Clinical Project Manager II – Phase I

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $120k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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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 the operational strategy for clinical projects, determining cost-effective and efficient approaches to complete projects on time, within budget, and to quality standards • Develop and lead high-performing teams across the end-to-end project lifecycle • Drive project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence • Own customer relationships and draw on the Company's pool of experts • Drive communication and collaboration with clients and project teams in a matrixed, multicultural environment • Lead project strategy development and prioritize scope, timelines, quality, and budget using clear, data-driven strategies • Prepare and deliver presentations for new business as required • Identify 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 • Ensure adherence to project governance, issue escalation pathways, professional standards, SOPs, client requirements, and regulatory requirements • Oversee and manage project budgets, resources, and scope • Ensure budget and financial milestone adherence; forecast project revenue and manage project costs • Manage scope changes and the change order process • Track KPIs for client-specific metrics • Facilitate communication and teamwork while driving delivery • Ensure resource projections are accurate and visible to resourcing teams; escalate resource constraints • Develop and mentor team members and provide feedback to line managers • Perform other duties as assigned

🎯 Requirements

• Candidates must be based in the United States • University/college degree (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 • Minimum of five (5) years of relevant clinical research experience in a pharmaceutical company/CRO • 2+ years of Clinical Project Management experience within a CRO or pharma company • Experience working on Phase I studies • Alternative: six (6) years supervisory experience in a health care setting and five (5) years clinical research experience including one (1) year of project management experience • 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 a matrix and virtual environment • Excellent communication, planning, and organizational skills • Demonstrated ability to lead by example and encourage team members to seek solutions independently • Demonstrated ability to handle multiple competing priorities and utilize resources effectively • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system • Financial awareness and ability to actively utilize 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 • Master's or other advanced degree preferred • PMP certification preferred • Weekend and off-hour work as required • Travel up to 30%: local, domestic, regional, and global

🏖️ Benefits

• Medical • Dental • Vision • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable • Remote based work option • Standard Office Environment or remote based work required • Professional development and mentorship through developing and mentoring team members