Amsterdam
1 day ago
Site Management Lead
IQVIA
Amsterdam
1 day ago
Site Management Lead
IQVIA is seeking a Site Management Lead to join its Clinical FSP department, providing site monitoring expertise to global clinical trial teams. The role involves leading trial-level planning, oversight, and risk management for site monitoring activities, requiring at least five years of clinical operations experience and deep knowledge of ICH-GCP.
HybridFull-timeMid LevelICH-GCPRisk-based Monitoring
Site Management Lead
IQVIA is seeking a Site Management Lead to join its Clinical FSP department, providing site monitoring expertise to global clinical trial teams. The role involves leading trial-level planning, oversight, and risk management for site monitoring activities, requiring at least five years of clinical operations experience and deep knowledge of ICH-GCP.
HybridFull-timeMid LevelICH-GCP
Salary
Not specified
Core Qualifications
Technical (Must-have)
ICH-GCPRisk-based monitoringClinical operationsSite monitoringClinical Trial ManagementCRO oversightRegulatory requirementsInspection readinessIssue managementRisk mitigationTrial-level document authoringTraining deliveryOversight visitsData cleaning and deliveryAAI approach
Soft Skills
LeadershipInfluencingCommunicationStrategic communicationDecision-makingProblem solvingCollaboration
Key Responsibilities
- Lead planning of trial quality and risk monitoring/mitigation
- Accountable for development and implementation of operational Site Monitoring & Oversight plans
- Deliver training and guidance to CT Managers and CRAs
- Independently author and review trial-level documents
- Act as subject matter expert on site management and monitoring topics
- Join and present at global/regional/local Trial Team meetings and Investigator Meetings
- Integrate patient/site level feedback to documents ensuring design with a focus on patient and patient safety
- Represent monitoring strategy in global/regional/local meetings
- Timely responses to Site Management and monitoring questions from external and internal stakeholders
- Facilitate communication and direction with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs
- Independently oversee CRO performance and adherence to ICH-GCP and SOPs
- Drive issue management and resolution at trial level
- Proactively identify trial and site level risks and implement mitigation strategies
- Maintain and update Site Monitoring plan and trial-level documents
- Conduct oversight visits and ensure follow-up actions
- Lead preparation and implementation of trial document amendments and retraining
- Provide strategic communication and training
- Participate, prepare input and (co-) lead Trial Oversight Meetings
- Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries
- Support compilation and review of the quality section for the clinical trial report for site monitoring activities
Site Management LeadClinical TrialsHospitals and Health CareProject ManagementInformation TechnologyHybridFull-timeAmsterdamICH-GCPCRA