Regulatory Operations Specialist
5 days ago
This Site Activation Manager position plays a critical role in our clinical Functional Service Provider (cFSP) team at IQVIA Argentina. As part of this team, you will direct and manage site activation, maintenance, and regulatory activities for assigned projects, ensuring compliance with project timelines and regulatory requirements.
Key Responsibilities:- Project Management: Direct and manage the delivery of site activation, maintenance, and regulatory activities for assigned projects in accordance with the agreed scope of work and project plan.
- Team Collaboration: Foster collaboration across regulatory and site activation teams, including regions and countries, to successfully deliver project scope and achieve business objectives.
- Documentation and Reporting: Create and review technical and administrative documentation to support business development and study initiation, while ensuring compliance with regulatory requirements.
- Regulatory Strategy and Planning: Determine regulatory strategy and expectations for submissions and authorizations, identifying regulatory complexity and challenges to support bid process and site activation plan execution.
- Regulatory Intelligence and Support: Assess and review the regulatory landscape, contributing to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and company-wide initiatives.
- Bachelor's Degree: Life sciences or related field.
- Regional Experience: Associate Site Activation Manager: 3-5 years of regional experience in clinical research environment; Site Activation Manager: over 5 years of regional experience in clinical research environment.
- Leadership and Organizational Skills: Proven ability to work through others to deliver results on complex projects, demonstrating good leadership skills, ability to motivate, coach, and mentor.
- Regulatory Knowledge: Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process, applying Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. Our goal is to improve patient outcomes and population health worldwide by accelerating medical treatment development and commercialization.
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Financial Operations Specialist
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Regulatory Reporting Specialist
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