Clinical Team Lead, FSP – Invitro Diagnostics

🕒 September 8

🇺🇸 United States – Remote

💵 $135k - $143k / year

⏰ Full Time

🟠 Senior

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Logo of Fortrea

Fortrea

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 the Clinical Project Manager within the core project team • Partner with the Project Manager and functional leads to deliver clinical trial activities within contractual and budgetary requirements • Oversee clinical and site management aspects of trials and represent clinical delivery to customers • Drive project performance toward contracted deliverables and customer needs • Lead communication and collaboration with clients and matrixed, multicultural project teams • Develop clinical project strategy and manage project scope, timelines, quality, and budget • Prepare and deliver new-business presentations as required • Manage subject recruitment and retention, 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 strategies to drive innovation and proactive problem solving • Maintain project governance, issue escalation pathways, project plans, SOP, client, and regulatory compliance • Manage clinical project budgets, resources, scope, revenue forecasts, costs, and financial milestones • Lead scope changes and change-order processes and track client-specific KPIs • Build high-performing clinical project teams and ensure members understand scope, timelines, and budget • Maintain accurate clinical resource projections and escalate resourcing constraints • Develop and mentor team members and provide feedback to line managers • Participate in and oversee regulatory and ethics committee submissions, tracking, and documentation • Support new business through Bid Defense preparation and meetings • 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 • Bachelor's degree • 5+ years clinical research/monitoring experience or equivalent combination of education and experience • 3+ years leading project teams through clinical study start-up, conduct, data management, analysis, closeout, and report writing • Experience overseeing 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, handle 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 professionally with clients • Ability to present to staff at all levels • Fluent in English, written and verbal • Preferred: Master's or other advanced degree • Preferred: Device experience • Weekend and off-hour work as required • Up to 30% global travel, including domestic and international travel

🏖️ Benefits

• Remote US-based work option • Standard office environment or remote-based work • Professional development through mentoring and feedback • Global and domestic/international travel opportunities

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