The Senior CDA I is capable of leading Data Management aspects of a clinical study with minimal support and oversight. The Senior CDA I has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement.
Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. May assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
Independently 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
Ability to 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. Mentor less proficient SAS users as appropriate
Independently lead data cleaning activites such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation
Independently manage the database lock process in an efficient and timely manner
DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines. 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
Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications
Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring junior CDAs and/or contractors
Utilizes experience and leadership skills to provide guidance to other team members
BA/BS in relevant field and 5-8 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, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
Previous relevant EDC experience required
Previous vendor/CRO management required
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
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Internal Number: 2018-252
About Seattle Genetics
Revolutionary science meets transformative cancer therapy.
Seattle Genetics is the largest global oncology biotechnology company based in the Pacific Northwest. We are focused on developing and commercializing a new generation of targeted, empowered antibody-based therapies that have the potential to change the foundation of treatment for people with cancer.