Clinical Team Lead – Ophthalmology

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $135k - $145k / year

⏰ Full Time

🟠 Senior

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Fortrea

WebsiteLinkedInAll Job Openings

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.

📋 Description

• 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 • Represent clinical delivery to customers • Drive clinical project performance toward contracted deliverables and customer needs • Lead communication and collaboration with clients and matrixed, multicultural project teams • Develop clinical project strategy and prioritize data-driven strategies with stakeholders • Proactively manage project scope, timelines, quality, and budget • Prepare and deliver presentations for new business • Manage project operations supporting subject recruitment and retention • Oversee clinical vendor delivery and monitoring visit strategy • Identify and manage clinical, financial, and quality risks using risk management and quality-by-design practices • Use data sources, dashboards, and risk management strategies for proactive problem solving • Maintain project governance, issue escalation pathways, clinical project plans, SOPs, client requirements, and regulatory requirements • Oversee clinical project budgets, resources, scope, revenue forecasting, costs, financial milestones, KPIs, and change orders • Provide leadership for high-performing clinical project teams • Facilitate communication, teamwork, and delivery while ensuring scope, timelines, and budget awareness • Ensure accurate clinical resource projections and escalate resource constraints • Develop and mentor team members and provide feedback to line managers • Participate in and oversee regulatory and ethics committee submissions, tracking, and documentation • Participate in Bid Defense preparation and meetings as required • Perform other duties as assigned

🎯 Requirements

• University/college degree in 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 of clinical research/monitoring experience or equivalent combination of education and experience • 3+ years of experience leading project teams through study start-up, conduct, data management, analysis, closeout, 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 matrix and virtual environments • Excellent communication, planning, and organizational skills • Ability to lead by example and encourage team members to seek solutions independently • Ability to handle multiple 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 • Up to 30% global travel, primarily domestic and international • Weekend and off-hour work as required

🏖️ Benefits

• Remote-based work option • Standard office environment or remote-based work • Fortrea EEO & accommodations support