Site Activation Specialist, ICF Lead

IQVIA LLC; Buenos Aires; Remote; ARS 91,219,000 - 136,828,000; Full time

Job summary

IQVIA LLC is seeking a Site Activation Specialist, ICF Lead to operate in LATAM on a remote basis. You will function as a senior individual contributor, coordinating site activation activities and ensuring compliance with local and international regulations, SOPs, and budgets.

In this role you will manage feasibility, site identification, regulatory submissions, and key start-up deliverables, collaborating with SAMs, PM teams, and investigative sites to drive on-time study initiation and data

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum of 3 years of clinical research or relevant experience.
• Strong understanding of country-specific regulatory requirements.
• Ability to manage multiple priorities and work cross-functionally.
• Excellent communication and problem-solving mindset.

Responsibilities

• Act as the Single Point of Contact (SPOC) for assigned studies and collaborate with sites, SAMs, PM teams, and internal stakeholders.
• Ensure compliance with local regulations, SOPs, WIs, quality standards, and project timelines.
• Perform feasibility assessments, site identification, start-up, and activation activities per regulatory requirements.
• Prepare, review, and distribute site documentation with completeness and accuracy.
• Maintain accurate information in internal systems and tracking tools.
• Review site performance metrics and provide insights to management.
• Align project plans and timelines and implement monitoring and contingency measures.
• Communicate milestone completions to project team members.
• Review and track study documents (CDAs, SIFs, regulatory submissions, ICFs, IPs, releases).
• Provide local regulatory and operational expertise to SAMs and project teams.
• Perform quality control reviews of documents from investigative sites.

Skills

Strong communication

Attention to detail

Problem solving

Multi-priority management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Job description

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.

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.