2 days ago

Clinical Trial Lead (m/w/d)

IQVIA

Amsterdam

2 days ago

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IQVIA is seeking a Clinical Trial Lead to be accountable for the operational performance of complex Phase III clinical trials, from preparation through close-out and reporting. The role requires extensive global clinical operations leadership, including at least 10 years of clinical research experience and 5 years in global trial management, with strong knowledge of GCP and ICH guidelines. The position is hybrid in Amsterdam and involves leading cross-functional trial teams and driving protocol development.

HybridFull-timeSeniorClinical Trial ManagementPhase III Clinical Trials

Clinical Trial Lead (m/w/d)

Apply

HybridFull-timeSeniorClinical Trial Management

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Hybrid

Experience Required

10 years

Employment Type

Full-time

Experience Level

Minimum 10 years of relevant clinical research experience, including at least 5 years in global clinical trial management

Core Qualifications

Technical (Must-have)

Clinical trial managementPhase III clinical trialsProtocol developmentGCPICH guidelinesCTRSOPsRisk managementMicrosoft WordMicrosoft ExcelMicrosoft PowerPointClinical trial management systems

Soft Skills

LeadershipInfluenceCommunicationStakeholder managementActive listeningCultural awarenessProject managementRisk and issue managementConflict managementResilienceMatrix collaboration

Key Responsibilities

•Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III clinical trials with accountability for timelines, quality, budget awareness, and operational execution.
•Drive protocol development together with medical, statistical, and cross-functional stakeholders, ensuring operational feasibility, implementation readiness, and translation of protocol requirements into clear study execution plans.
•Lead end-to-end trial delivery independently, covering study preparation, setup, initiation, conduct, close-out, reporting, governance, documentation, and performance oversight.
•Act as the primary driver of study execution and the main operational point of contact for trial progress at global level, governance, issue resolution, risk management, and escalation.
•Provide leadership to interdisciplinary core trial teams, including local/regional clinical operations functions, data management, statistics, pharmacokinetics, safety, medical, and other relevant functions.
•Facilitate effective trial governance, including Trial Oversight Meetings and other relevant forums, ensuring clear decisions, actions, ownership, and follow-up.
•Author study plans, tools, training materials, quality plans, risk management plans and other operational documentation and ensure are fit for purpose and consistently implemented.
•Monitor trial progress using dashboards, metrics, system data, and operational reviews to ensure timely and accurate reporting, system compliance, and milestone achievement.
•Manage study risks and quality issues proactively, including risk identification, impact assessment, mitigation planning, communication, escalation, and corrective or preventive action tracking.
•Work effectively within complex matrix organizations across functions, geographies, cultures, and external partner interfaces.
•Support continuous improvement by contributing to process optimization, cross-functional initiatives, and adoption of relevant technology, tools, and practices.

Clinical Trial LeadClinical ResearchPhase IIIGlobal Clinical OperationsHybridAmsterdamIQVIAGCPICHCRO

Core Qualifications

Technical (Must-have)

Clinical trial managementPhase III clinical trialsProtocol developmentGCPICH guidelinesCTRSOPsRisk managementMicrosoft WordMicrosoft ExcelMicrosoft PowerPointClinical trial management systems

Soft Skills

LeadershipInfluenceCommunicationStakeholder managementActive listeningCultural awarenessProject managementRisk and issue managementConflict managementResilienceMatrix collaboration

Key Responsibilities

•Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III clinical trials with accountability for timelines, quality, budget awareness, and operational execution.

•Drive protocol development together with medical, statistical, and cross-functional stakeholders, ensuring operational feasibility, implementation readiness, and translation of protocol requirements into clear study execution plans.

•Lead end-to-end trial delivery independently, covering study preparation, setup, initiation, conduct, close-out, reporting, governance, documentation, and performance oversight.

•Act as the primary driver of study execution and the main operational point of contact for trial progress at global level, governance, issue resolution, risk management, and escalation.

•Provide leadership to interdisciplinary core trial teams, including local/regional clinical operations functions, data management, statistics, pharmacokinetics, safety, medical, and other relevant functions.

•Facilitate effective trial governance, including Trial Oversight Meetings and other relevant forums, ensuring clear decisions, actions, ownership, and follow-up.

•Author study plans, tools, training materials, quality plans, risk management plans and other operational documentation and ensure are fit for purpose and consistently implemented.

•Monitor trial progress using dashboards, metrics, system data, and operational reviews to ensure timely and accurate reporting, system compliance, and milestone achievement.

•Manage study risks and quality issues proactively, including risk identification, impact assessment, mitigation planning, communication, escalation, and corrective or preventive action tracking.

•Work effectively within complex matrix organizations across functions, geographies, cultures, and external partner interfaces.

•Support continuous improvement by contributing to process optimization, cross-functional initiatives, and adoption of relevant technology, tools, and practices.