This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Acts as Lead Data Reviewer for internal studies, collaborating with Study Directors to ensure timely and thorough data review for GLP and Preclinical Functionality studies
Responsible for performing audits of protocols, SOPs, and quality system elements to ensure compliance with GLP regulations (21 CFR Part 58) and internal procedures
Review and ensure the accuracy and completeness of medical records, surgical records, protocols, and study data
Collaborate with staff to identify, evaluate, and recommend solutions to review and correct findings
Draft study deviations in a timely manner and incorporate Study Director impact assessments
Perform audits of protocol, SOP, and quality system elements to ensure compliance with GLP regulations and internal procedures
Ensure preclinical in-vivo studies are compliant with GLP regulations (21 CFR Part 58) and adhere to internal quality guidelines
Identify and report basic non-compliance within regulations and standards
Collaborate efficiently with different groups, managing movements between various locations around the site according to stakeholder schedules
Requirements:
Preferred: Bachelor’s degree with 3 years of preclinical medical device research experience, or 5 years of relevant work experience supporting preclinical research (e.g., LAR/surgical vet tech)
Background in data management and familiarity with medical device GLP research
Demonstrated understanding in the use of calibrated equipment, controlled drugs, and GLP data collection/retention
Must be able to identify basic non-compliance within regulations and standards