
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.
🔥 45 minutes ago
🌐 Mexico, Brazil, +2 more countries – Remote
⏰ Full Time
🟡 Mid-level
🟠 Senior
👷♀️ Project Manager
👻 Ghost score 10%
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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; assist with Change Order Forms; provide vendor management and escalate out-of-scope activities • Update the Xcellerate Risk Identification and Issue Resolution (RIIM) tool and follow action items through resolution • Complete the Xcellerate Risk Assessment Categorization Tool (RACT) using the Xcellerate Risk library • Ensure Protocol Deviations are updated in Xcellerate RIIM • Update the Project Governance Tool monthly • Support identification, prevention, and closure of quality compliance gaps • Support audit and investigation preparation, including creation of issue storyboards • Support timely closure of audit/inspection CAPAs • Facilitate study team communication and collaboration through meetings, ADI logs, Task Order Matrix, Project Directory, distribution lists, SP sites, mailboxes, collaboration tools, and project-specific trackers • Collaborate with support functions on TMF uploading, TMF reviews, TMF issue resolution, systems access, project-specific training curricula, and delegated tasks • Monitor, escalate, and help enforce redaction of subject-sensitive information and identifiers in study documentation • Maintain the Lessons Learned tracker with the Study Team • Perform other duties as needed or assigned
• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from appropriately accredited institution • In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • 0-2 years of relevant industry experience • Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs preferred • Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point) • 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
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