
10,000+ employees
đĽ Healthcare
đ§Ź Biotechnology
đ 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.
đ May 6
đ Germany, Austria â Remote
â° Full Time
đ˘ Junior
đĄ Mid-level
đ§Ş Clinical Research
đť Ghost score 55%
đŁď¸đŠđŞ German Required
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10,000+ employees
đĽ Healthcare
đ§Ź Biotechnology
đ 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.
⢠Support management of clinical trial sites in compliance with Fortrea SOPs, ICH-GCP, study protocols, and sponsor requirements, with appropriate supervision ⢠Assist in preparing and conducting site monitoring activities, including site initiation, routine monitoring, and close-out visits ⢠Perform source data verification (SDV), support query resolution, and review eCRFs to ensure data quality and completeness ⢠Maintain and update essential trial documentation in eTMF and sponsor systems to support inspection readiness ⢠Support investigational product (IP) tracking and accountability checks in collaboration with the study team ⢠Collaborate with cross-functional teams and escalate issues appropriately, contributing to site performance, quality, and timelines ⢠Contribute to clinical studies across Oncology, Dermatology, Respiratory, Cardiology, and Diabetes therapeutic areas
⢠University or college degree in life sciences, nursing, pharmacy, or a related field; relevant internships or equivalent experience will be considered ⢠Minimum of 12 months of onsite monitoring experience ⢠Basic understanding of ICH-GCP guidelines and clinical trial processes ⢠Strong attention to detail ⢠Willingness to learn ⢠Ability to follow established procedures and documentation standards ⢠Fluency in German and English, both written and spoken ⢠Comfortable using clinical systems and tools ⢠Openness to travel as required for site visits
⢠Structured and supportive environment with clear development pathways and mentoring ⢠Hands-on exposure to global clinical trials and multiple therapeutic areas ⢠Formal training programs ⢠Modern clinical systems ⢠Continuous learning opportunities ⢠Flexible work model ⢠Competitive benefits ⢠Collaborative culture ⢠Culture valuing quality and well-being
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