Clinical Data Associate II

Clinical Development Operations Bothell, Washington US Field Based Seattle, Washington South San Francisco, California


Description

Summary: 

The CDA II is capable of leading Data Management aspects of a clinical study with some support and oversight and will ensure that study level deliverables are completed on time, with quality, and in accordance with corporate and regulatory requirements. The CDA II has a working knowledge of FDA regulations and general industry standards and also supports departmental infrastructure development.   

Principal Responsibilities: 

  • Lead all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments 
  • With minimal oversight, develop DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but exercise critical thinking and discretion to tailor documents to study needs 
  • With minimal oversight, 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. Gather cross-functional input to create custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths 
  • Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.) 
  • Run SAS programs, review SAS logs, and generate output. Research and resolve even complex data discrepancies. May program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level 
  • With minimal oversight, manage data deliverables processes, including database locks 
  • 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 
  • Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product 
  • Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems 
  • Demonstrate "everyday leader" qualities 

Qualifications: 

  • Years of experience: 2-7 years; dependent on level of related skills and education 
  • 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 
  • Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively   

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 
  • Oncology experience and/or working knowledge   

Education: 

  • BA/BS in relevant field. Years of experience may substitute for education. 

 

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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