Clinical Trial Lead (m/w/d)
IQVIA
Clinical Trial Lead (m/w/d)
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.
Clinical Trial Lead (m/w/d)
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.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
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.