Clinical Trial Manager

🔥 3 hours ago

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• The LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level • Managing the consistency of Local Trial Management duties and processes • Serve as the country-level single point of contact on the study for internal partners • Manage and oversee Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable • Execution of local milestones from feasibility through study close out • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM) • Inspection Readiness and AQR at the country level • Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary • Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence • Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables • Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

🎯 Requirements

• BA/BS degree • Degree in a health or science related field • 2 years of local trial management experience required • Start-up & Database Locks/Cleaning experience preferred • Cross therapeutic area trial management experience required • Oncology trial management experience required, Early Development experience an asset • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations (i.e. Canadian), REB submissions, assigned protocols and associated protocol specific procedures. • Strong IT skills in appropriate software and company systems • Willingness to travel with occasional overnight stay away from home according to business needs • Proficient in speaking and writing the country language and English. • Good written and oral communication skills as appropriate • Must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status

🏖️ 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