Job Information
Seagen Inc Senior Clinical Data Associate in Bothell, Washington
Seagen\ \ \ \
[ Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagens dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}[ contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}
[ Summary:]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}
[ The Sr. CDA is responsible for leading Data Management aspects of a clinical study with minimal support and oversight and will ensure that study level deliverables are completed on time, with high quality, and in accordance with corporate and regulatory requirements. The Senior CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement.]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}
[ Principal Responsibilities:]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}
[ Lead all data management aspects of a clinical study, including study start-up activities, and guide the study team through change orders and protocol amendments]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}
[ Independently develop DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}
[ Independently lead data cleaning a ]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}