2 21 CFR Part 11 Jobs with Hybrid or WFH Options

develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes Well-versed in the utilisation of common tools and technologies within clinical trials, including … Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations more »

English (ideally with business French). Nice to Haves Data Protection Officer certification. Knowledge of regulatory requirements specific to the pharmaceutical industry (e.g., FDA 21 CFR Part 11). Experience with Agile or Scrum Methodologies. Proficiency in Electronic Document Management Systems (EDMS) and other quality management more »