Clinical Data Standards Manager

Overview Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. Role Clinical Data Standards Manager (CDSM) Responsibilities Act as a functional expert in clinical data standards as defined by Regulatory Authorities and Industry Organizations (e.g., CDISC) for clinical data submissions. Lead cross-functional teams to create data standard driven end-to-end processes and solutions that support the scientific needs of a study/program, ensuring quality, consistency and regulatory compliance with CDISC standards. Serve as a subject matter expert on clinical data standards development, including industry standards and regulations. Set up, lead or actively contribute in Data Standards Governance meetings. Support optimization of data acquisition in clinical trials by streamlining and integrating data to enhance efficiency and data quality. Support and implement strategies and tools for clinical trials standards, change control management, and the exchange of standards information to internal and external stakeholders. Keep abreast of Industry and Regulatory Authority requirements related to data standards and data submission; interpret guidance and perform impact assessments to determine implementation strategy. In support of the argenx clinical trial portfolio, the CDSM will: Develop and maintain the argenx Clinical Data Standards library. Support CDM and DML in creating study-specific unique CRFs and SDTM metadata, implementing clinical data standards at the trial level. Ensure proper training of the CDM and other internal teams in the use of argenx clinical data standards and review of SDTM conversion and data QC at the trial level. Escalate issues to other members of the Clinical Trial Team and/or Indication Development Team as required. The CDSM will also participate in other activities but is not limited to: Lead or participate in initiatives on process improvements focused on data standardization. Participate in regulatory agency inspections and internal audits, when appropriate. Skills and Competencies Knowledge of ICH-GCP and other applicable legislation. CDISC standards (SDTM, CDASH). Eye for detail and strong analytical skills. Ability to work independently. Strong communication and interpersonal skills. Fluent in English (written and spoken). Education, Experience and Qualifications Master’s or Bachelor’s degree in Life Sciences, Information Technology or equivalent by experience. At least 8 years of experience in Clinical Data Management (biotech experience is a plus). Experience working in a Data Standards team. In-depth understanding of Clinical Development processes. Good knowledge of applicable regulatory guidelines. At argenx, all applicants are welcome in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates will handle and protect your personal data. If you have any questions or wish to exercise your privacy rights, please contact our Global Privacy Office by email at #J-18808-Ljbffr