Sr. Site Activation Coordinator (North America team)

IQVIA; Buenos Aires; Presencial; ARS 600.000 - 1.200.000; Jornada completa

Descripción de la vacante

IQVIA in Argentina is seeking a Site Activation Associate to support feasibility, site activation and maintenance activities at a country level, ensuring regulatory and SOP compliance. You will collaborate with the SAM, PM team, and other departments to prepare and review documentation for investigative sites.

The ideal candidate has a life sciences degree, at least two years in a clinical research setting, and advanced English to liaise with North American sites.

Formación

• Bachelor's degree in Life science or related field.
• With 2 years’ experience in a clinical research environment, with previous experience in regulatory or contract negotiation.
• Advanced level of English is mandatory, you'll be in touch with sites from North America.

Responsabilidades

• Perform feasibility, site activation and maintenance activities in assigned studies for investigative sites, according to regulations, SOPs and work instructions.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory, contractual and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Support updating and maintenance of internal systems, databases, tracking tools, timelines and project plans.
• Review and follow up on progress, approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, ICF and IP release documents.

Conocimientos

Regulatory knowledge

Contract negotiation

Documentation management

Site activation

Advanced English

Educación

Bachelor's degree Life science or related field

Descripción del empleo

Job Overview

Under general supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include feasibility or maintenance activities.

Essential Functions

• Under general supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory contractual. and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, the approval and execution of required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

Qualifications

• Bachelor's Degree Life science or related field.
• With 2 years’ experience in a clinical research environment, with previous experience in regulatory or contract negotiation.
• Advanced level of English is mandatory, you'll be in touch with sites from North America.

This is a home based role! IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.