3 days ago

Site Management Lead

IQVIA

Amsterdam

3 days ago

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IQVIA Clinical FSP is seeking a Site Management Lead to oversee site monitoring activities for clinical trials. The role involves leading trial preparation, conduct, and close-out, managing CRO performance, and ensuring compliance with ICH-GCP. Requires at least five years of clinical operations experience, a CRA background, and strong leadership skills.

HybridFull-timeEntry LevelICH-GCPRisk-Based Monitoring

Site Management Lead

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HybridFull-timeEntry LevelICH-GCP

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Hybrid

Experience Required

5 years

Employment Type

Full-time

Experience Level

Not Applicable

Core Qualifications

Technical (Must-have)

ICH-GCPRisk-Based MonitoringClinical OperationsSite MonitoringCRO OversightTrial ManagementRegulatory RequirementsLeadershipInfluencingCommunicationTrainingIssue ManagementRisk AssessmentSignal DetectionTrend Analysis

Soft Skills

LeadershipInfluencingCommunicationDecision-making

Key Responsibilities

•Lead planning of trial quality and risk monitoring/mitigation.
•Develop and implement operational Site Monitoring & Oversight plans.
•Deliver training and guidance to CT Managers and CRAs.
•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.
•Represent monitoring strategy in meetings.
•Respond to Site Management and monitoring questions from stakeholders.
•Facilitate communication with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs.
•Oversee CRO performance and adherence to ICH-GCP and SOPs.
•Drive issue management and resolution at trial level.
•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.
•Support compilation and review of quality section for clinical trial report.

Clinical TrialsSite ManagementClinical OperationsICH-GCPRisk-Based MonitoringCRO OversightHealthcarePharmaceuticalFull-timeHybrid

Key Responsibilities

•Lead planning of trial quality and risk monitoring/mitigation.

•Develop and implement operational Site Monitoring & Oversight plans.

•Deliver training and guidance to CT Managers and CRAs.

•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.

•Represent monitoring strategy in meetings.

•Respond to Site Management and monitoring questions from stakeholders.

•Facilitate communication with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs.

•Oversee CRO performance and adherence to ICH-GCP and SOPs.

•Drive issue management and resolution at trial level.

•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.

•Support compilation and review of quality section for clinical trial report.