Clinical Project Manager II – Phase I

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Project Managers own the operational strategy, determining the most cost effective and efficient means to successfully run and complete projects on time, while maintaining quality, remaining within budget, while meeting the customer’s needs and adhering to the contract. • Develop and lead high performing teams by collaborating with key stakeholders to manage all aspects of the end-to-end lifecycle of the project including scope, timelines, risk, and budget. • Take accountability for proactively driving project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence. • Drive communication and collaboration with the client and project team across a matrixed, multi-cultural, environment. • Lead the development of the project strategy and ensure prioritization with the project team and key stakeholders in the creation of clear, data driven strategies and proactive management of project scope, timelines, quality, and budget. • In collaboration with relevant departments, prepare and deliver presentations for new business as required. • Lead the identification of project, financial and quality risk leveraging end to end risk management practices and quality by design principles. • Appropriately utilize data sources, dashboards, and risk management strategies to drive innovation and proactive problem solving with the project and client teams. • Lead the adherence to project governance and issue escalation pathways, ensuring that project plans are in place to address identified risk while adhering to professional standards, SOPs, client, and regulatory requirements.

🎯 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 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. • 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. • 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 in a professional manner.

🏖️ 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)