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Global Study Manager

Job not on LinkedIn

🕒 May 2

🌐 United States, Canada – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 55%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Provide operational leadership across the full clinical study lifecycle • Lead global clinical trials from sourcing strategy and RFP development through study start-up, execution, database release, and inspection readiness • Represent the operational function on the core study team • Drive recruitment strategies and milestone delivery • Lead and coordinate internal teams, external partners, and vendors • Oversee study-level plans, performance metrics, vendor scope, budgets, and risk mitigation • Form, oversee, and lead the operational sub team and request resources • Develop study startup, study management, monitoring, sourcing, recruitment, and related plans • Coordinate protocol training and global investigator meetings • Oversee country-level feasibility, site approval, and site activation plans • Manage study management and country/site-level documents and risk planning inputs • Develop clinical trial budget inputs and monitor vendor budgets, contracts, expenses, invoices, purchase orders, and forecasts • Ensure delivery of the study against approved plans • Lead inspection readiness and site readiness activities • Support decentralized capabilities at investigator sites • Ensure timely study closure and release of resources after database lock • Oversee drug supply management and interactive randomization system setup • Review feasibility outputs and pre-trial assessment reports • Support study-level submission readiness and vendor UAT/system setup reviews • Ensure applicable system closure at study completion • Oversee study startup and monitoring functions for SOP and quality compliance • Coordinate with data management and review data reports and dashboards to identify risks • Escalate plan deviations and oversee mitigations • Assess enrollment and discontinuations for financial forecasting • Provide operational input into protocol design • Lead protocol deviation trend reviews and vendor calls • Serve as technical expert for study management systems and processes • Champion harmonized processes and high-quality, cost-effective clinical trial data • Provide technical oversight, performance feedback, metrics review, and issue escalation/resolution • Partner with operational teams and pCROs to resolve performance issues • Support audits and inspections

🎯 Requirements

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology • BA/BS 7+ years of relevant experience • MBA/MS/ 6+ years of relevant experience • Demonstrated clinical research experience and/or study management experience • Demonstrated study management/leadership experience • Demonstrated oversight of CROs/vendors • Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend • Exceptional knowledge of own discipline and advanced knowledge of others • Ability to develop ideas and lead complex projects • Ability to develop innovative solutions to complex problems • Ability to work independently with assignments often self-initiated • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways

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