Senior Clinical Project Manager, Phase I

🕒 July 28

🌐 United States, Canada – Remote

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💵 $140k - $150k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 33%

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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

• Oversee and manage domestic, regional, and/or global clinical projects • Develop and manage project teams, communications, risk, scope, schedule, cost, quality, and stakeholders • Proactively mitigate variance from plan and meet client expectations • Apply working knowledge of drug development and clinical trial execution • Compile and drive project documentation, ensuring regulatory data accuracy and quality • Serve as key client contact and establish effective client project-team relationships • Lead core project teams and facilitate extended cross-functional project teams • Escalate project issues to internal and external stakeholders • Proactively identify and resolve conflicts • Manage project delivery against agreed time, scope, cost, and quality • Manage change control processes internally and externally • Lead quality control and risk assurance activities • Create, manage, and monitor project plans and revise them as necessary • Ensure staff adhere to professional standards and SOPs and provide performance feedback • Develop and maintain project performance indicators and client-specified KPIs • Define project resource needs and establish succession plans • Prepare and deliver new-business presentations • Train and mentor PM Academy PCs • Potentially provide line management and talent development • Align resources with current and forecasted work • Support onboarding, development, retention, succession, and competency planning • Provide line management and technical support to project leaders • Perform other assigned duties

🎯 Requirements

• 4-5+ years of global project management experience • Mandatory Phase I experience • 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 • Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO • At least two (2) years of full project management responsibility • 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 • 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 effective teamwork and motivate staff within a matrix system • Financial awareness and ability to use financial tracking systems • Good knowledge of project management processes • 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 • Preferred: Master’s or other advanced degree • Preferred: PMP certification • Preferred: Biotech experience • Preferred: Fluent in Chinese/Mandarin

🏖️ Benefits

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) • 401(K) • Paid time off (PTO) – Flex Plan • Employee recognition awards • Multiple ERG’s (employee resource groups)

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