Reg & Start Up Spec 2

Job Overview

Perform and lead Site Activation and Start-Up activities at country level ensuring timely site readiness in compliance with applicable local regulations ICH-GCP SOPs project requirements and contractual guidelines. Acts as a key operational and regulatory partner to project teams providing local expertise and ownership of timelines quality and deliverables. Also include site maintenance activities.

Essential Functions

• Serve as Single Point of Contact (SPOC) for assigned studies acting as the main liaison between investigative sites Site Activation Managers (SAMs) Project Management and cross-functional teams.

• Independently manage start-up and site activation activities in compliance with regulations SOPs and work instructions ensuring delivery according to agreed timelines.

• Prepare review and quality-control site regulatory and start-up documentation ensuring completeness accuracy and readiness for submission and site activation.

• Track follow up and proactively manage the progress approval and execution of regulatory ethics ICF Investigator Pack (IP) and site activation documents.

• Maintain accurate and timely updates in internal systems databases and tracking tools.

• Review site performance metrics identify risks and propose mitigation or contingency actions as needed.

• Support project planning and timelines providing local regulatory and operational expertise to global and regional project teams.

• Ensure effective communication and timely notifications to project teams regarding site readiness and document completion.

• Perform quality control of documents provided by sites and escalate issues when required.

• May interact directly with sponsors or external stakeholders on specific start-up or regulatory initiatives.

Qualifications

• Bachelors Degree preferred (life sciences or related field);

• Minimum 3 years of clinical research experience with strong hands-on exposure to Site Activation / Start-Up activities supporting sites in Argentina.

• Prior experience in a senior lead or coordination role is highly valued.

• In-depth knowledge of GCP/ICH guidelines local regulatory requirements SOPs and corporate standards.

• Strong understanding of the clinical trial environment and drug development process.

• Proven ability to manage multiple studies and sites simultaneously with a high level of independence.

• Strong communication negotiation and organizational skills with ability to challenge timelines and escalate risks appropriately.

• Ability to establish and maintain effective working relationships with internal teams sites and clients.

• Solid conversational English level.

• Preferrably based in Buenos Aires GBA CABA.

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

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.