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Seagen Inc Principal Clinical Data Associate in Bothell, Washington

Seagen\ \ \ \

[ Seagen is a global, multi-product biotechnology company dedicated to developing and]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}[ 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 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 Principal CDA is a Management-level CDA capable of leading Data Management aspects of a clinical study with minimal support and oversight. The Principal CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement. This position may manage vendor/CRO relationships.]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}

[ Principal Responsibilities:]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}

[ Independently lead all data management aspects of a clinical study, including on pivotal, blinded, and randomized trials]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}

[ Independently develop DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans Demonstrate critical thinking, alignment-building and discretion to author documents that meet study needs]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}

[ Represent Data Management in governance bodies, product teams and cross-functional groups; lead internal working groups]{open="" sans\",="" sansembeddedfont\",="" \"open="" sansmsfontservice\",="" sans-serif\"=""}

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