Project Manager

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

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

• Lead, manage, and coordinate operational implementation of Non-Amgen Sponsored Clinical Research (NASCR) from submission receipt through close-out • Manage and oversee one or more ISS product portfolios, including multi-regional studies • Lead NASCR activities in accordance with global ISS and EA SOPs • Coordinate review and approval of ISS proposals and protocols with cross-functional teams and governance bodies • Liaise with the Sponsor and cross-functional teams to facilitate ISS activities from proposal receipt through close-out • Facilitate sponsor communication and ensure quality and completeness of the end-to-end NASCR process • Ensure execution of Confidential Disclosure Agreements and completion of sponsor qualification • Facilitate cross-functional reviews of proposals, protocols, and amendments • Facilitate or support internal and sponsor meetings, including agendas and minutes • Ensure Fair Market Value assessment for funded ISS • Coordinate protocol submission, study packages, contracts, regulatory documents, and essential documentation • Partner with Supply Chain representatives on investigational product supply, temperature excursions, and product complaints • Ensure completion and re-evaluation of ISS Regulatory Assessment and Initiation Package documents • Update source systems, including milestone tracking and enrolment status

🎯 Requirements

• Legal right to work in the country where the role is based • Experience managing and overseeing one or more ISS product portfolios, including multi-regional studies • Knowledge of global Investigator Sponsored Studies (ISS) and Expanded Access (EA) SOPs and supporting documentation • Experience coordinating proposal and protocol review and approval with cross-functional teams and governance bodies • Experience facilitating sponsor and cross-functional team activities from proposal receipt through close-out • Experience with Confidential Disclosure Agreements, sponsor qualification, contracts, regulatory and quality documentation, supply chain coordination, and essential document management • Ability to facilitate internal and sponsor meetings, including agendas and minutes • Ability to conduct Fair Market Value assessments for funded ISS • Ability to maintain milestone tracking, enrolment status, archiving, and reconciliation of essential documentation

🏖️ 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