
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.
🔥 2 minutes 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.
• Lead development and implementation of clinical solutions for global technical services issues involving EDC tools, SAS programming, and visual analytics • Lead development of visual analytics dashboards using Spotfire or Tableau • Complete assigned work using Medidata Rave, Oracle Inform, or proprietary software according to SOPs, work instructions, and project guidelines • Perform post-production EDC database changes and SAS program enhancements, including edit checks, listings, and protocol deviations • Meet with Data Managers to discuss contractual obligations and timelines • Act as subject matter expert and point of contact for EDC and SAS technical services issues • Provide lead statistical programming support for development and maintenance of SDTM and client standards datasets • Develop and validate custom/complex SDTM domains and handle external data and reconciliations • Develop and implement SDTM automation, standardization, and programming best practices • Plan, execute, and oversee study programming activities, including resource estimation, timelines, quality, and cross-functional/client interaction • Conduct peer review and quality control of study designs • Participate in software validation and process reviews • Monitor new EDC product developments • Forecast resources and allocate project activities to team members • Identify trends, generate reports and metrics, demonstrate programming processes, and assist with ECRF and study document design
• University / college degree in life sciences, health sciences, information technology, or related subjects preferred • Experience and/or education plus relevant work experience equating to a bachelor's degree accepted in lieu of a bachelor’s degree • Relevant and equivalent experience may be considered in lieu of educational requirements • Fluent in English, both written and verbal • 5 to 8 years of relevant work experience in data management and database support, SAS programming, Spotfire, or Tableau development • Good problem-solving skills and a proactive approach • Good oral and written communication skills • Basic knowledge of clinical trial processes, data management, biometrics, and systems applications preferred • Ability to work in a team environment • Ability to work independently under supervision • Proven interpersonal skills
• Medical • Dental • Vision • Life insurance • STD/LTD • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable • Comprehensive benefits for eligible regular full-time or part-time employees working 20 or more hours per week
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