In this role, you will be responsible for the creation and review of Data Transfer Agreements, the correlation and/or entry of preclinical and clinical data into excel and the conduct of tasks performed within compliance of the study protocol. Responsible for acquisition of study data from data sources and processing of data through specialized software. Generate and complete, SEND datasets for regulatory submission and implementing CDISC standards. Responsible for the preparation of the required nSDRG (Nonclinical Study Data Reviewer’s Guide) document and Data Define file. Proficient use of SEND validation tools and the ability to resolve or explain findings. Perform quality control review on the complete SEND datasets, with great attention to detail to ensure data accuracy and alignment with the study report.
We are looking for candidates who have a passion for learning and teaching, with the patience and listening skills to appeal to the perspectives and interests of others. If you are able to balance confidence with humility while driving quality and efficient projects, then you’ll be right at home here at BioAgilytix.