You will interact with investigators, CRAs and LSAD, maintain the local eTMF and ISF, support regulatory submissions and archiving, and help prepare study documents and materials for audits and inspections.

Formación

• Must have administrative experience in medical or life sciences settings.
• Strong organizational and administrative skills are required.
• Good knowledge of spoken and written English.
• Proficiency with clinical trial systems and document management tools.

Responsabilidades

• Assist in coordination and administration of clinical studies from start-up to close-out.
• Support submission of documents to EC/IRB and regulatory authorities as needed.
• Maintain local eTMF and ISF in line with ICH-GCP and local requirements.
• Coordinate communication with Investigators, CRAs, and LSAD; manage study materials and documentation.
• Prepare and distribute study documents, presentations, and meeting materials; assist with translations and archiving.

Conocimientos

Administrative experience

Organizational skills

English proficiency

Attention to detail

Educación

Scientific degree

Herramientas

Veeva Clinical Vault

SAP S/4HANA

Coupa

Descripción del empleo

AstraZeneca in Mexico City is seeking a Clinical Study Administrator to assist in coordinating and administering study activities from start-up through close-out, ensuring quality and timely delivery within budget.

You will interact with investigators, CRAs and LSAD, maintain the local eTMF and ISF, support regulatory submissions and archiving, and help prepare study documents and materials for audits and inspections.