Site Activation Specialist

IQVIA

Buenos Aires

Remote

ARS 68,155,000 - 98,446,000

Full time

5 days ago
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Job summary

IQVIA is seeking a Site Activation Specialist for full remote work in Argentina. You will manage SA activities countrywide, coordinating with the SAM and PM teams, ensuring regulatory and contractual documents are completed on schedule.

Your role includes start-up, site activation, and maintenance activities, preparing regulatory materials, and ensuring data accuracy across systems. Strong English, communication, and organizational skills are essential.

Qualifications

  • Bachelor's degree required.
  • 2+ years of clinical research experience; candidate in this field is a plus.
  • Experience in regulatory activities in Argentina, incl. ethics committees and ANMAT (SSU and maintenance phases).
  • Strong English language proficiency.
  • Excellent communication and interpersonal skills.
  • Excellent organization and prioritization skills.

Responsibilities

  • Serve as Single Point of Contact (SPOC) for investigative sites, SAM, PM team, and other departments.
  • Perform startup and site activation activities per regulations; distribute documents to sites and internal team.
  • Prepare site regulatory documents and review for completeness and accuracy.
  • Maintain internal systems, databases, and tracking tools with project information.
  • Review site performance metrics and provide feedback to management.
  • Plan project timelines, set monitoring measures, and implement contingency plans.
  • Inform team of regulatory and contractual document completion for sites.
  • Track progress and approvals of regulatory, ethics, ICF, and IP release documents as per timelines.
  • Provide local expertise during project planning.
  • Quality control of documents provided by sites.
  • May have direct sponsor contact on specific initiatives.

Skills

Communication
English
Organization

Education

Bachelor's degree

Job description

Site Activation Specialist Full Home-based - Argentina
Job Overview

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
  • 2+ years of clinical research experience, clinical trial assistant experience is a plus.
  • Experience in clinical research regulatory activities in Argentina, including presentations to ethics committees and ANMAT (SSU and maintenance phases)
  • Good command of English Language
  • Excellent communication and interpersonal skills
  • Excellent organization ad priorization skills

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.

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