Senior Clinical Project Manager, Phase I

Job not on LinkedIn

🔥 12 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $140k - $150k / year

⏰ Full Time

🟠 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

• Oversee and manage domestic, regional and/or global projects • Develop and manage project teams, communications, risk, scope, schedule, cost, quality, and stakeholders • Ensure that variance from plan is proactively and effectively mitigated and client expectations are met • Compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data • Serve as key client contact for assigned projects • Lead core project team(s) and facilitate effective cross-functional teamwork among project team members • Serve as escalation point for project issues to internal and external stakeholders • Proactively identify and resolve conflicts as needed • Initiate and implement appropriate actions to manage change control process both internally and externally • Create and manage variance to required project plans • Ensure all staff allocated to assigned project(s) adheres to professional standards and SOPs • Aid in development and maintenance of key project performance indicators for client specified metrics • Define and manage project resource needs and establish succession plans for key resources • Prepare and deliver presentations for new business as required. • Train and mentor PM Academy PCs in multiple areas of expertise.

🎯 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 • Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO, including at least two (2) years of full project management responsibility. • Phase I 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. • 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. • Financial awareness and ability to actively utilize 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 in a professional manner. • Ability to present to staff at all levels.

🏖️ 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)