Clinical Team Lead – Invitro Diagnostics

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $135k - $143k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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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 • Function 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 • Represent clinical delivery to the customer • 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 work with clinical teams and stakeholders • Manage project scope, timelines, quality, budget, risks, resources, and KPIs • Prepare and deliver presentations for new business and participate in Bid Defense activities • Manage subject recruitment and retention, clinical vendor delivery, and monitoring visit strategy • Apply data sources, dashboards, risk management, and quality-by-design principles to support proactive problem solving • Maintain project governance, escalation pathways, clinical project plans, SOP compliance, and regulatory requirements • Forecast clinical project revenue and manage project costs and financial milestones • Lead scope changes and change-order processes • Build 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 • Participate in and oversee regulatory and ethics committee submissions, tracking, and documentation • Perform other assigned duties

🎯 Requirements

• 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 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, encourage independent problem-solving, 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 with clients professionally • Ability to present to staff at all levels • Fluent in English, written and verbal • Device experience preferred • Willingness/ability to work weekends and off-hours as required • Ability to travel up to 30% globally, including domestic and international travel