FSP - Sr. Regulatory & Start Up Specialist

IQVIA; Argentina; A distancia; ARS 1.500.000 - 2.000.000; Jornada completa

Descripción de la vacante

A global clinical research provider is seeking a Sr. Regulatory & Start Up Specialist in Argentina. The role involves managing site activation tasks, ensuring adherence to regulations, and preparing regulatory documents. Candidates should have a Bachelor's degree in life sciences and over 3 years of experience in clinical research. Fluent English and independence are essential. This position operates in a hybrid model.

Formación

• 3+ years of clinical research experience within regulatory area in Argentina.
• Experience with local submissions and ICF customization.
• Conduct presentations to ethics committee & ANMAT.

Responsabilidades

• Serve as Single Point of Contact (SPOC) for investigative sites.
• Perform site activation activities according to regulations and SOPs.
• Prepare and review site regulatory documents for completeness.

Conocimientos

Fluent English

Independent work

Clinical research experience

Educación

Bachelor's Degree in life sciences

Descripción del empleo

Job Overview

The Sr. Regulatory & Start Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's Degree in life sciences.
• +3 years of clinical research experience within regulatory area in Argentina:
• • Local submissions
  • ICF customization
  • Presentations to ethics committee & ANMAT.

• Fluent English: written and oral communication skills

• Ability to work independently

#LI-NRJ #LI-Remote

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