
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.
🕒 September 14
Where this job comes from
Posted on Fortrea's careers page, not through a job board
First seen by Remote Rocketship September 14
Still open on Fortrea's site. Checked 5 hours ago.

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 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 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 and maintain out-of-scope work trackers • Assist with Change Order Forms and provide vendor management • Update risk identification, issue resolution, and risk assessment tools; track action items to resolution • Ensure protocol deviations are updated in the RIIM tool • Update the Project Governance Tool monthly and support identification, prevention, and closure of quality compliance gaps • Support audits and investigations, including creating storyboards and ensuring timely closure of audit/inspection CAPAs • Facilitate study team communication through meetings, logs, matrices, directories, distribution lists, SharePoint sites, mailboxes, and project trackers • Collaborate with support functions on TMF uploads and reviews, issue resolution, systems access, training curricula, and delegated tasks • Monitor, escalate, and help enforce redaction of subject-sensitive information and identifiers • Maintain the Lessons Learned tracker • Perform other duties as 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 • 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 the conduct of 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
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