Responsibilities Serve as Clinical Data Management representative in Operational Committee / fora with the partners, DM vendors or other vendors handling data. Participate in working groups Data protection regulation, setup of data in biomarker group, ePRO, IRT etc. Drive alignment meetings within the data management group. Attend various working groups where data management expertise is required. Perform vendor oversight related to key deliverables eCRF design development, review of the eCRF completion guide, UAT, approve eCRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data transfer specifications with all external data providers lab, ECG, ePRO etc., evaluate trends in DM raised queries, ensuring final transfer of data for archiving including development of site CDs, ensuring coding listings are approved etc. Proactively participate and represent data management in the CTT and provide oversight on progression and status of related activities. Proactively discuss risks management related to data management activities in relation to trial conduct. Review and provide input to protocol and amendment development. Give input to protocol deviations, randomization and stratification plans, tables, figures and listings etc. Ensure procedures for blinding are in place where applicable. Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH / GCP. Attend trial and investigator / monitor meetings as needed. Participate in definition, review and approval of data packages for Data Monitoring Committee's. Review and approve any corrections and updates of data packages. Support timely development, update and maintenance of dashboards. Requirements Bachelor's degree in a scientific or related field. years of hands-on clinical data management experience in the biotech or pharmaceutical industry. Proven end-to-end data management expertise across multiple clinical trials. Experience with oncology clinical trials highly preferred. Deep understanding of clinical trial processes and the drug development lifecycle. Strong leadership experience in data management, including oversight of multiple studies. Proficient with data management systems (, EDC tools) and documentation practices. Advanced knowledge of data management methodologies, tools, and strategies. Solid understanding of GCP, regulatory guidelines, SOPs, and data integrity standards. Familiarity with CDISC standards (especially SDTM) and oncology-specific data requirements preferred Experience in project management and cross-functional team collaboration. #J-18808-Ljbffr Katalyst HealthCares & Life Sciences
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