Clinical Team Lead, Phase I

🔥 0 minutes ago

🌐 Mexico, Canada, +1 more countries – Remote

🇲🇽 Mexico – Remote 🇨🇦 Canada – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

✨ Team Lead

👻 Ghost score 10%

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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

• Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards • Own clinical delivery of clinical research trials and function as the Clinical Project Manager within the core project team • Partner with the Project Manager and functional leads to ensure successful delivery of clinical trial activities within contractual and budgetary requirements • Oversee clinical and site management aspects of trials and represent clinical delivery with customers • Drive clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence • Drive communication and collaboration with clients and project teams in a matrixed, multicultural environment • Lead clinical project strategy development and prioritization, including management of project scope, timelines, quality and budget • Prepare and deliver presentations for new business as required • Manage project operations supporting subject recruitment and retention, clinical vendor delivery and monitoring visit strategy • Identify clinical project, financial and quality risks using end-to-end risk management and quality-by-design principles • Use data sources, dashboards and risk management strategies to drive innovation and proactive problem solving • Maintain project governance and issue escalation pathways, including clinical project plans addressing identified risks • Oversee clinical project budgets, resources and scope; ensure budget and financial milestone adherence • Forecast clinical project revenue and manage project costs within budget • Lead scope changes and the change order process; track KPIs for client-specific metrics • Provide leadership for high-performing clinical project teams and facilitate communication, teamwork and delivery • 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/ethics committee submissions, tracking and documentation • Support new business through Bid Defense preparation and meetings • Perform other duties as needed or assigned

🎯 Requirements

• University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • Fluent in English, both written and verbal • 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job • Phase I/FIH experience • Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs • Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point) • Experience managing projects in a matrix and virtual environment • Excellent communication, planning and organizational skills • Demonstrated ability to lead by example and to encourage team members to seek solutions independently • Demonstrated ability to handle multiple competing priorities and to utilize resources effectively • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system • Financial awareness and ability to actively and effectively utilize financial tracking systems • Ability to work independently and mentor junior project team members • Ability to negotiate and liaise with clients in a professional manner • Ability to present to staff at all levels • Preferred: Master or other advanced degree • Preferred: PMP certification • Preferred: 2+ years CRA experience, on-site or in-house

🏖️ Benefits

• Equal Employment Opportunity and accommodations support • Remote/homebased work arrangement