
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.
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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.
• Serve as a member of the project team with primary responsibility for documentation requirements supporting Global EDC Solutions tasks • Receive, log, and scan contractual and validation documentation • Assist project teams with validation tasks • Create, produce, print, and track study documentation and controlled documents • Create and execute validation test scripts and document test results • Ensure quality of work • Prioritize workload to meet specified completion dates • Assist with maintaining validation metrics • Perform activities according to Fortrea SOPs, project-specific conventions, Quality Management, and GCP/ICH guidelines • Maintain accurate records of work performed • Perform other duties and special projects as assigned
• University / college degree in life sciences, health sciences, information technology or related subjects from an appropriate accredited institution, or certification in allied health professions • Fluent in English, both written and verbal • 2–4 years of experience in CDM and EDC testing • Hands-on expertise in Rave and Veeva • Neat, methodical, and thorough approach to work with attention to detail • Good concentration skills • Ability to work under pressure and meet demanding deadlines • Effective communication skills and ability to work as part of a team • Relevant and equivalent experience may be considered in lieu of educational requirements • Flexibility to accommodate shift-based working hours
• Remote work arrangement • Flexible shift-based working hours • EEO and accommodations support
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