Senior Clinical Project Manager – Cell & Gene Therapy

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Fortrea

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

• Accountable for project delivery with regards to agreed time, scope, cost, and quality. • Serve as key client contact for assigned projects, establishing working relationships with client project teams. • Lead core project teams and facilitate effective cross-functional teamwork among project members. • Proactively identify and resolve conflicts as needed. • Understand the project delivery strategy, costing assumptions and resulting budget for assigned projects. • Deliver projects to scope, schedule, and costs, ensuring all remain on track with the contract and financial performance targets. • Proactively lead both quality control and risk assurance activities to ensure project deliverables are met. • Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs. • In collaboration with relevant departments, prepare and deliver presentations for new business as required.

🎯 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. • 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 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.

🏖️ Benefits

• Standard Office Environment or remote based work required. • Weekend and off-hour work as required. • Local, Domestic, Regional, Global travel required.

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