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Associate Director Clinical Data Management Washington

Seattle Genetics

This is a Full-time position in bothell, wa posted June 11, 2021.

Seattle Genetics Clinical Development Operations ⋅ US Field Based|Bothell, WashingtonDescriptionSummary:The AD, Clinical Data Management will direct Data Management activities for Phase I-IV studies and will ensure that product and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements.

This position will be responsible for managing salaried and contract CDAs and managers.PrincipalResponsibilities:Align with and support management and corporateobjectivesManage CDAs and managers effectively by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews.

Lead hiring and trainingactivitiesasneededManage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product.

Assist in the selection of vendors/CROs ( RFPs, attend site audits)Guide team members through the development of 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 reviewplansGuide team members through data cleaningactivitiessuch as but not limited to Study Team data reviews, SAE reconciliation, non-CRF data reconciliation, and data cleaning timeline/strategydevelopmentGuide team members through the database lock process in an efficient and timely mannerDM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per studytimelinesPerform medical coding utilizing MedDRA and WHO-DRUG, as appropriatePerform study resourcing and budget support asappropriateMay program SAS Non-System Edit Checks (NSECs) and/or SAS Data Listings.

Mentor less proficient SAS users as appropriateDirect and guide team through DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomizedtrialsDrive and guide complex process andinitiativesCommunicate and message information to multiple levels of leadership appropriately; applying appropriate level of detail to audience to ensure efficient utilization ofresourceResearch, evaluate, and direct departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes arerequiredEncourage collaboration through relationship building with other leaders; ability to influence withoutauthoritySupport of implementation of data standardsQualifications:10+years experienceand 5+ years management experienceEducation:BA/BS in relevant fieldAs 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 is an equal opportunity employer.

All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.#LI-JL1Apply Here :