Overview
In this role you will serve as the single point of contact for investigative sites and cross-functional teams to ensure compliant site activation and regulatory documentation. You will manage start-up activities, maintain regulatory and project documents, and monitor timelines to support study progress. You’ll provide local expertise during planning and troubleshooting, while upholding SOPs, GCP/ICH guidelines, and company standards. This is a home-based position in which you’ll enable timely site activation and quality deliverables, contributing to a compliant, efficient clinical trial process.
Verantwortungsbereiche
- Act as SPOC for assigned studies, coordinating with SAM, PM team, and other departments
- Perform start-up and site activation activities per regulations and SOPs
- Distribute regulatory documents to sites and internal teams
- Prepare and review site regulatory documents for completeness and accuracy
- Maintain internal systems and tracking tools with project data
- Provide feedback on site performance metrics and timelines
- Ensure monitoring measures and contingency plans are in place
- Track and coordinate regulatory, ethics, ICF, and IP release documents per timelines
- Offer local regulatory expertise during planning and execution
- Perform QA/QC of site-provided documents
- May interact with sponsors on specific initiatives
Zentrale Anforderungen
- Bachelor’s Degree in life sciences or related field; 3 years’ clinical research or relevant experience; or equivalent combination
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Understanding of regulatory requirements including local regulations, SOPs and corporate standards
- Knowledge of regulated clinical trial environment and drug development process
- Strong communication skills
- Attention to detail
- Cross-functional collaboration
- GCP/ICH knowledge
- Regulatory submission and documentation
- Site activation and start-up processes
Regulatory and Start Up Specialist - Austria Arbeitgeber: IQVIA
IQVIA ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in New Orleans die Möglichkeit bietet, in einem dynamischen und unterstützenden Umfeld zu arbeiten. Mit einem starken Fokus auf berufliche Weiterentwicklung und einem flexiblen Arbeitsmodell fördert das Unternehmen eine positive Work-Life-Balance und ermöglicht es den Flex Nurse Educators, Patienten durch innovative Bildungsansätze zu unterstützen. Die Unternehmenskultur legt Wert auf Teamarbeit und Vielfalt, was IQVIA zu einem attraktiven Arbeitsplatz für engagierte Fachkräfte macht.
