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Clinical Data Associate II

Seattle Genetics

This is a Full-time position in Bothell, WA posted December 30, 2020.

Seattle Genetics Clinical Development Operations ⋅ Bothell, Washington|US Field Based|Seattle, WashingtonDescriptionSummary: The CDA II is capable of leading Clinical Data Management aspects of a clinical study with some support and oversight.

The CDA II has a working knowledge of FDA regulations and general industry standards and supports departmental infrastructure development.

Responsibilities: Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of productWith minimal oversight, 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 plansRun SAS programs, review SAS logs, and generate output.

Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill levelWith minimal oversight, lead data cleaning activities such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliationWith minimal oversight, manage the database lock process in an efficient and timely mannerDM Project Management: With oversight, ensure data management deliverables are met on time.

Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.

Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables.

Provide solutions for data management issues that arise during study conductPerform medical coding utilizing MedDRA and WHO-DRUG, as appropriateDevelop and assist in maintenance of department tools, templates, guidelines, SOPs, and systemsDemonstrates “everyday leader” qualitiesQualifications: BA/BS in relevant field and 2-5 years experience.

Years of experience may substitute for educationRequires effective organizational and communication skillsTechnologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and professionDetail oriented; performs quality and accurate workThorough knowledge of FDA regulations and ICH GCP guidelines and the DM LifecycleSubject matter expertise may substitute for broader DM lifecycle knowledgePreferred: Previous experience with RTSM/IWRS and ePRO systems.Database development experienceSAS programming experienceKnowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trialsPrevious relevant EDC experiencePrevious vendor/CRO managementAs the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families.

Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

To learn more about Seagen, please visit www.seagen.com.Seagen is an equal opportunity employer.

All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual #LI-EK1Apply Here:https://www.click2apply.net/p7MbEgTWMOYqFZWWUdwEOPI127813920