
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
🔥 13 hours ago
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10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
• Own clinical delivery of clinical research trials as Clinical Team Lead • Function as Clinical Project Manager within the core project team • Partner with the Project Manager and functional leads to deliver clinical trial aspects within contractual and budgetary requirements • Oversee clinical and site management aspects of trials and represent clinical delivery to customers • Drive clinical project performance toward contracted deliverables and customer needs • Lead communication and collaboration with clients and project teams in a matrixed, multicultural environment • Develop clinical project strategies and prioritize data-driven strategies with stakeholders • Manage project scope, timelines, quality, budget, recruitment, retention, vendor delivery, and monitoring visit strategy • Identify clinical, financial, and quality risks and apply risk management and quality-by-design practices • Use data sources, dashboards, and risk management strategies to support innovation and problem solving • Maintain project governance, escalation pathways, project plans, SOP, client, and regulatory compliance • Manage clinical project budgets, resources, scope, revenue forecasts, costs, KPIs, and change orders • Provide leadership to high-performing clinical project teams and facilitate communication and teamwork • Ensure accurate clinical resource projections and escalate resource constraints • Develop and mentor team members and provide feedback to line managers • Oversee regulatory and ethics committee submissions, tracking, and documentation • Participate in bid defense preparation and meetings • Perform other duties as assigned
• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • Bachelor's degree • 5+ years clinical research/monitoring experience or equivalent combination of education and experience • 3+ years of experience leading project teams through clinical study start-up, conduct, data management, analysis, close out, and report writing • Prior monitoring experience required • Experience providing oversight to external vendors, such as CROs, central labs, call centers, and DCT providers • Working knowledge of ICH Guidelines and GCP, including international regulatory requirements • Advanced computer skills, including Microsoft Word, Excel, Project, Access, and PowerPoint • Experience managing projects in a matrix and virtual environment • Excellent communication, planning, and organizational skills • Ability to lead by example, encourage independent problem-solving, manage competing priorities, and use resources effectively • Ability to inspire teamwork and motivate staff within a matrix system • Financial awareness and ability to use financial tracking systems • Ability to work independently and mentor junior project team members • Ability to negotiate and liaise with clients professionally • Ability to present to staff at all levels • Fluent in English, written and verbal • Ability to work weekends and off-hours as required • Ability to travel up to 30% globally, primarily domestic and international
• Remote-based work option • Standard office environment or remote-based work • Weekend and off-hour work as required • Travel opportunities/requirements up to 30% (global, primary domestic and international) • EEO and accommodations support
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