Reg & Start Up Spec 2

Description

Summary: Lead and perform site activation and start-up activities at the country level, ensuring timely site readiness in compliance with regulations and project requirements. Highlights: 1. Serve as Single Point of Contact (SPOC) for assigned studies 2. Independently manage start-up and site activation activities 3. Provide local regulatory and operational expertise to project teams Buenos Aires, Argentina \| Full time \| Home\-based \| R1538893 **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*** **Bachelor’s 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 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.