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Global CTM

ICON plc
Polandfull_timeVerifiedPosted 20 Dec 2024

About the role

<h2>Overview</h2> <p><strong>Job title - Senior Clinical Trial Manager </strong></p> <p><strong>Location - UK, nationwide travel </strong></p> <p><strong>Fully Sponsor dedicated</strong></p> <p> </p> <p>As a CTM you will be joining the world’s largest &amp; most comprehensive clinical research organisation, powered by healthcare intelligence.</p> <h2>Responsibilities</h2> <p>The Senior Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.</p> <p> </p> <p><strong>Additional responsibilities include:</strong></p> <p> </p> <ul> <li>Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.</li> <li>Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.</li> <li>Lead the evaluation and selection of investigative sites; responsible for feasibility.</li> <li>Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co-monitoring,as needed</li> <li>Develop and manage trial(s) timelines, budget and priorities.</li> <li>Participate in data review and discrepancy resolution.</li> <li>Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.</li> <li>Generate reports to update management on conduct of trial.</li> <li>Ensure appropriate clinical trial supply plans are implemented and managed.</li> <li>Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.</li> <li>Participate in monitoring study safety.</li> <li>Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team. </li> <li>Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in acordance with scope of work.</li> <li>Assist with CRA and third party vendor training on protocols and practices.</li> </ul> <h2>Qualifications</h2> <p><strong>You must have:</strong></p> <p> </p> <ul> <li>BS/BA degree or a relevant degree with strong emphasis on science.</li> <li>Right to work in the UK </li> <li>Experience working within a global capacity</li> <li>Minimum of four years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.</li> <li>Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.</li> <li>Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.</li> <li>Demonstrate leadership and problem solving skills.</li> <li>Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).</li> <li>Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.</li> <li>Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.</li> </ul> <p> </p> <p> </p> <p><strong>What ICON can offer you:</strong>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:</p> <ul> <li>Various annual leave entitlements</li> <li>A range of health insurance offerings to suit you and your family’s needs</li> <li>Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead</li> <li>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</li> <li>Life assurance</li> <li>Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others</li> </ul> <p>Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion &amp; 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 b

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ICON plc

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