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Seagen
Clinical Data Associate II
Clinical Development Operations - Bothell, Washington - US Field Based - Seattle, Washington
Description
Summary
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 product
- With 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 plans
- Run 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 level
- With 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 reconciliation
- With minimal oversight, manage the database lock process in an efficient and timely manner
- DM 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 conduct
- Perform medical coding utilizing MedDRA and WHO-DRUG, as appropriate
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
- Demonstrates "everyday leader" qualities
Qualifications:
- BA/BS in relevant field and 2-5 years experience. Years of experience may substitute for education
- Requires effective organizational and communication skills
- Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
- Detail oriented; performs quality and accurate work
- Thorough knowledge of FDA regulations and ICH GCP guidelines and the DM Lifecycle
- Subject matter expertise may substitute for broader DM lifecycle knowledge
Preferred:
- Previous experience with RTSM/IWRS and ePRO systems.
- Database development experience
- SAS programming experience
- Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Previous relevant EDC experience
- Previous vendor/CRO management
As 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 orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
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Seagen
Seagen is an Equal Opportunity Employer
Submitted: 12/25/2020
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