
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.
🕒 August 18
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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 • Function as Clinical Project Manager within the core project team • Partner with Project Manager and functional leads to deliver clinical trial aspects within contractual and budgetary requirements • Oversee clinical and site management aspects of trials • Represent clinical delivery to customers • Drive project performance toward contracted deliverables and customer needs • Lead communication and collaboration with clients and matrixed project teams • Develop clinical project strategy and prioritize scope, timelines, quality, and budget • Prepare and deliver presentations for new business • Manage subject recruitment and retention, clinical vendor delivery, and monitoring visit strategy • Identify and manage clinical, financial, and quality risks • Use data sources, dashboards, and risk management strategies for proactive problem solving • Maintain project governance, escalation pathways, clinical project plans, SOP, client, and regulatory compliance • Manage project budgets, resources, scope, revenue forecasts, and costs • Lead scope changes and change order processes; track KPIs • Build high-performing clinical project teams and facilitate teamwork • Maintain accurate clinical resource projections and escalate constraints • Develop and mentor team members and provide feedback to line managers • Oversee regulatory/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 • Relevant and equivalent experience may be considered in lieu of educational requirements • Bachelor's degree • 5+ years of 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, closeout, and report writing • 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 matrix and virtual environments • Excellent communication, planning, and organizational skills • Ability to lead by example and encourage independent solution-seeking • Ability to manage competing priorities and utilize 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 professionally with clients • Ability to present to staff at all levels • Fluent in English, written and verbal
• 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)
Apply Now🕒 August 18
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