Site Activation Specialist – Informed Consent Forms Lead

Site Activation Specialist, ICF Lead
Location: LATAM
Work Model: Homebased

Job Overview

The Site Activation Specialist, ICF Lead performs country-level Site Activation (SA) activities in compliance with applicable local and international regulations, IQVIA Standard Operating Procedures (SOPs), project requirements, and contractual or budgetary guidelines.

This role is a senior individual contributor position, operating under moderate supervision, with responsibility for managing key start-up deliverables and providing local and regional expertise. The role also contributes to continuous improvement by making recommendations to enhance processes, systems, and operational effectiveness within Site Activation.

Essential Functions

• Under general supervision, act as the Single Point of Contact (SPOC) for assigned studies, collaborating with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other internal stakeholders
• Ensure compliance with local regulations, SOPs, Work Instructions (WIs), quality standards, and agreed project timelines
• Perform feasibility assessments, site identification, study start-up, and site activation activities in line with regional regulatory requirements
• Prepare, review, and distribute site documentation, ensuring completeness, accuracy, and timeliness
• Maintain accurate and up-to-date information in internal systems, databases, and tracking tools
• Review site performance metrics and provide insights and feedback to management
• Review, establish, and align on project plans and timelines, ensuring monitoring measures and contingency plans are implemented when needed
• Communicate completion of feasibility, site identification, regulatory, and contractual milestones to relevant project team members
• Review, track, and follow up on the progress, approval, and execution of study documents, including:
  • Confidential Disclosure Agreements (CDAs)
  • Site Information Forms (SIFs)
  • Regulatory and ethics submissions
  • Informed Consent Forms (ICFs)
  • Investigator Packs (IPs) and IP release documentation
• Provide local regulatory and operational expertise to SAMs and project teams during start-up and throughout study execution
• Perform quality control reviews of documentation received from investigative sites
• Maintain limited and appropriate direct sponsor contact for specific initiatives, as required

Qualifications

• Bachelor’s degree in Life Sciences or a related field (required)
• Minimum of 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience
• Strong understanding of country-specific regulatory requirements within one or more of the listed locations
• Demonstrated ability to manage multiple priorities, meet deadlines, and work cross-functionally
• Strong communication skills, attention to detail, and problem-solving mindset

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.