Clinical Trial Lead (m/w/d)
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The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client’s project team to set-up and execute clinical trials. As Clinical Trial Leader (m/w/d) you will be accountable for the operational performance of the trial (preparation, initiation, conduct, close-out and reporting). As such you will manage cross-functional trial teams at the customer, acting as that accountable point for delivery and quality whilst maintaining financial control.
You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics. 1. Role purpose As Clinical Trial Leader, you will act as the primary driver of study execution and be accountable for the operational performance of assigned clinical trials across preparation, initiation, conduct, close-out, and reporting. You will lead global, cross-functional trial teams and be accountable for delivery, quality, compliance, timelines, risk management, and financial oversight.
The role requires a highly experienced global clinical operations leader with strong Phase III and end-to-end trial delivery experience, and proven capability to drive protocol development in partnership with medical, statistical, and cross-functional stakeholders. You will translate complex scientific, medical, statistical, and operational requirements into executable trial delivery plans and provide leadership throughout the trial lifecycle.
Success in this role requires the ability to rapidly integrate into ongoing programs, create clarity in complex matrix environments, proactively identify and manage risks, escalate issues appropriately, resolve conflict constructively, and maintain strong stakeholder communication and alignment. The Clinical Trial Leader is expected to operate with a high degree of independence, ensuring study objectives are delivered while protecting quality, compliance, timelines, and budget control.
2. Key accountabilities and 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, to