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Seagen
Senior EDC Programmer
Clinical Development Operations - Bothell, Washington - US Field Based
Description
Summary
The Senior EDC Programmer is responsible for the development of the Electronic Data Capture (EDC) system and other related departmental systems for the purpose of collecting and reporting clinical study data. The Senior EDC Programmer has thorough knowledge of FDA regulations and industry standards,
strong technical skills, and is capable of leading infrastructure assessment and improvement.
Principal Responsibilities:
- With limited oversight, perform and/or lead EDC development activities including but not imited to electronic CRF design, visit schedule development, edit check programming, validation requirements, and post-production modifications
- Support and/or lead data reporting activities including gathering and compiling user requirements, development of report specifications and development of automated, standardized and ad hoc reports
- Support and/or lead EDC global library development
- Support and/or lead research, evaluation and development of departmental initiatives and new technologies/innovations to improve EDC Systems processes; may represent the EDC Systems team through working groups (internal and external) and initiatives
vMay contribute to the development, review and implementation of SOPs, templates and processes and other departmental and/or cross functional initiatives
Qualifications:
- Years of experience: 5-10 years
- Requires effective organizational and communication skills
- Expert knowledge of and experience with clinical database design and electronic data capture
systems using Medidata products such as RAVE, a clinical data management systems software
- Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods
or software as it relates to position and profession
- Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
- Strong well-rounded technical skills (MS Word, Excel, PowerPoint)
- Previous experience with C# and SQL Server databases highly valued
- Previous report generation skills using reporting software highly valued
- Detail oriented; performs quality and accurate work
Education
- BA/BS in relevant field strongly preferred
- Rave Study Design and Build Essentials certification highly valued but not required
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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 02/12/2021
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