Study Manager

Study Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

As a Study Manager at ICON, you will work cross -functionally within internal and external partners (e.g. vendors) to deliver delegated operational tasks from Initiation until study archiving to time, quality, budget, company standards.

What You Will Do:

In this role you will work in close partnership with the Global PM and Global Trial Managers on end-to-end operational study delivery activities, from study setup to study archival.


Key responsibilities include:

• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues.

• Support Global PMs in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties

• Oversight of Project Specialists activities and ensuring completeness of internal systems/databases/tracing tools and project plans.

• Facilitating and maintaining interactions and meetings with internal and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies

• Vendor management

• Coordinating study-related activities and overseeing study team's communication

• Overseeing delivery of clinical supplies, investigational products and all study materials

• Data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness

• Overseeing of budget tracking – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Global PM. 

Your Profile:

• At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.

• Knowledge of clinical trials, drug development process. 

• Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.

• Experience in using Trial Master File industry accepted standard. 

• Project management skills (preferably with analytical/financial skills) and good leadership skills.

• Excellent verbal and written communication in English. 

• Proven experience in clinical operations and/or study management is required

• Strong communication and relationship building skills, including external service provider management skill

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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