
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.
🔥 5 hours ago
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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.
• Work with the project team to set up and maintain project schedules • Update timelines in MS Project, CTMS, project governance tools, and other trackers; escalate timeline risks • Assist the Project Lead with timesheet-versus-budget reviews, vendor financial tracking and reconciliation, sponsor contract financial tracking and reconciliation, and final project financial reconciliation • Conduct Contract versus Study Plan Reviews with the Project Lead • Maintain out-of-scope work trackers and assist with Change Order Forms • Provide vendor management and escalate out-of-scope activities • Update risk identification, issue resolution, risk assessment, and protocol deviation tools • Follow outstanding action items through resolution • Update the Project Governance Tool monthly • Support identification, prevention, and closure of quality compliance gaps • Support audit and investigation preparation, including issue storyboards • Support timely closure of audit/inspection CAPAs • Facilitate study team communication by arranging meetings and maintaining logs, matrices, directories, distribution lists, SharePoint sites, mailboxes, and project trackers • Collaborate with support functions on TMF uploads, reviews, issue resolution, systems access, project-specific training, and delegated tasks • Monitor, escalate, and help enforce redaction of subject-sensitive information and identifiers in study documentation • Maintain the Lessons Learned tracker • Perform other duties as assigned
• University/college degree (life science preferred), or certification in a related allied health profession (e.g., nursing, medical or laboratory technology) from an appropriately accredited institution • In lieu of the above, three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries, or experience in a health care setting, will be considered • Relevant and equivalent experience may be considered in lieu of educational requirements • 0–2 years of relevant industry experience • Knowledge of ICH Guidelines and GCP, including international regulatory requirements for clinical development programs, preferred • Computer competency with Microsoft Word, Excel, Project, Access, and PowerPoint • Ability to develop accurate study-related documents with minimal supervision • Ability to communicate verbally and in writing • Must be able to work at a computer keyboard 6–8 hours per day • Must be flexible to accept changes in work assignments as business needs require
• Face-to-face, continuous learning environment through the Project Management Academy • Mentorship and support from Project Leads, Line Manager, mentor, and subject matter experts • Opportunity to mentor other PM Academy Project Coordinators in areas of expertise
Apply Now🔥 6 hours ago
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