Clinical Trial Manager - Real World Evidence

April 8

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ICON plc

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ICON plc is a leading Contract Research Organization (CRO) that provides comprehensive clinical, consulting, and commercial services to the biopharmaceutical industry. With a focus on innovative solutions, ICON supports the development of transformative therapies by offering a range of services including clinical trials, regulatory affairs, and market access strategies. The company is dedicated to advancing drug development through its global expertise and cutting-edge technology.

Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes

10,000+ employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Deliver Trials(s) on time, within budget, and with highest achievable quality • Assist in the review, development and/or writing of clinical trial documents and manuals as needed, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents • Manage the evaluation and selection of investigative sites for applicable clinical trials, responsible for feasibility • Select, coordinate, and monitor activities of vendors • Review of monitoring reports and conduct co-monitoring visits, as needed • Develop and manage trial(s) timelines, budget and priorities • Participate in data review and discrepancy resolution • Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress • Generate reports to update management on progress of the clinical trial(s) • Ensure appropriate clinical trial supply plans are implemented and managed where appropriate • Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required • Participate in monitoring study/program safety • Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team • Perform initial review of CRO and other third-party vendor training on protocols, guidelines, and/or practices • Lead multi-disciplinary trial teams, including the study team meetings • Function as the primary contact for program(s) between Drug Development and other departments

🎯 Requirements

• BS/BA degree or a relevant degree with strong emphasis on science or equivalent experience • Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management, and especially closeout and termination of multinational clinical trials with a focus on skills and competencies rather than specific years of experience • Experience in the biopharmaceutical industry or other relevant global clinical research programs in the initiation and management of continued access/post-trial access programs • Ability to manage complex and/or large clinical/medical programs • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience • Ability to effectively manage multiple priorities across several programs and therapeutic areas simultaneously • Demonstrated leadership and problem-solving skills • Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)

🏖️ Benefits

• 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