Overview
In this role you lead the operational delivery of strategic clinical studies at the country level, aligning with ICH/GCP and local requirements. You work closely with global and local teams to meet recruitment and sponsor deliverables while managing relationships with investigators and external partners. You drive feasibility assessments, site relationships, and study startup activities to ensure timely, high-quality clinical trial execution. This position offers impact across therapeutic areas within a global sponsor context at IQVIA.
Verantwortungsbereiche
- Oversee local CRO activities as main point of contact for strategic studies to meet country objectives
- Coordinate with Clinical Study Teams and Global Monitoring to hit milestones and ensure quality
- Ensure core document accuracy for local EC submissions via Study Start-Up collaboration
- Lead country feasibilities and collect key market/regulatory information for study planning
- Develop professional relationships with investigators and Key Opinion Leaders
- Support Global Monitoring in co-monitoring and CRA assessment visits when needed
- Act as Site Relationship Partner to maintain site performance across the study lifecycle
- Comply with SOPs, ICH/GCP, FDA regulations, and local regulatory bodies
- Collaborate with Medical Affairs, QA, Global Monitoring, and regulatory teams as needed
- Ensure consistency and accuracy of core documents for local submissions and translations
Zentrale Anforderungen
- At least 5 years’ clinical research experience (CRA/Lead CRA/Project Manager)
- Bachelor or higher degree in life sciences, nursing, or medical background preferred
- Knowledge of clinical trial methodology, GCP, SOPs, and country-specific regulatory requirements
- Strong problem-solving ability and ability to prioritize independently
- Excellent organizational and time management skills
- Ability to build and maintain relationships with internal and external stakeholders
- Willingness for domestic and international travel (~20% of the week)
- English CV required for application
- problem-solving orientation
- independence and initiative
- strong interpersonal skills
- clinical trial monitoring
- GCP and regulatory knowledge
- SOP adherence
Country Clinical Research Lead 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.