Clinical Trial Manager

As a Clinical Trial Manager (IVD) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Career Responsibilities

• Designs, plans and executes study management and clinical monitoring activities of large-scale trials in support of IVDR submissions for diagnostic devices. 
• Prepare and author IVDR gap assessments and Clinical Performance Reports.
• Provide comprehensive support of all operational aspects of clinical trials for which he/she is responsible for, including the review and approval of protocols and study-related documents (e.g., Regulatory Binder, Work Instructions, CRF Completion Guidelines, etc.)
• Effectively lead the operational clinical team for assigned studies and delegate appropriate tasks, assignments, and responsibilities to subordinates.
• Develop and administer budgets, schedules and performance requirements for assigned studies.
• Oversee the successful and efficient execution of assigned studies from study start up to study close out.
• Participate in CRO/vendor selection process for outsourced activities as applicable.
• Manage Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management) as applicable. 
• Collaborate with the Legal Department to develop study contract templates across the trial and specifically for each study site.
• Provide feedback on study/protocol design as needed
• Develops the Site Monitoring Plan and ensures CRA compliance with the plan
• Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
• Participates in site start-up activities including site selection and regulatory document collection, review, approval and tracking; development of informed consent forms /assent forms as applicable
• Works under minimal supervision and demonstrates a high degree of proficiency
• Additional project and tasks as determined by department and organizational needs
• Travel may be approximately 20-50% 

Technical skills/Knowledge/Abilities

• Strong technical writing skills
• Deep understanding of IVDR and applications
• Advanced knowledge of clinical trial practices and regulations
• Advanced knowledge of clinical trial, design, clinical trial databases, and data analysis for IVD clinical trials
• Proficient computer skills including Microsoft Office Suite

Education & Experience

Minimum BA or BS and 10 years of related experience; Master’s degree or Medical Technology Certification, familiarity with IVDR, experience with managing external CROs and on-site monitoring experience of IVD clinical studies is preferred. 

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.