Senior Study Delivery Lead

Global Project Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.

Ideally, you will be a Project Manager or experienced Senior Clinical Trial Manager with retrospective and prospective designs, post authorization safety studies, real world evidence, and epidemiology experience. This is a leadership role, and you need to demonstrate global clinical study management experience in leading and driving cross-functional teams.

• This position combines end-to-end design, execution, and reporting of clinical studies and trials including:
• Non-interventional studies using primary data collection, including prospective studies enrolling patients and / or HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g. with EMRs / chart abstraction), patient reported outcomes development and validation.
• Global clinical study management experience across different countries and regions is essential to succeed in the role.
• Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence / incidence studies of exposure, risk factors and outcomes.
• Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients.
• Economic modelling studies and supplemental analyses of clinical trials / meta-analyses.
• Interventional and low-interventional studies.

This Includes Responsibility And / Or Accountability For The Set-up, Coordination, Execution And Delivery Of Studies In Partnership With The Science Lead

• Planning and leading the delivery of NIS to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
• Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
• Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms / tools etc).
• With the majority of NIS fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH / GCP & ENCePP guidelines and/or applicable guidelines for studies
• Make decisions which balance risk / benefit. Mitigate risk where appropriate.
• Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.
• Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills.

• Leadership of a study team with single point accountability for delivery of the study
• Have primary responsibility and be a focal point of contact for interactions with key stakeholder groups including lead scientists…