Overview
As Site Management Lead, you will guide the Site Monitoring and Oversight for assigned trials, ensuring patient safety and data integrity through risk-based monitoring. You work with global trial teams to translate strategy into site-level execution, driving quality and timely delivery. You influence CRO performance and trial processes, shaping the monitoring approach across regions. This role offers meaningful impact by enhancing trial efficiency and patient outcomes within a leading global provider.
Verantwortungsbereiche
- Lead trial quality planning and risk monitoring/mitigation
- Develop and implement Site Monitoring & Oversight plans
- Deliver training to CT Managers and CRAs
- Author and review trial-level documents; act as SME on site management
- Represent monitoring strategy in global/regional/local meetings
- Incorporate patient/site feedback into design prioritizing safety
- Coordinate responses to questions from regulators and ethics committees
- Oversee CRO performance and adherence to ICH-GCP and SOPs
- Manage trial-level risk and issue resolution; maintain Risk-based Monitoring
- Lead trial document amendments and retraining
- Provide strategic communication and training to trial team
- Contribute to Trial Oversight Meetings and stakeholder inquiries
- Coordinate trial close-out activities including data delivery and quality review
Zentrale Anforderungen
- University degree in life sciences or related field or equivalent professional education with relevant experience
- At least five years of clinical operations experience
- Fluent in English
- Strong leadership and influencing skills
- Deep knowledge of ICH-GCP, regulatory requirements, and risk-based monitoring
- Profound CRA background with Lead level responsibilities and exposure to Clinical Trial Management tasks
- Experience managing complex trials across regions and vendors
- Demonstrates AAI approach in leading and decision-making
- leadership
- influencing
- clear communication
- risk-based monitoring
- site monitoring
- ICH-GCP compliance
Site Management 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.
